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    Endocrinology Newsmakers: Drugmakers work on triple agonist treatments, gene therapies to fight diabetes

    Endocrinology Newsmakers: Drugmakers work on triple agonist treatments, gene therapies to fight diabetes

    Endocrinology, a medicinal branch that deals with endocrine and metabolic disorders, is witnessing cutting-edge drug research to develop advanced drugs that can treat diabetes, obesity, hypoparathyroidism and other disorders.The endocrinology market is witnessing impressive growth — it is growing at a compound annual growth rate (CAGR) of 7.82 percent. Between 2023 and 2027, the market is poised to increase by US$ 36.5 billion. It includes treatments for various medical conditions, such as type 1 and type 2 diabetes, obesity, hypogonadism (a condition where the body’s sex glands produce little or no hormones), dwarfism, hypo or hyperparathyroidism, acromegaly (abnormal growth of the hands, feet, and face, caused by the overproduction of growth hormone by the pituitary gland) and congenital adrenal hyperplasia (a genetic disorder that affects the adrenal glands).The market is dominated by diabetes treatment drugs — valued at around US$ 48.7 billion in 2018, these are expected to generate US$ 78.3 billion by the end of 2026. The market for obesity drugs is also expected to reach US$ 50 billion by 2030.The top companies in this segment include Novo Nordisk, Eli Lilly, Merck, Sanofi, AstraZeneca and Boehringer Ingelheim. Several biotech companies have joined the race to capture a share of the lucrative market for diabetes and obesity drugs.Access the Endocrinology Newsmakers Dashboard (Free Excel)Lilly’s Mounjaro, Novo’s Wegovy gear up for larger share of obesity pieIn May 2022, Lilly’s potential blockbuster Mounjaro (tirzepatide) was approved by the US Food and Drug Administration (FDA) as a once-weekly subcutaneous injection to treat adults with type 2 diabetes. Mounjaro is the first and only dual targeted glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist on the market, and has helped patients achieve a body weight loss of over 20 percent in clinical trials. Novo Nordisk’s Wegovy (semaglutide), the first and only once-weekly GLP-1 receptor agonist approved for weight management in people with obesity, has been found to help patients lose up to 15 percent of their body weight in over 68 weeks. In late 2022, the drug received FDA approval to treat obesity in pediatric patients aged 12 years and older.Last October, FDA granted fast track review designation to Mounjaro as a treatment for obesity. Lilly plans to go to the FDA soon and expects to get approval for the drug this year. Once approved, Mounjaro will give Wegovy a tough fight in the obesity market. Analysts predict Mounjaro to generate around US$ 8.1 billion in annual sales by 2028, while Wegovy is expected to bring in US$ 7 billion by 2030. Meanwhile, Amgen’s AMG 133 is also in early-stage trials for obesity. Access the Endocrinology Newsmakers Dashboard (Free Excel) ‘Skinny shot’ diabetes drugs face supply shortages; Lilly plans to double capacityFollowing its approval in the US in mid-2021, Wegovy quickly became the go-to “skinny shot” drug in Hollywood, thanks to its impressive weight reduction data. But the drug hit a supply shortage in late 2021 due to manufacturing issues, which the manufacturer managed to fix in the second half of 2022. Novo’s blockbuster type 2 diabetes drug Ozempic is also in limited supply, but the drugmaker expects the availability to return to normal around mid-March.The supply constraints of Wegovy and Ozempic, coupled with the craze around using diabetes drugs for weight loss, sparked interest in Lilly’s Mounjaro. But Mounjaro, along with another Lilly drug Trulicity, began facing supply issues last December. While Lilly has fixed Mounjaro’s supply issues for the time being, it plans to double its manufacturing capacity by the year end to avoid any such shortages in the future.Meanwhile, the American Diabetes Association and Mutual Aid Diabetes have sounded an alarm, saying the off-label use of diabetes drugs for weight loss may cause shortages and affect diabetes patients.Access the Endocrinology Newsmakers Dashboard (Free Excel)Provention launches treatment for type 1 diabetes; Novo retains market dominanceIn November, Provention Bio’s Tzield (teplizumab) bagged FDA approval as a preventive treatment for type 1 diabetes in individuals eight years or older who are in stage 2 of the disease. The injectable drug is the first treatment in the US to delay progression of the autoimmune disease.Novo remained the dominant player in the diabetes and obesity market, clocking sales of US$ 22.8 billion (DKK 156.4 billion) in 2022 in this segment. Ozempic’s sales increased by 77 percent to US$ 8.6 billion (DKK 59.8 billion). The Danish company consolidated its position further by purchasing Dicerna Pharma for US$ 3.3 billion in 2021 for its RNA interference (RNAi) technology.Novo is planning to file for approval of its once-weekly insulin icodec for type 2 diabetes in the US, the EU and China in the first half of 2023. It is also running a phase 1 trial of Ozempic as a once-weekly oral treatment.In 2022, sales of Lilly’s blockbuster drug Trulicity (dulaglutide) touched US$ 7.4 billion. Two other drugs, Humalog and Jardiance, generated US$ 2.1 billion each in sales. In addition, Lilly’s partner Boehringer Ingelheim also reported US$ 2.55 billion (€ 2.5 billion) sales of Jardiance in the first half of 2022.Biosimilar drugmaker Biocon Biologics acquired Viatris’ biosimilars business for a total of US$ 3.34 billion, strengthening its presence in the diabetes, tumors and autoimmune diseases market. Viatris’ portfolio is expected to generate sales of over US$ 1 billion for Biocon in 2023.Access the Endocrinology Newsmakers Dashboard (Free Excel)Drugmakers work on triple agonist therapies to treat diabetes, obesitySeveral drugmakers are working on triple agonist therapies that target multiple receptors, such as GLP-1, GIP and glucagon (GCG). These drugs, such as Novo and partner Marcadia’s MAR423, Hanmi’s HM1521, Sanofi’s SAR441255, and Eli Lilly’s retatrutide, are currently in early- to mid-stage trials. Studies have shown that these triple agonists are more effective in reducing body weight and improving glucose control compared to mono- or dual-incretin receptor agonists.In addition, a few triple drug combinations containing metformin, DPP4 inhibitors and SGLT2 inhibitors have recently been approved. Treatments such as Astra’s Qternmet XR and Lilly-BI’s Trijardy XR have shown significant improvement in glycemic control and are generally well tolerated by patients.Access the Endocrinology Newsmakers Dashboard (Free Excel)TheracosBio’s oral med for diabetes approved; gene therapies gather interest Recently, TheracosBio’s Brenzavvy was approved by the agency as an oral medication for type 2 diabetes. And Marinus Pharmaceuticals’ oral testosterone replacement therapy Kyzatrex received FDA’s nod last year for a range of diseases in men that arise from deficiency or absence of endogenous testosterone. New York-based Oramed is currently conducting a phase 1 trial of its oral GLP-1 drug – ORMD-0901 – as a treatment for type 2 diabetes.Meanwhile, Vertex and Arbor Biotechnologies are working on a gene therapy (VX-880) for type 1 diabetes. BridgeBio Pharma’s BBP-631 adeno-associated virus (AAV) gene therapy for congenital adrenal hyperplasia is in phase 1/2 trials. And Swedish biotech Diamyd is carrying out phase 3 trials of its type 1 diabetes vaccine.In other medical conditions, Ascendis Pharma’s TransCon PTH, a long-acting prodrug of parathyroid hormone, has a PDUFA date in April 2023. If approved, it would become the first hormone replacement therapy to address the underlying cause of hypoparathyroidism. Crinetics Pharmaceuticals’ Paltusotine, a non-peptide somatostatin type 2 (SST2) receptor agonist, is currently in phase 3 trials for acromegaly, representing a new class of oral once-daily medication.Access the Endocrinology Newsmakers Dashboard (Free Excel)Our viewDiabetes and obesity have reached epidemic proportions in the recent decades, while other endocrine disorders such as hypoparathyroidism are also growing rapidly the world over.According to the World Health Organization, around 422 million people worldwide have diabetes, and 1.5 million deaths are directly attributed to diabetes each year.While factors such as long working hours, sedentary lifestyles, and unhealthy eating and drinking habits are contributing to the rise of these diseases, drugmakers are doing some cutting edge research for these conditions. Given this scenario, endocrinology should see a lot of pathbreaking drugs in the coming years.

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    https://www.pharmacompass.com/radio-compass-blog/endocrinology-newsmakers-drugmakers-work-on-triple-agonist-treatments-oral-insulin-to-fight-diabetes

    #PharmaFlow by PHARMACOMPASS
    02 Mar 2023
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    America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data

    America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data

    Nearly every year, drugmakers ring in the new year with drug price increases in the US. This year too, prices of over 450 prescription medicines increased by an average of around 5 percent at the start of January. This, when high drug prices have been one of the biggest political issues in the US over the last few years. PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed. View US Medicare Part D 2019 Drug Spending (Free Excel Available) Rising healthcare, drug spends in US Over the last several years, we have repeatedly heard political leaders in the US complain about high drug prices. Yet, drug prices and healthcare spends have risen unabated. America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8 trillion, accounting for 17.7 percent of the gross domestic product (GDP). During the year, prescription drug spend increased by 5.7 percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7 percent to US$ 799.4 billion. President Joe Biden recently stressed on the need to cap the prices of essential drugs, and said that the average American pays the highest prices for prescription drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.  Pharma companies, on the other hand, have vehemently argued against any price cuts in the US, saying price cuts would hinder drug research and development for all diseases. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Patented drugs account for 80.3 percent of total Part D spend Medicare is the US federal government’s program that provides health insurance to most people who are 65 years or older. Medicare’s Part D plan provides outpatient drug coverage through private insurance companies that have contracts with the federal government. Eligible people have to choose and enroll in a private prescription drug plan for Part D coverage. Medicare Part B, on the other hand, covers a wide variety of medically necessary outpatient services and some preventative services. Prescription drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent of the total spend for the year. Generic drugs made up for the remaining 19.7 percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8 billion were sold under Part D, accounting for 21 percent of the total spend under the program. View US Medicare Part D 2019 Drug Spending (Free Excel Available)   Eliquis ranks highest on Medicare’s brand drug spend Under Part D, endocrinology and oncology were the two therapeutic areas that generated maximum revenue for pharma companies, driving home sales of over US$ 31.8 billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of around US$ 22.9 billion. Among branded drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018. Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each under the program. Amongst generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the overall dosage units sold also jumped higher by 2.25 billion units to 111.35 billion.  The sales ranking of Part D does bare some similarities with the global ranking of highest selling drugs. In 2020, Humira had retained its position as the highest selling drug in the world, generating sales of US$ 20.4 billion. Both Eliquis and Revlimid had retained their ranking as the third and fourth most selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global sales in 2020. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Medicare’s inability to negotiate prices costs American taxpayers billions of dollars Over the years, drug companies have used Medicare’s inability to negotiate prices under Part D to increase the prices of their drugs significantly and rip off huge profits, a three-year-long US House Oversight Committee investigation has revealed. US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between 2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.   Elsewhere in the world, the same drugmakers are bending over backwards to get into medical insurance programs. For instance, China reported that several international pharma firms, many of them headquartered in the US, slashed the prices of their drugs by up to 94 percent to get into the country’s national medical insurance coverage. In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022 if an expensive Alzheimer’s drug, Aduhelm, is included in the list. In order to ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Our view President Biden's Build Back Better legislation, which the House passed last month, is up for vote in the Senate. The legislation contains provisions that would allow Medicare to negotiate the prices of some expensive drugs, penalize drugmakers who raise prices faster than inflation and cap out-of-pocket costs for insulin at US$ 35 per month. However, chances of the bill being passed in its present form are slim. Even if the Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025. The number would increase over the years, reaching 100 in six years, and hence forth grow by 20 drugs a year. It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.  View US Medicare Part D 2019 Drug Spending (Free Excel Available)    

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    https://www.pharmacompass.com/radio-compass-blog/america-s-drug-price-hike-conundrum-in-backdrop-of-2019-medicare-part-d-data

    #PharmaFlow by PHARMACOMPASS
    06 Jan 2022
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    Top drugs and pharmaceutical companies of 2019 by revenues

    Top drugs and pharmaceutical companies of 2019 by revenues

    Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

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    https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
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    COVID-19: India restricts drug exports amid rising prices of essential bulk drugs; FDA announces first drug shortage

    COVID-19: India restricts drug exports amid rising prices of essential bulk drugs; FDA announces first drug shortage

    Now that it has been established that the novel coronavirus is going to globally impact the drug supply chain, it becomes imperative to analyze the extent of the impact. Since the outbreak of the novel coronavirus — COVID-19 — in December, PharmaCompass has been constantly reaching out to manufacturers around the world to assess the current state of the drug supply chain. This week, we share our preliminary analysis based on the feedback we have received from drug manufacturers around the world. Drug shortages are for real   Last week, the US Food and Drug Administration (FDA) announced the first human drug shortage as a result of the coronavirus outbreak. In addition, the FDA announced it was tracking 20 drugs that could face shortages. Some generic drugmakers are predicting shortages as early as in June or July, due to the novel coronavirus. The FDA did not disclose the name of the drug in shortage or the 20 drugs it is tracking, as this is considered ‘confidential commercial information’.  In India, a committee constituted by the country’s Department of Pharmaceuticals started monitoring the availability of 58 active pharmaceutical ingredients (APIs) to take preventive measures against illegal hoarding and black-marketing in the country. According to a report published in The Economic Times, after reviewing the list of drugs, 34 were found to have no alternatives which include critical and essential drugs like potassium clavulanate, ceftriaxone sodium sterile, piperacillin tazobactam, meropenem, vancomycin, gentamycin and ciprofloxacin. This was immediately followed by the Indian government restricting the exports of 13 APIs along with some of their finished formulations. The list includes paracetamol, tinidazole, metronidazole, acyclovir, vitamin B1, vitamin B6, vitamin B12, progesterone, chloramphenicol and neomycin. For most of the products on this list, India is a net importer, as there is little domestic manufacturing of these APIs. COVID-19 is also likely to impact bottomlines. Leading generic drugmaker Mylan said it expects the coronavirus outbreak to impact its financial results while some of the largest drugmakers — including AstraZeneca, Merck and Pfizer — have said that the coronavirus outbreak could affect their supplies or sales. Paracetamol affected; prices double in less regulated markets   The decline in industrial activity in China is certainly taking its toll, as drugs which are on the World Health Organization’s Model list of Essential Medicines are beginning to face significant price increases in the wake of disruption of key starting raw materials for bulk drugs.  The export restriction out of India on commonly used analgesic, Paracetamol — sold under the brand names such as Tylenol (in the US), Panadol (in the UK), Dafalgan (France) and Crocin (India) — is not surprising as the API has witnessed almost doubling of prices in less regulated markets because exports of its key building block para-amino phenol (PAP) have dramatically reduced from China.  While there are only a few manufacturers who produce paracetamol without being dependent on Chinese PAP, a few major manufacturers in India depend almost completely on Chinese PAP for their paracetamol production and usually only keep three to four months of inventory. By the end of February, their inventory stockpiles had halved and in the event of a continued supply disruption, their entire inventory pipeline is likely to dry out. In addition, Chinese paracetamol manufacturers, who export a significant amount of their bulk ingredient production globally, including to India, are also currently unable to export. This is beginning to create the potential of panic among sourcing executives across the world. Several antibiotics also in danger of acute shortages   While paracetamol was listed on the API watch list circulated by India’s Department of Pharmaceuticals, our survey has revealed that other products on the list like ciprofloxacin, amoxicillin and azithromycin are also facing severe raw material shortages. As a result, the prices of these bulk drugs have also increased sharply. In a statement to The Economic Times, leading Indian generic manufacturer Mankind Pharma’s chairman and managing director said amoxicillin is the most commonly used API to manufacture antibiotics and the company has invested Rs 1 billion (US$ 14 million) in placing irregular orders with vendors to try and address the potential shortage that is expected. He went on to say that if the situation continues until April, there will be an acute shortage. In a statement to the US House of Representatives last October, Janet Woodcock, the FDA’s Director of Center of Drug Evaluation and Research, said the FDA has determined that there are three WHO Essential Medicines whose API manufacturers are based only in China. The three medicines are: capreomycin, streptomycin (both indicated to treat Mycobacterium tuberculosis) and sulfadiazine (used to treat chancroid and trachoma). Streptomycin is also on the watch list published by India’s Department of Pharmaceuticals along with commonly used anti-hypertensives like losartan, valsartan, telmisartan and olmesartan and diabetes treatment metformin. Intermediates becoming a problem for generic drugmakers   PharmaCompass’ discussions have also revealed that in many cases while API manufacturing factories in China have returned to work, there are disruptions in the availability of raw materials and/or logistics at sea ports and airports which have led to unavailability of supplies.  While the FDA has a list of the number of API facilities in China which are in a position to supply to the United States, Woodcock said in her statement that the FDA “cannot determine with any precision the volume of API that China is actually producing, or the volume of APIs manufactured in China that is entering the US market.” This visibility reduces drastically when one has to assess the dependence of each API manufacturer around the world on China for intermediates. Our discussions have revealed that it is these intermediates which are becoming a problem for most API manufacturers, even those based in India. It was worth highlighting that a manufacturing process change at an intermediate stage of commonly used blood pressure medicine valsartan resulted in the recall of millions of pills as it was found to contain a cancer causing impurity above acceptable levels. Similarly, in 2008, the adulteration of heparin in China, which killed 81 people and left 785 severely injured, was an outcome of the subcontracting of precursor chemicals of Heparin. Our view   The over-dependence on China for key starting materials has been the subject of discussion ever since we launched PharmaCompass. Rosemary Gibson explored this subject in detail in her book China Rx: Exposing the Risks of America’s Dependence on China for Medicine. The restrictions imposed on industrial activity and transportation in China in the first two months of this year has resulted in NASA’s satellite images showing a decline in pollution levels over China. While China works towards getting its industrial and transportation engine up and running to 2019 levels, the outbreak has spread to other countries which will further increase the demand for drugs to fight the virus.  This is a time when the pharmaceutical industry needs to act responsibly and make decisions which are in the best interests of patients globally. Sharing information is one such step — it will allow for drug stockpiles and inventories that exist to be re-distributed to areas which need them most. For, in the event of an urgent need, drugs will become available to those who are most in need.  

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    #Phispers by PHARMACOMPASS
    04 Mar 2020
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    Analyzing over US$ 90 billion of Medicare Prescription Drug (Part D) Spending in 2016

    Analyzing over US$ 90 billion of Medicare Prescription Drug (Part D) Spending in 2016

    This week, PharmaCompass reviews the recently released data on prescription drugs paid for under the Medicare Part D Prescription Drug Program in the United States in calendar year 2016. But first, let’s understand what is Medicare. Medicare is the federal health insurance program in the US. In 2017, it covered 58.4 million people — 49.5 million aged 65 and older, and 8.9 million disabled.  Prescription drug coverage under this program was started in 2006, and is known as Medicare Part D. As part of this coverage, the Centers for Medicare & Medicaid Services (CMS) contracts insurance companies and other private companies, known as plan sponsors, that offer prescription drug plans to their beneficiaries with varying drug coverage and cost-sharing requirements. In 2017, the Congressional Budget Office (CBO) had estimated that spending on Medicare Part D would reach US$ 94 billion, or about 16 percent of all Medicare expenditures for the year. Click here to access the compilation of Medicare Part D Prescriber Summary Report According to the CBO, Medicare Part D is the most significant expansion of the Medicare program since it was created by Congress in 1965. With more than 1.48 billion claims from beneficiaries enrolled under the Part D prescription drug benefit program under its umbrella, our analysis of Medicare Part D provides valuable insights into how elderly Americans use prescription drugs. Top 10 drugs by cost: The ones that bore the highest cost burden for Medicare   As in 2015, in 2016 too Gilead’s Hepatitis C treatment — Ledipasvir/Sofosbuvir (Harvoni) — remained the single drug highest payout under the Medicare Part D Prescription Drug Program with a total cost of US$ 4.4 billion.  As Gilead continued to face competition from AbbVie and Merck in the Hepatitis C space, the spending on Harvoni was down 37 percent from US$ 7.03 billion in 2015. Click here to access the compilation of Medicare Part D Prescriber Summary Report Celgene’s cancer treatment, Lenalidomide (Revlimid), Sanofi and Merck’s diabetes treatments and AstraZeneca’s Crestor (Rosuvastatin Calcium) for cholesterol followed Harvoni. All together, they cost the Medicare program over US$ 10 billion. Generic Name Number of Medicare Part D Claims Number of Medicare Beneficiaries Number of Prescribers Aggregate Cost Paid for Part D Claims (In USD) LEDIPASVIR/ SOFOSBUVIR (HARVONI) 141,665 52,782 12,097 4,398,534,465 LENALIDOMIDE 239,049 35,368 10,382 2,661,106,127 LANTUS SOLOSTAR (INSULIN GLARGINE, HUM.REC.ANLOG ) 5,028,485 1,075,248 245,447 2,526,048,766 SITAGLIPTIN PHOSPHATE 4,742,505 864,442 206,223 2,440,013,513 ROSUVASTATIN CALCIUM 6,012,444 1,560,050 249,981 2,322,724,007 FLUTICASONE/SALMETEROL 5,194,391 1,196,007 275,442 2,319,808,482 PREGABALIN 4,940,115 852,497 267,532 2,098,953,250 RIVAROXABAN 4,403,332 807,820 252,141 1,954,748,890 APIXABAN 4,455,782 826,969 231,631 1,926,107,484 TIOTROPIUM BROMIDE 4,153,162 903,494 235,564 1,818,857,361 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by claims: The most commonly used drugs of 2016   With 46.6 million claims, the thyroid hormone deficiency treatment — Levothyroxine Sodium — retained its position of being the most claimed product under Medicare’s Part D Prescription Drug Program in 2016. The number of Medicare Part D claims includes original prescriptions and refills. Following Levothyroxine Sodium was the lipid-lowering agent — Atorvastatin Calcium — which had 44.5 million Medicare Part D claims that were filed by almost 9.4 million beneficiaries. Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 ATORVASTATIN CALCIUM 494,973 44,595,686 9,435,633 AMLODIPINE BESYLATE 497,017 39,913,468 7,802,905 LISINOPRIL 490,452 39,469,840 8,009,954 OMEPRAZOLE 492,951 32,909,236 7,001,160 METFORMIN HCL 611,700 31,007,932 6,394,014 SIMVASTATIN 380,560 29,687,947 6,201,911 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 FUROSEMIDE 488,352 27,878,243 5,421,598 GABAPENTIN 555,997 27,627,466 5,363,382 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by prescribers: Medicines that were most popular with doctors   Among the prescribers, albuterol sulfate (salbutamol) and Diltiazem had over 900,000 unique providers (or doctors) prescribing the drug. Albuterol (salbutamol) is used to provide quick relief from wheezing and shortness of breath while Diltiazem is used to prevent chest pain (angina). Also on the list of popular drugs with prescribers is Hydrocodone-Acetaminophen. With more doctors prescribing Hydrocodone-Acetaminophen (an opioid) than commonly used antibiotics, such as Cephalexin, Ciprofloxacin and Amoxicillin, the series of new FDA initiatives to combat the epidemic of opioid misuse and abuse should change the position of opioids in the top 10 drugs by prescribers in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries ALBUTEROL SULFATE 985,427 13,100,354 5,417,718 DILTIAZEM HCL 931,159 8,142,004 1,982,550 POTASSIUM CHLORIDE 879,491 18,945,969 4,278,000 PEN NEEDLE, DIABETIC 677,210 5,281,778 1,795,046 LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 METFORMIN HCL 611,700 31,007,932 6,394,014 CEPHALEXIN 597,647 5,603,879 3,933,373 CIPROFLOXACIN HCL 594,129 7,000,081 4,851,657 AZITHROMYCIN 591,028 7,958,625 5,734,122   What does the future hold?   Although the Part D Prescriber PUF (public use file) has a wealth of information on payment and utilization for Medicare Part D prescriptions, the dataset has a number of limitations.  Of particular importance is the fact that the data may not be representative of a physician’s entire practice or all of Medicare as it only includes information on beneficiaries enrolled in the Medicare Part D prescription drug program (i.e., approximately two-thirds of all Medicare beneficiaries).   Click here to access the compilation of Medicare Part D Prescriber Summary Report Last month, the Office of the Inspector General (OIG) reviewed the Part D claims data for the years 2011 to 2015 for brand-name drugs. The OIG’s report found that the total reimbursement for all brand-name drugs in Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions for these drugs.  With soaring drug prices being an issue for regular debate in the Unites States and President Trump announcing that his team will use strategies to strengthen the negotiating powers under Medicare Part D and Part B, it remains to be seen how the data on prescription drugs paid for under the Medicare Part D Prescription Drug Program will change in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report  

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    #PharmaFlow by PHARMACOMPASS
    05 Jul 2018
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    Ghosts of GSK’s billion dollar mistake return; New date for electronic submissions of DMFs

    Ghosts of GSK’s billion dollar mistake return; New date for electronic submissions of DMFs

    This week, Phispers tells us why David Hung’s taking charge as CEO of Axovant could signal the revival of an Alzheimer’s compound shelved by GSK. While, the FDA has extended compliance date for submitting DMFs in electronic format, there are also indications that there will be more FDA inspections in India. Plus, there is news on companies like Fresenius, Stada, Ajanta Pharma, Merck and Teva. Read on.   FDA extends compliance date for electronic DMF submissions to May, 2018   On April 7, the US Food and Drug Administration (FDA) announced it is extending the compliance date  for submitting DMFs in Electronic Common Technical Document (eCTD) format to May 5, 2018. “DMF submissions that are not submitted in eCTD format after this date will be rejected,” the FDA website said. “Presentations on submitting in eCTD format created prior to April 7, 2017 will have the incorrect compliance date for DMFs,” it added. Electronic submissions of Drug Master Files (DMFs) were supposed to become mandatory from May 5, 2017.  The news coincides with the US Senate’s confirmation hearing for Scott Gottlieb, on April 7. Gottlieb was President Trump’s nominee to be the next Commissioner of the FDA. Gottlieb was with the FDA when the regulator launched its Pharmaceutical cGMPs for the 21st Century initiative. Out of five guidance documents listed as part of this initiative, only one has been finalized. With Gottlieb heading back, Ajaz Hussain, (former FDA deputy office director and president of the National Institute for Pharmaceutical Technology and Education of NIPTE), Vadim Gurvich (executive director of NIPTE) and Peter J. Pitts (president of the Center for Medicine in the Public Interest and a former FDA associate commissioner) shared their perspective on how Trump and the FDA can create a pharmaceutical manufacturing renaissance in a blog posted on Morning Consult. Axovant appoints new CEO and revives ghosts of GSK’s billion dollar mistake   After selling Medivation to Pfizer for US $ 14 billion and exiting with US $ 354 million for himself, David Hung is now the CEO of Axovant, the company which we wrote about two years ago, as we asked the question — Did a 29-year old show GSK that it made a billion dollar mistake? Back in December 2014,Vivek Ramaswamy, CEO and Founder of Roivant Neurosciences and Axovant, had bought an old Alzheimer’s drug that GSK had dropped for US $ 5 million. In October 2014, Roivant had spun off a subsidiary by the name of Axovant, which then bought the GSK drug. GSK had shelved the compound — 5HT6 — after testing it in 13 trials and on 1,250 patients. Six months after purchasing the compound from GSK, and without doing any clinical development, the drug resulted in the biggest biotech IPO ever for Axovant, which got valued at US $ 2 billion. Since then, Ramaswamy has been setting up more companies. Throughout, Ramaswamy has recruited high-profile executives to run his companies. And who could be more high profile than Hung? The stock market cheered his appointment — Axovant’s stock was up 28 percent earlier this week after Hung was announced its CEO. Axovant is looking for positive data that GSK had gathered for its 5HT6 Alzheimer’s drug. And a number of senior players in the industry say Axovant has a decent shot at taking the successful dose back into the clinic. With Hung joining, it seems the drug discarded by GSK does indeed have merit. Fresenius in talks to buy Akorn; Stada sold for US $5.6 billion   Fresenius SE said it is in talks to buy US generic drugmaker - Akorn Inc. Though discussions are underway, there is no certainty of a deal, Fresenius said. A spokeswoman for Akorn declined to comment. The CEO of Fresenius, Stephan Sturm, who took charge in July 2016, has been expanding the group’s global reach through acquisitions. Last year, the company bought Spanish hospital group IDC Salud Holding SLU, also known as Quironsalud, for US $ 6.11 billion (Euro 5.76 billion) in the company’s largest-ever acquisition. Akorn could complement Fresenius’ Kabi medicines division, which specializes in intravenous drugs, and accounts for about a fifth of the company’s revenue. Stada sell-off: Stada Arzneimittel AG has been sold to Bain Capital and Cinven for US $ 5.6 billion (Euros 5.3 billion), after a long-fought takeover contest. The sell-off will give the equity firms control of one of the last independent generic-drug businesses in Europe. The deal would give buyers access to German and Russian markets for OTC and copycat medicines. It marks another step in the consolidation of the generics industry.  FDA inspections in India to rise, says Edelweiss Securities   India’s pharmaceutical sector is the largest supplier of drugs to the US. However, “quality issues are an ongoing challenge for the Indian pharmaceutical industry,” Mary Lou Valdez, FDA’s associate commissioner for international programs wrote in a blog.  Of the 42 warning letters sent out by FDA’s office of manufacturing quality last year, about one-fifth (9) were addressed to Indian facilities. The number could rise over the next three years as the FDA would inspect 190 facilities that it could not inspect in the past five years, wrote Edelweiss Securities.  FDA inspections in India and China have doubled since 2012. This has led to a spurt in warning letters as well. GSK to withdraw 600,000 inhalers; no observations for Ajanta   GSK would be voluntarily recalling close to 600,000 Ventolin asthma inhalers across the US, says the FDA. The recall is due to a leak observed in some of the products. The exact number of inhalers to be recalled, as reported by the FDA, is 593,088. These were produced in GSK’s Zebulon, North Carolina manufacturing facility. This is the second time in just over a year that the plant has faced problems with leaking inhalers. Ajanta Pharma: On Monday this week, shares of India-based Ajanta Pharma soared by over 5 percent in intraday trading as investors cheered the fact that no observations were issued during a regulatory inspection at its unit. “Our formulation facility at Dahej (in Gujarat) was inspected by US Food and Drug Administration (FDA) from April 3 to April 7, 2017. At the end of the inspection, no Form 483 was issued to us,” Ajanta Pharma said in a notification to the stock exchanges. FDA delivers a blow to Merck’s Januvia marketing plan    In 2015, Merck had come out with a massive 14,724-patient study where the data demonstrated that Type 2 diabetes patients could take its flagship DPP-4 drug — Januvia — without increasing their risk for cardio complications. DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin.  Merck wanted to use the findings of this survey in a label to help distinguish themselves from same-class rivals like Onglyza, which has risks. However, the FDA recently nixed the idea, handing the pharma giant a complete response letter (CRL). The CRL covered Merck’s blockbuster Januvia as well as its combos with metformin. However, Merck says it is reviewing the letter and will discuss next steps with the FDA. Teva’s US $ 3.5 billion buy pays off with FDA approval of Austedo   Last week, the FDA gave its nod for Teva’s promising drug deutetrabenazine, after putting it on hold ten months back due to certain suspicions regarding some metabolites found in patients. Teva had paid US $ 3.5 billion to acquire Auspex two years back. Teva’s deutetrabenazine is the first deuterated drug to bag an FDA approval. A deuterated drug is a drug where hydrogen has been replaced by deuterium. A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine or SD-809 (which had been developed by Auspex). The drug will be sold as Austedo. Due to the presence of deuterium, the drug breaks down more slowly in patients. This way physicians can give the drug less often and at lower doses and still manage great results. The drug is designed to regulate the levels of dopamine in the brain.  

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    #Phispers by PHARMACOMPASS
    13 Apr 2017
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    EU suspends drugs from Granules’ Indian facility where FDA had no concerns

    EU suspends drugs from Granules’ Indian facility where FDA had no concerns

    In October 2016, the US Food and Drug Administration (FDA) inspected a facility in India belonging to Granules India that manufactures pharmaceutical formulation intermediates (PFIs) and finished dosage forms (FDFs). The FDA had no observations. Three months later, Portugal’s health authority — INFARMED — inspected the same site and detected non-conformities in good manufacturing practices (GMPs).  According to an alert published on the INFARMED website, the observations were related to granulation and primary packaging of tablets in batches of drugs related to paracetamol and metformin supplied by Granules to Mylan, Bluepharma and Sandoz. The agency recommended the suspension and recall of certain batches from the market in Portugal. Last week, based on “General GMP Observations” of “regulatory partner(s)”, Health Canada placed Granules India’s facility located in Gagillapur (near Hyderabad) on its inspection tracker. Health Canada’s inspection tracker provides updates on the actions the regulator is undertaking to assess and manage potential risks arising from inspections of drug manufacturing facilities.  According to Granules, their facility in Gagillapur contributes over 50 percent to their revenues and “has the world’s largest PFI capacity along with an industry-leading batch size of six tons. In addition, the Gagillapur facility has one of the largest single-site finished dosage capacities in the world for their respective products.” In a recent interview, C. Krishna Prasad, managing director of Granules India, said there were no issues related to data integrity and INFARMED is scheduled to re-inspect the Gagillapur facility this week. Data integrity concerns at ACS Dobfar’s Italian facility   The FDA’s April 2016 inspection of ACS Dobfar’s operations in Brazil — Antibioticos do Brasil (ABL) — led to the issuance of a warning letter in December. Among other observations, the FDA investigators found that the filling zone for sterile injectable product was not sufficiently robust. Therefore, it didn’t protect the drugs being manufactured there (such as during the times when operators entered the final filling area). Almost immediately after the warning letter was issued, an inspection of the same facility by the Italian Regulatory Agency (AIFA) found it not-compliant for the manufacture of the active ingredient — Cephalexin Sodium Sterile. AIFA also recommended the suspension of the Certificate of Suitability issued for ceftazidime pentahydrate with sodium carbonate for injection. The inspectors found ABL failed to ensure a good level of maintenance and cleaning of the final crystallization area and there was a poor level of training, low knowledge and awareness of good manufacturing practices (GMP) along with lack of supervisory control. The non-compliance report also mentions that some non-authorized and fraudulent activities were stopped before inspectors entered certain manufacturing areas. Fraudulent activities were not limited to Brazil, as ACS Dobfar’s Italian drug manufacturing facility — FACTA Farmaceutici SpA — had FDA investigators uncover data-integrity violations during a January 2016 inspection.  The warning letter issued to FACTA mentions that for multiple lots of sterile drug product, where the original data showed failing results, the data reportedly showed passing results. The company was found storing original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. The analyst told investigators that original data was first recorded in the “unofficial” spreadsheet and later transcribed to an “official” form. Investigators also observed many copies of uncontrolled blank and partially-completed cGMP forms and also documented that employees at FACTA used paper shredders to destroy critical laboratory and production records. It is worth mentioning that FACTA’s EU GMP certification was renewed by the Italian regulators after an inspection that was conducted at the same time as the FDA inspection.  Data integrity concerns confirmed at Divi’s Laboratories in India   Divi’s Laboratories’ Unit-II situated in Visakhapatnam, Andhra Pradesh — one of the biggest manufacturing facilities for the major producer of active pharmaceutical ingredients (APIs) — was inspected by the US FDA from November 29 to December 6, 2016.  The regulators issued a Form 483 with five observations. While data integrity concerns had been widely reported in news media, Health Canada confirmed the violations by placing the company on its inspection tracker last week. FDA’s warning letter comes to haunt Dr. Reddy’s   South Korean biotech firm — Mezzion Inc — filed a suit for damages against Dr. Reddy’s in New Jersey state court alleging that it hid “significant deficiencies in its FDA cGMP practices” and misrepresented its compliance.  Mezzion has stated in its suit that “Dr. Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations” whereas the FDA issued a warning letter to Dr. Reddy's.  During an FDA inspection at Dr. Reddy's facilities in India, the FDA identified numerous data integrity violations and also uncovered a previously unknown and uncontrolled “Custom QC laboratory” (CQC), which engaged in a “practice of substituting repeat tests after failing results.” Mezzion further states: “Dr. Reddy’s misconduct was the sole reason given by the FDA to deny approval of Mezzion’s new drug application (NDA) for udenafil for the treatment of erectile dysfunction (ED)”.  As a result, Mezzion has incurred delays and was forced to seek new manufacturers and suppliers for udenafil and the udenafil finished product, in order to resubmit its udenafil New Drug Application (NDA) to the FDA for approval. FDA’s warning letters to manufacturers in UK and India   Porton Biopharma, UK: A warning letter was issued to the UK-based Porton Biopharma by the US FDA for manufacturing violations related to Erwinaze (asparaginase Erwinia chrysanthemi) — an orphan biologic which was developed by Porton and licensed to Jazz Pharmaceuticals. According to the warning letter, the FDA had previously performed an inspection of Porton’s facility in January 2015 and found similar concerns. The inspection between March 7 and 18, 2016, which triggered the warning letter, had FDA investigators observe continued deficiencies, including metal particles which penetrated a few batches of Erwinaze, another batch containing paper or cardboard fibers and a possible microbial contamination. While Porton believed that vial stoppers were the source of the metal scraps, the FDA investigators were not convinced. Erwinaze generated around US $ 43 million in the third quarter for Jazz Pharmaceuticals, accounting for more than 10 percent of the company’s revenues. CTX Life Sciences, India: The FDA issued a warning letter to CTX Life Sciences in India after making observations of rust, insects, damaged interiors, and/or drug residues in pieces of manufacturing equipment identified as “clean”. Investigators also found that the API were released without testing because the necessary laboratory equipment was out of order. While the company had decided to release batches “on conditional basis and as soon as UV maintenance issue rectified analysis shall be performed” the investigators could find no trace of the testing. Our view   Last week, in our compliance round up, we had reported the shredding of documents at Hetero Labs in India. And this week, similar issues have surfaced in Italy. It’s clear that corrupt practices of data integrity are spreading across the industry and are no longer confined to a region.  At the same time, while both European and US regulators reached a similar outcome on the compliance status of Antibioticos do Brasil, the divergent views at Granules India and FACTA Farmaceutici indicate the urgency for regulators to establish a consistent global evaluation standard for pharmaceutical manufacturing.  

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    #Phispers by PHARMACOMPASS
    02 Feb 2017
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    Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

    Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

    In less than three weeks, Donald Trump will assume office as the President of the United States. He has mentioned that he wants Medicare (a national social insurance program) to directly negotiate the price it pays for prescription drugs. Medicare provides health insurance to Americans aged 65 or more, who have worked and paid into the system through the payroll tax. It also provides health insurance to younger people with some disabilities or end-stage renal disease and amyotrophic lateral sclerosis. In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people. As we flag off the New Year, PharmaCompass provides insights into drug prices and prescription patterns in the US in order to help professionals make informed decisions. We believe that the cost of medicines in the US, which have been a subject of much public outcry and discussions in the recent years, will continue to be scrutinized during 2017.   Medicare data for 2014 Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers who collectively prescribed approximately US $121 billion worth of prescription drugs paid for under this program. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed (including original prescriptions and any refills), and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers).  The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not include information in cases where 10 or fewer prescriptions were dispensed.   Top Ten Drugs by Cost, 2014 [Most expensive for Medicare]    Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Sofosbuvir 109,543 33,028 7,323 $3,106,589,192 Esomeprazole Magnesium 7,537,736 1,405,570 286,927 $2,660,052,054 Rosuvastatin Calcium 9,072,799 1,752,423 266,499 $2,543,475,142 Aripiprazole 2,963,457 405,048 130,933 $2,526,731,476 Fluticasone/Salmeterol 6,093,354 1,420,515 281,775 $2,276,060,161 Tiotropium Bromide 5,852,258 1,211,919 253,277 $2,158,219,163 Lantus Solostar (Insulin Glargine) 4,441,782 972,882 224,710 $2,016,728,436 Sitagliptin Phosphate 4,495,964 789,828 190,741 $1,775,094,282 Lantus (Insulin Glargine) 4,284,173 787,077 223,502 $1,725,391,907 Lenalidomide 178,373 27,142 9,337 $1,671,610,362 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Average Cost Per Claim Adagen 13     $1,224,835 $94,218 Elaprase 100     $6,560,225 $65,602 Cinryze 1,820 194 196 $96,155,785 $52,833 Carbaglu 60     $2,901,115 $48,352 Naglazyme 129     $6,189,045 $47,977 Berinert 538 73 68 $25,685,311 $47,742 Firazyr 1,568 269 232 $70,948,143 $45,248 H.P. Acthar 9,611 2,932 1,621 $391,189,653 $40,702 Procysbi 314 41 47 $12,542,911 $39,946 Folotyn 15     $598,210 $39,881 Top Ten Drugs by Claims, 2014 [Most Commonly Used by Patients]   Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Lisinopril 38,278,860 7,454,940 464,747 $281,614,340 Levothyroxine Sodium 37,711,869 6,245,507 416,518 $631,855,415 Amlodipine Besylate 36,344,166 6,750,062 451,350 $303,779,661 Simvastatin 34,092,548 6,768,159 387,651 $346,677,118 Hydrocodone-Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Omeprazole 33,032,770 6,707,964 475,122 $529,050,385 Atorvastatin Calcium 32,603,055 6,740,061 419,327 $747,635,818 Furosemide 27,133,430 5,176,582 456,047 $135,710,772 Metformin HCl 23,475,787 4,509,978 364,273 $203,948,989 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Prescribers, 2014 [Most Popular with Doctors]   Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Hydrocodone/Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Ciprofloxacin HCl 7,253,018 4,926,835 568,201 $46,728,353 Amoxicillin 6,298,980 4,384,899 557,614 $31,193,739 Cephalexin 5,040,219 3,529,303 557,048 $36,987,401 Azithromycin 7,339,954 5,274,010 544,625 $70,699,119 Prednisone 11,032,986 4,505,821 536,108 $86,537,932 Tramadol HCl 14,250,227 4,272,724 515,816 $125,343,514 Sulfamethoxazole /Trimethoprim 4,833,758 3,090,944 500,790 $29,231,511 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 Amoxicillin/Potassium Clav 3,551,452 2,710,244 478,361 $61,713,432 The findings from CMS data The CY 2014 data represented a 17 percent increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services.  Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail drugs and US $ 128 billion (28.1 percent) was for non-retail drugs. The drug pricing process in the US is complex and reflects the influence of numerous factors, including manufacturer list prices, confidential negotiated discounts and rebates, insurance plan benefit designs, and patient choices. An IMS study found that across 12 therapy classes widely used in Medicare Part D, medicine costs to plans and patients in Medicare Part D are 35 percent below list prices. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! While the CMS does not currently have an established formulary, Part D drug coverage excludes drugs not approved by the US Food and Drug Administration, those prescribed for off-label use, drugs not available by prescription for purchase in the US, and drugs for which payments would be available under Parts A or B of Medicare. Part D coverage excludes drugs or classes of drugs excluded from Medicaid coverage, such as: Drugs used for anorexia, weight loss, or weight gain Drugs used to promote fertility Drugs used for erectile dysfunction Drugs used for cosmetic purposes (hair growth, etc.) Drugs used for the symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee Our view The Medicare program is designed such that the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do under other programs. For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D. If Trump administration kick starts direct negotiations on Medicare drug prices with drug companies, 2017 will surely turn out to be a year for the pharmaceutical industry to remember.   View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!    

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    #PharmaFlow by PHARMACOMPASS
    05 Jan 2017
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    FDA uncovers systemic data manipulation in China; India’s pharma lobby rubbishes report on pollution

    FDA uncovers systemic data manipulation in China; India’s pharma lobby rubbishes report on pollution

    This week, Phispers brings you news about Wockhardt and how its turnaround plans are going awry. There is also news about Novo Nordisk ending development of an oral form of insulin, data manipulation at Beijing Taiyang, the latest on treatment of high cholesterol and lots more.   Novo ends development of oral insulin, slashes long term growth forecast Novo Nordisk – the world’s biggest maker of insulin – slashed its long-term profit-growth forecast by half due to pressure on prices in its largest market – the US. The company is also ending development of an oral form of insulin, which has long been an unattainable dream for the global pharmaceutical industry. The Danish pharma company will be relying more on in-licensing early stage projects and working with external academic collaborators. Moreover, the company will focus more on diabetes and obesity adjacent conditions such as nonalcoholic steatohepatitis (NASH), cardiovascular disease and chronic kidney disease. In the US, Novo is experiencing payer difficulties that have resulted in disappointing performance of its modern insulins. The profit-growth estimate was trimmed to 5 percent from the 10 percent projected in February this year, as it lost key contracts. The company also saw some products being excluded from insurance-coverage plans as it promised large rebates in the US on 2017 prices. While Novo controls almost half the global market for insulins, the intermediaries who negotiate prices for insured patients in the US are opting for cheaper alternatives. Lower prices and escalating competition from biosimilars have dimmed prospects for Novo, Sanofi and Eli Lilly & Co. These pharma companies have been forced to deepen rebates and discounts.   Systemic data manipulation uncovered at Chinese API manufacturer The FDA has issued a warning letter to Beijing Taiyang Pharmaceutical Industry, a manufacturer of  active pharmaceutical ingredients such as diphenyhydramine hydrochloride, a commonly used ingredient in cold preparations. The warning letter states that FDA investigators “observed systemic data manipulation across the facility.” The investigators documented “unexplained deletions of laboratory test results, discovered that analysts repeated tests until they obtained acceptable results and that the company failed to investigate results that were out-of-specification.” The FDA investigators observed, through a window, a warehouse containing numerous drums bearing the company’s label. “When the investigators requested access to this warehouse, Beijing Taiyang’s staff barred them from entering the warehouse to examine the containers,” the letter adds. The following day, when FDA investigators were given access to the warehouse, they observed that a significant number of drums had been removed and were not available for inspection. The firm also relied on falsified and manipulated test results to support batch release and stability data. The FDA had placed Beijing Taiyang on its import alert list in April of this year.   Wockhardt’s compliance foibles haunt biotech startup Cempra Wockhardt’s ambitious turnaround plans received a serious setback last week when Cempra, a clinical-stage pharmaceutical company focused on developing antibiotics, learnt that the US Food and Drug Administration (FDA) may not allow  it to use an active pharmaceutical ingredient (API) produced by Wockhardt for approval and in the commercial use of its product Solithromycin. Two of Cempra’s products are in advanced clinical development. One of them – Solithromycin – has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia (CABP). Its applications for approval have been accepted by the FDA and the EMA. The setback to Cempra was the result of an in-person meeting held with the FDA in late October. The reason for the FDA decision was an import alert placed on a Wockhardt manufacturing facility in August 2016, several months after Cempra’s New Drug Applications (NDA) with Wockhardt had been submitted and accepted for review by the FDA. Cempra began an active dialog with the FDA to determine if the API produced at Wockhardt prior to the import alert was adequate for the NDA. While Cempra plans to provide the FDA with data from API sourced from another supplier, the news is a serious setback for Wockhardt’s ambitious turnaround plans to fix its compliance issues and become an antibiotic research powerhouse.   Sanofi-Regeneron’s potential blockbuster runs into manufacturing problems Last week, Sanofi and Regeneron Pharmaceuticals’ Sarilumab – a product in development for the treatment of moderately to severely active rheumatoid arthritis (RA)—received a setback. The two companies announced that the US FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for Sarilumab. The CRL refers to certain deficiencies identified during a routine good manufacturing practice (GMP) inspection of the Sanofi facility in Le Trait (France) where Sarilumab is filled and finished. Satisfactory resolution of these deficiencies is required before the BLA can be approved. However, Sarilumab performed extremely well in a head-to-head clinical study against AbbVie’s world best-selling drug, Humira. The manufacturing glitch was also the only negative in Sanofi’s better than expected earnings report which was released last week in which Sanofi announced that it would exit its European generics business in the next 12 to 24 months.    Cholesterol woes: Raising HDL can’t save you, and new drugs don’t work. Last year, two new drugs – Rephata and Praluent – that lower cholesterol, came on the market. Back then, analysts had estimated sales of more than US $ 3 billion a year. Working by blocking a protein called PCSK9, the drugs would clear out LDL, or bad cholesterol. While Sanofi and Regeneron launched Praluent, which is said to succeed where the traditional treatment – an inexpensive class of drugs called statins – fails, Amgen launched Rephata with a similar mechanism of action. A year on, doctors are reluctant to write prescriptions until they are sure of the benefits. Similarly, insurers are unwilling to pay for these drugs.  “These launches so far are close to, if not the biggest, wastes of development and commercial investment in recent industry history,” Geoffrey Porges, a biotech analyst at Leerink, an investment bank specialising in healthcare told STAT News. There was more bad news for patients suffering from high cholesterol. A study published this week has found little evidence that raising HDL, widely known as good cholesterol, protects against heart attacks and strokes. The study was published in the Journal of the American College of Cardiology. The drug industry has repeatedly failed to design a pill that might improve patients’ lives by increasing HDL. A decade ago, Pfizer spent more than US $ 800 million to get the HDL-boosting medication torcetrapib into late-stage trials, only to find that more patients died on the drug than on placebo. Roche was next to fail when its drug, dalcetrapib, came up short in a 16,000-patient trial in 2012. And last year, Eli Lilly shut down a study testing its evacetrapib on 12,000 patients after discovering that the drug had no effect on heart attack and stroke.   Pfizer fined for violating environmental laws in the US For the second time in recent years, Pfizer has been fined by the American authorities for violating the Clean Air Act at a manufacturing plant in Barceloneta, Puerto Rico. Pfizer was fined US $ 190,000 for failing to disclose information about hazardous chemicals that were used at the concerned plant. In early 2014, the Environmental Protection Agency (EPA) had found that Pfizer stored certain substances — in this case, ammonia and methylamine — that exceeded permitted amounts. This triggered a requirement to file a plan, which Pfizer failed to do and had to be fined. The substances were also used without properly being disclosed to the EPA.   Pharmexcil refutes report on drug-resistant bacteria Growing antimicrobial resistance (AMR) is one of the gravest threats to human health. Global deaths because of drug-resistant infections are projected to reach 10 million per year by 2050, with cumulative economic losses of US $100 trillion. A new report by campaigning organisation – Changing Markets – titled ‘Superbugs in the Supply Chain - How pollution from antibiotics factories in India and China is fueling the global rise of drug-resistant infections’ has revealed the presence of drug-resistant bacteria at pharmaceutical manufacturing sites in India. On-the-ground research and analysis of water samples found high levels of drug-resistant bacteria at sites in three Indian cities: Hyderabad, New Delhi and Chennai. Out of 34 sites tested, 16 were found to be harboring bacteria resistant to antibiotics, the report says. At four of the sites, resistance to three major classes of antibiotics was detected, including antibiotics of ‘last resort’, those used to treat infections that fail to respond to all other medicines. The report says antibiotics manufactured at or near these sites are being exported to United Kingdom’s National Health Service (NHS), French hospitals, and pharma majors including US distribution giant McKesson and French company Sanofi’s generics arm Zentiva.  The report cites Hyderabad-based Aurobindo Pharma as one of the worst offenders. However, Pharmaceuticals Export Promotion Council of India (Pharmexcil), which is part of India’s ministry of commerce, has termed the report as “fabricated” and “backed by vested interests” to malign the Indian pharma industry—the world’s largest producer of antibiotics. Aurobindo Pharma’s wholetime director M Madan Mohan Reddy is the chairman of Pharmexcil.   EMA probes Wanbury Pharma; French agency ANSM warns about fake GMP certificates Mumbai-based drug manufacturer Wanbury Pharma, which is one of the largest exporters of diabetes drug metformin, had been served a show-cause notice by the Maharashtra Food and Drug Administration last week for allegedly re-labelling its drugs that were being exported to Brazil, Mexico, Bangladesh and Pakistan. Wanbury has now come under the lens of the European Medicines Agency (EMA). The EMA is learnt to be investigating the allegations made by the Maharashtra FDA. Meanwhile, the ANSM (French agency for the safety of health products) has been informed of the use of several falsified GMP certificates under its letterhead for import and export activities of active substances. “Because of a recent increase in observed cases, the ANSM reminds stakeholders that the authenticity of GMP certificates should be checked on EudraGMDP Community database,” the ANSM website says.   Teva takes a shot at delaying generic Copaxone by writing to FDA Teva Pharmaceutical has submitted a document to the US FDA explaining the differences between its original multiple sclerosis drug Copaxone and the generic product being marketed by Momenta and Sandoz. In order to enter the market, the generic version of Copaxone requires both FDA approval and legal confirmation that it does not violate Teva's patent. According to analysts, the document is designed to delay the entry of a 40-mg generic version of Copaxone into the market (20mg generic Copaxone is already on the market). The document is also likely to undermine the confidence of FDA officials, leading to considerable delay in approval of the Momenta's generic drug for 40 mg Copaxone. Teva is currently in a court case concerning the patents that protect Copaxone against generic competition (for the 40mg version). However, most analysts believe Teva will lose the case, and that the generic product will be allowed to enter the market in 2017.   Former Valeant CEO and CFO being probed for accounting fraud In the US, an ongoing criminal probe into Valeant Pharmaceuticals is focusing on the extent to which the former chief executive officer – Michael Pearson – and former chief financial officer – Howard Schiller – allegedly hid a relationship with a specialty pharmacy – Philidor Rx Services – from insurers. Pearson was the key driver behind Valeant’s growth, which relied on price-gouging as a growth strategy. Pearson bought older medicines and hiked their prices manifolds to push up profits. Federal prosecutors are reportedly exploring potential charges of accounting fraud in connection with Valeant’s ties with Philidor Rx Services, a Bloomberg news report said. Valeant used its ties with Philidor to steer prescriptions and boost reimbursements for its medicines. For now, the probe is examining actions taken by Pearson and Schiller, though sources say others, such as Philidor executives, may also be charged.      

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    #Phispers by PHARMACOMPASS
    03 Nov 2016
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    Price gouging by Aspen in Italy; explosion at BASF; India acts on illegal Metformin exports

    Price gouging by Aspen in Italy; explosion at BASF; India acts on illegal Metformin exports

    This week, Phispers gets you news on illegal exports of Metformin in India, Hillary Clinton’s stance on price gouging, a report’s recommendations on reducing India’s dependence on Chinese APIs, Pfizer’s patent dispute case in the UK and more. Aspen Pharma fined for price gouging in Italy Last week, Italian antitrust authorities fined South Africa-based drug maker Aspen Pharmacare nearly US $ 5.5 million for halting supplies of several cancer drugs. This is being seen as a negotiating tactic designed to hike prices by as much as 1,500 percent. The products whose supplies were halted are: Leukeran 2 mg (chlorambucil); Alkeran 50 mg / 10 mg powder and solvent (melphalan); Alkeran 2 mg (melphalan); Purinethol 50 mg (mercaptopurine); and Thioguanine 40 mg (thioguanine). The price-gouging episode began after Aspen purchased the drugs from GlaxoSmithKline. It then began negotiations with the Italian Medicines Agency over pricing for the cancer medicines. According to the Italian Competition Authority, Aspen also used the threat of a shortage to achieve the prices it had sought, because the drugs temporarily disappeared from the market. It would be interesting to see the price rise in the US market for these products since Chlorambucil and Thioguanine have no generics in the United States. Clinton’s team had debated attacking FDA commissioner Califf, reveals WikiLeaks Around this time last year, the pharmaceutical industry had come under severe criticism for price gouging. And, if emails released by WikiLeaks are to be believed, Hillary Clinton’s campaign team had debated attacking Dr. Robert Califf, over his ties with various drug makers. Back then, Califf had been nominated to head the US Food and Drug Administration. Earlier this year, Califf got named as FDA commissioner.The email thread, pertaining to September 21-26, 2015, suggests how the issue had become a factor in her campaign. Through these emails, few members of Clinton’s team had weighed the pros and cons of picking a fight that would “fit into the larger themes we are trying to promote,” an email written by Clinton’s campaign press secretary had said.Similarly, a senior policy advisor had written: “We could certainly signal that we want someone willing to stand up to pharma.”Califf was the founding director of the Duke Clinical Research Institute, which conducts studies for companies. He has authored numerous papers with industry researchers. Two years ago, several large drug makers had partly supported his salary, while many others paid him for consulting work. These email exchanges took place amid rising outrage over price gouging, triggered by Martin Shkreli (founder and former CEO of Turing Pharmaceuticals). In September last year, Clinton had taken a jab at Shkreli through a tweet, for hiking the price of the antimalarial drug Daraprim by more than 5,000 percent. Clinton’s campaign staff had tweeted: “FYI – We have started the war with Pharma!!” Last month, Clinton issued a plan to contain prescription drug pricing. She proposed a federal panel of officials to determine if price increases for certain drugs are justified, authorize the federal government to directly purchase drugs through imports of competing drugs from other countries, and fine offending companies. India initiates action against two Metformin makers for illegal exports The Food and Drug Administration of Maharashtra, India has initiated action against two pharmaceutical companies – Pharmaceutical Products of India Ltd and Wanbury – for illegally rebranding and exporting a diabetic drug to Mexico, Brazil, Bangladesh and Pakistan.A part of the bulk drug – metformin hydrochloride – was being manufactured by Pharmaceutical Products of India, based in Tarapur. It was manufacturing 300,000 kilos of metformin hydrochloride for export every month. The company, however, did not have an export licence. On further investigation, the department found that the drug was sold to another firm – Wanbury in Patalganga – that had an export licence. The modus operandi was clear – Wanbury had an export licence and orders worth 650,000 kg per month of metformin HCL, but had a shortfall of 350,000 kg in manufacturing capacity, which was being fulfilled by Pharmaceutical Products of lndia. “Wanbury would just stick their labels on the drugs supplied by the latter without any quality checks,” said a Maharashtra FDA official. “Such unholy alliances can have disastrous effects on the country's drug export sector,” the official added. The companies have been charged under the Drugs and Cosmetics Act.  Industry watchers share how deregulation brings further risks Last week, in Speak Pharma, Bernard Plau, CEO of Akovia Consulting, talked about how fraud broke the trust of regulators. And this week, industry watchers – Dinesh Thakur and Prashant Reddy Thikkavarapu – share how deregulation by the Drug Controller General of India (DCGI) brings further risk, in an article published on The News Minute, titled “Deregulation of the pharma industry in the time of scandals’. Since the Ranbaxy scandal, there have been several other scandals in the Indian pharmaceutical industry, and these have involved big names such as Sun, Dr. Reddy’s, Wockhardt, GVK Bio and Alkem. These companies have come under scrutiny from foreign drug regulators. Thakur and Thikkavarapu say two kind of scandals have plagued the Indian pharma industry. The first is related to data fabrication by contract research organisations (CROs) that conduct bioequivalence (BE) testing. The second type involves drug companies indulging in fabrication of data during quality testing. “Instead of increasing regulatory scrutiny, the DGCI has been on a drive to reduce the regulation governing the Indian pharmaceutical industry in the name of ‘Make in India’,” they added.    Indian trade body study suggests ways of reducing dependence on Chinese APIs A study undertaken by trade body Assocham and market research firm RNCOS has highlighted how India’s overwhelming dependence on China for APIs has emerged as a worrisome area. The study has recommended steps that can help reduce imports of APIs from China – which stand at Rs 138.53 billion (US $ 2.08 billion), or 65.29 percent of the total API imports of Rs 212.16 billion (US $ 3.18 billion). “This is all the more disconcerting in the face of louder narrative against reducing trade gap with China, which is well over US $ 51 billion,” the study says.  One of the main reasons for huge API imports from China is the low cost of manufacturing and subsidy there. Moreover, India levies negligible import fee. “The import fees should be increased in line with other counterparts”, the paper said. The existence of multiple regulatory authorities for renewal of licences by India’s bulk drug manufacturers is also affecting production. “Therefore a single committee of various government departments should be formed to regulate the industry through a single window and audit of plants,” the study said. It also recommended developing mega parks for APIs across the country. More bad news for Teva as it mulls acquisition of Korea’s CelltrionLast week, PharmaCompass covered Teva’s misadventure in Mexico. Little did we know that more bad news awaited Teva. Just one month after Teva paid Regeneron US $ 250 million to get access to a new pain drug – fasinumab, the FDA has put its clinical trial on hold. The news comes at a time when Teva is said to be considering the acquisition of South Korea’s Celltrion in order to strengthen its biosimilar portfolio. Going forward, biosimilars are said to be a key element of Teva’s overall strategy. Teva and Regeneron’s fasinumab was being studied in a Phase IIb trial in chronic low back pain, among others tests including osteoarthrosis pain. The FDA is now asking the two partners for “an amendment of the study protocol” after seeing a case of adjudicated arthropathy (a disease of the joint) in a patient receiving high-dose fasinumab, who had advanced osteoarthritis.The two companies said they would now set about designing a pivotal Phase III study in chronic low back pain that specifically excludes patients with advanced osteoarthritis in the hope this was a one-off related to this disease. Pfizer loses appeal in a UK patent dispute case over Lyrica Pfizer lost an appeal in a UK patent dispute over Lyrica, one of the company’s top-selling drugs. The Court of Appeal upheld a 2015 verdict that had struck down key patent claims on Lyrica by Pfizer and cleared Allergan Plc’s Actavis generic unit of infringing it. The disputed patent covers the use of pregabalin for the treatment of pain. The business was bought by Teva this year. In 2015, Lyrica – which is also used to treat epilepsy – generated sales of US $ 4.8 billion for Pfizer. Pfizer has also sued Dr. Reddy’s Laboratories and Teva Pharmaceutical Industries over their generic pregabalin products. These days, Lyrica is used more for pain than for its original indication as a seizure drug. Pfizer now hopes to take its fight to the UK Supreme Court. “We maintain our belief in the validity and importance” of the patent, said Pfizer spokeswoman.  Explosion at BASF’s biggest plant in Germany kills twoOn October 17, an explosion and fire at chemicals maker BASF's production site in Germany is said to have killed at least two people and severely injured six. The explosion occurred at around 11.20 am local time, on a supply line connecting a harbor and a tank depot on the Ludwigshafen site. BASF is the world’s biggest chemicals company and the Ludwigshafen site, which is situated around 80 km south of Frankfurt, is the world's largest chemical complex, covering an area of 10 square km. The site employs 39,000 workers. Located on the Rhine river, the Ludwigshafen site receives many of its raw materials by ship. The company said it was unclear so far what caused the explosion. BASF is also unclear about the financial impact of the explosion.    

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    #Phispers by PHARMACOMPASS
    20 Oct 2016
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    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics.   GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field.  Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs.  FDA continues to race ahead with generic approvals  The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark  In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements.  Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million..  The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement. 

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    #Phispers by PHARMACOMPASS
    04 Aug 2016
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    Dr. Reddy’s faces penalties in the US; metformin found in American waters; Interpol seizes illicit medicines

    Dr. Reddy’s faces penalties in the US; metformin found in American waters; Interpol seizes illicit medicines

     This week, Phispers brings to you the latest news from the world of pharma where Merck was found lying under oath, Mylan’s “exceptionally large” drug price hikes reignited the price-gouging debate and data integrity issues surfaced in China. And, a lot more.Dr. Reddy’s acquires products from Teva; but faces penalties in the USThis has been a mixed week for Dr. Reddy’s Laboratories. The company has signed a deal with Israeli drug maker Teva to acquire a portfolio of eight abbreviated new drug applications (ANDAs) in the US for US $ 350 million. In April 2015, Teva had entered into a deal with Allergan to buy its generics products for US $ 40.5 billion, soon after it failed in its bid to buy Mylan. On the flip side, the US Consumer Product Safety Commission (CPSC) has sought civil penalties against Dr. Reddy’s for failing to report problems with packaging of several medicines. In a 4-1 vote held two weeks ago, CPSC said Dr. Reddy’s knowingly violated federal law as issues with child-resistant blister packs for five prescription drugs were not reported within the mandated 24 hours. The violations had occurred between 2002 and 2011.  After antibiotics in Chinese rivers, it’s metformin in American watersIn June last year, we reported on how antibiotics were found in the rivers of China. This week, a new study has found traces of the widely-used diabetes drug – metformin – and other medicines in dozens of streams throughout southeastern United States. The survey was done on 59 streams and it found an average of six different drugs. The findings suggest the cause of contamination was unrelated to discharges from wastewater treatment facilities. Metformin appeared in 89 percent of the samples and 97 percent of the sample sites. Researchers also found traces of tramadol (opioid); carbamazepine (anti-seizure drug) and Allegra (antihistamine). At some of the sample sites, the concentrations of these medicines are expected to affect aquatic life. There was also some good news about metformin this week. Research has suggested that metformin may exert a long-term protective effect against neurodegenerative diseases, including Alzheimer's and Parkinson's. Court overturns US $ 200 million jury award; says Merck ‘lied under oath’A federal judge in San Jose found Merck lied to a business partner and to the court. As a result, the judge threw out a patent infringement judgment Merck had won against Gilead Sciences. He also overturned a US $ 200-million jury award. This judgement is considered a landmark one, considering it involves Gilead’s blockbuster drug Sovaldi, a treatment for the hepatitis C virus, and Merck – the world’s fourth-largest drug company. “Merck's misconduct includes...misusing Pharmasset's confidential information..., and lying under oath at deposition and trial,” the federal judge, Beth Labson Freeman, said. This news comes at a time when a review by the US Food and Drug Administration (FDA) staffers questioned whether an experimental Merck drug is effective in treating Clostridium difficile, or C. difficile, the most common cause of infectious diarrhea in hospitals and nursing homes. Mylan’s ‘exceptionally large’ drug price rise brings pricing debate back in focusPrice gouging has been plaguing the global pharma industry for quite some time now. During the week, there was news about Mylan and Pfizer increasing prices. Over the last six months, Mylan has raised prices by more than 20 percent on 24 products. Meanwhile, Pfizer was in news for increasing the list prices of its medicines in the US by an average of 8.8 percent. This is the second time this year that Pfizer has substantially boosted prices for its prescription drugs. On January 1, Pfizer had raised prices by an average of 10.4 percent. Mylan boosted prices by more that 100 percent on seven other products. Wells Fargo analyst David Maris termed the price hikes as “exceptionally large.” In Europe, the high price of drugs is straining its cash-strapped health systems and depriving patients of the latest products. Ergo, the European pharmaceutical industry is considering a radical shift in the way it prices drugs so that companies are rewarded for the clinical benefit of treatments rather than the number of pills sold. An internal report prepared by the European Federation of Pharmaceutical Industries and Association has called for the removal of external reference pricing and placing curbs on parallel imports. Interpol’s Operation Pangea IX seizes US $ 53 million worth of illicit medicinesInterpol seized potentially life-threating drugs and goods, including fake cancer medication, substandard HIV and diabetes testing kits, counterfeit dental equipment and illicit surgical equipment, through its Operation Pangea IX. The operation involved targeting illicit online sale of medicines and medical devices. It involved 193 police, customs and health regulatory authorities from 103 countries. Operation Pangea resulted in 393 arrests worldwide and the seizure of more than US $ 53 million worth of potentially dangerous medicines. The operation was supported by private partners from the Internet and payment industries and saw the suspension of 4,932 websites selling illicit pharmaceuticals. India’s pharma industry growth dips to two-year lowThe impact of Indian health ministry’s gazette notification banning the immediate manufacture, sale and distribution of 344 fixed dose combination (FDC) drugs has begun to reflect in growth numbers. The Indian pharmaceuticals market’s growth this May was the lowest in two years, impacted by a drop in sales of FDC drugs, fresh price cuts and a lower than expected uptake, according to pharmaceutical market research company AIOCD PharmaTrack. For May, the pharmaceuticals market grew by 7.7 percent compared to 11.6 percent during the same month last year, reaching sales of Rs 994.76 billion (US $ 14.8 billion) over a 12-month period. India’s FDC market dropped 14.6 percent and is now valued at Rs 1.96 billion (US $ 29.1 million). Valeant may sell stake in Egypt’s largest drug company AmounValeant Pharmaceuticals International plans to step up its debt-reduction plans and is considering the sale of Egyptian drug maker Amoun Pharmaceutical. According to a report, Amoun may attract drug companies with an interest in expanding in emerging markets. Valeant is reportedly working with Goldman Sachs Group on the sale. Last year, Valeant had acquired Amoun’s holding company – Mercury Holdings – for around US $ 800 million, along with some contingent payments. Valeant’s intentions at the time were to use Amoun as a platform to further expand in the Middle East and Africa.  GMP problems roundup: Fresh cases emerge in China, India Beijing Taiyang Pharmaceutical Industry, a Chinese manufacturer of diphenyhydramine hydrochloride, a commonly used antihistamine, was placed on the FDA import alert list in April 2016. Last week, Beijing Taiyang was also placed on Health Canada’s Inspection Tracker List as the regulatory agency evaluated the risk the company’s products posed to patients. The primary reason given for the action was data integrity concerns. Akums Drugs & Pharmaceutical Limited is a major Indian contract manufacturer with nine facilities that mostly supply to the domestic market. Akums’ international expansion plans suffered a setback as its facility in Haridwar (India) failed its first EDQM (European Directorate for the Quality of Medicines & HealthCare) inspection.  The critical deficiency observed by the inspectors was the “lack of sterility assurance as there was insufficient evidence during validation to confirm that all ampoules in the load met the sterilizing conditions”. There were also deficiencies observed across all aspects of the quality management system. Akums’ failure is a setback for the Netherlands-based Nordic Pharma Limited for whom Akums was manufacturing progesterone injection 50mg/mL ampoules (Gestone). The inspection failure will result in the recall of four batches from the UK and Ireland and will most likely have Nordic Pharma retain their existing contract manufacturer, Hikma Italia SPA. 

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    #Phispers by PHARMACOMPASS
    16 Jun 2016
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    Phispers: India may ban animal-derived gelatin capsules; FDA Warning Letter trends, next-gen Nexium & more

    Phispers: India may ban animal-derived gelatin capsules; FDA Warning Letter trends, next-gen Nexium & more

    Here’s this week’s pharma news capsule – Phispers (Pharmaceutical Whispers) – which includes compliance issues at a Spanish vaccine manufacturer, positive news on diabetes drug metformin and Sanofi’s takeover bid for Medivation. Capsules in India may turn veg, as regulator plans ban on animal-derived gelatin First it was the ban on cow slaughter, then it was the ban of fixed dose combination (FDC) drugs and now the Indian drug authority is considering a proposal to replace the use of gelatin in capsules with cellulose. While a majority of capsules (around 95 percent) are made from gelatin, there have been concerns over the safety of animal derived gelatin in the past.  Drug used by 40 percent pork producers maybe carcinogenic; FDA takes step to withdraw itThe FDA took the first step toward rescinding its approval for the use of carbadox to treat swine because “the drug may leave trace amounts of a carcinogenic residue.” Carbadox, sold commercially as Mecadox, was first approved in the early 1970s. An estimated 40 percent pork producers rely on the medicine to treat and prevent disease in swine, as well as fatten the animals. The manufacturer of Mecadox – Phibro Animal Health – intends to request a hearing and refute the allegations. Metformin found safe by the FDA for patients with reduced kidney function There have been questions on how Metformin, one of the most commonly prescribed treatments for type 2 diabetes, should be used in patients with reduced kidney function. Last week, the FDA Concluded from the review of studies published in medical literature that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” A Dutch review had reached a similar conclusion earlier.  Pfizer spinout, RaQualia’s next-gen ‘Nexium’ getting ready for China launchA spin-out of Pfizer Japan, RaQualia has been evaluating tegoprazan (CJ-12420) as the next-generation version of AstraZeneca’s ‘purple-pill’, Nexium. While still in Phase III clinical trials, the product received a shot in the arm with RaQualia’s Korean partner CJ Group, reaching a development and licensing deal with China’s Shandong Luoxin Pharmaceutical Group. The deal, estimated to reap US $ 91 million in profit, will sell this new version of Nexium in China. Nexium treats gastroesophageal reflux disease. Multi-billion-dollar shareholder lawsuit against Pfizer revivedA federal appeals court in the US revived a class-action lawsuit accusing Pfizer of causing tens of billions of dollars of losses to shareholders by misleading them about the safety of its pain-relieving drugs – Celebrex and Bextra. The lawsuit began in 2004, and covers investors who bought Pfizer stock between October 31, 2000 and October 19, 2005. Compliance issues at Spanish vaccine manufacturerSpanish regulator has issued a recall of vaccines produced at an Inmunotek facility in Madrid and temporarily suspended the plant's manufacturing license after an inspection last month found critical issues with production and sterility at the company's San Sebastian de los Reyes site. FDA problems drag Ipca into more troubleIndia’s Ipca Laboratories had received a warning letter from the FDA for its API plants in February with inspectors citing data manipulation and falsification. Now, the warning letter has dragged Ipca into more problems. The shares of Ipca plummeted by over 14 per cent after an international financing organization – The Global Fund – decided not to allocate any volume of artemisinin-based combination therapy (ACTs) to the company in light of recent FDA warning issued to Ipca. Medivation snubs Sanofi’s initial takeover bidAmerican biopharmaceutical company Medivation Inc is learnt to have rebuffed a recent takeover bid from French drug maker Sanofi. Medivation, which focuses on treatments for hard-to-cure cancers, is seeking a higher price than what the initial proposals have indicated. If news reports are accurate, there are other suitors for Medivation too. Sanofi, on the other hand, is also open to making a hostile bid, a Bloomberg news report said. Are we entering an era of responsible drug pricing?KaloBios Pharmaceuticals Inc – a biotechnology company that was earlier led by controversial former drug executive Martin Shkreli – has vowed not to engage in aggressive pricing and to develop a transparent and 'responsible' pricing model for its products. KaloBios fired its chief executive Shkreli last December following his arrest on charges of securities fraud. Shkreli had sparked outrage last year when as the head of Turing Pharmaceuticals he had raised the price of a drug to treat a parasitic infection from US $ 13.50 to US $750. Let’s hope the KaloBios vow is a signal that the world of pharmaceuticals is entering an era of responsible drug pricing. FDA’s Warning Letter trends in FY2016In case you’re interested in learning how active the FDA has been halfway through their fiscal year, Barbara Unger has shared her compilation of warning letter trends and compared them with previous years.    

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    #Phispers by PHARMACOMPASS
    14 Apr 2016
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    FDA’s Drug Approvals in 2015: Novel Drugs & New Versions of Existing Drugs

    FDA’s Drug Approvals in 2015: Novel Drugs & New Versions of Existing Drugs

    Each year, the US Food and Drug Administration (FDA) approve hundreds of new medications. A small subset of approvals, classified as novel drugs, are considered to be truly innovative products that often help advance clinical care.  In 2015, the FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam).    This week, PharmaCompass focuses on the new dosage forms of existing drugs that got approved last year.   Modified blockbusters Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015:  Jadenu (deferasirox): With almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a tablet for use in a suspension. Novartis, the innovator, got approval in March 2015 for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has simplified daily treatment administration for patients with chronic iron overload. Nexium 24HR (esomeprazole magnesium): Also known as the Purple Pill, Nexium – Astra Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went  generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as Nexium 24HR. Last year, the FDA granted approval to the tablet form of the drug.  Iressa (gefitinib): AstraZeneca re-introduced Iressa in the US market in 2015. The FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets from the market, as post-marketing studies had failed to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted. Onivyde (irinotecan): Liposomal formulation of anti-cancer drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the treatment of patients with metastatic pancreatic cancer, sold under the brand name Onivyde.  Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.  Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines because of its high price (more than US $ 300,000 a year). Price concerns aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’.   Extended release versions Many of the approvals granted by the FDA last year were to extended release formulations (a pill formulated so that the drug is released slowly) of existing drugs. Kremers Urban’s extended release version of Methylphenidate capsules made headlines last year because of a reclassification of the drug by the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc. In addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus and Morphine Sulphate also received green signals for a market launch.   First generic opportunities Last year, PharmaCompass shared the names of some drugs which had no generic competition and were also not protected by patents. (Read: “Litigation Free, first generic opportunities list”). Deferiprone (a drug that chelates iron and is used to treat iron overload in thalassemia major) met the criteria. But it still has no generic competitor and is now available as a new dosage form. Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades without generic competition in the US. Albendazole is a medication used for the treatment of a variety of parasitic worm infestations. In 2015, patients were provided access to chewable tablets of Albendazole.   New combinations at work The FDA also approved multiple combination drugs where the individual active ingredients had been brought to market previously. Most of the combination drugs approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc. Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and Tradjenta (linagliptin) approved in 2011, were combined and the combination drug product Glyxambi was approved in 2015. Another combination of empagliflozin, with metformin – Synjardy – was also approved in August last year. Lesser known companies also got combination drugs approved.  UK-based development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine polistirex. Similarly, US-based biopharmaceutical startup, Spriaso LLC, also working in the cold and cough therapeutic area, got an extended release tablet containing codeine phosphate and chlorpheniramine maleate approved. Symplmed, a company which is developing various forms of Perindopril, got approval for Prestalia (a combination of perindopril arginine and amlodipine besylate) for the treatment of hypertension. Our view Each year, the FDA approves several pharmaceutical drugs in order to improve patient care; and often versions of these drugs are marketed and distributed across the globe. PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy. Accelerate your drug development PharmaCompass has also launched the Drug Development Assistance tool on its platform. Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate the various drug products approved in the United States.  

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    #PharmaFlow by PHARMACOMPASS
    14 Jan 2016
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    Merck’s top-selling diabetes drug less effective than a match-stick size implant

    Merck’s top-selling diabetes drug less effective than a match-stick size implant

    A tiny match-stick size implant, being developed by Boston-based biopharmaceutical startup – Intarcia Therapeutics – was found more effective in reducing blood sugar and body weight than Merck’s top-selling diabetes drug Januvia (sitagliptin). In a year-long study on 535 patients, Intarcia’s implant – ITCA 650 – led to an average weight loss of 4 kilograms, compared to a loss of 1.3 kilograms in patients taking Januvia. The device reduced blood glucose (measured through HbA1c or glycated haemoglobin test) by 1.5 percentage points, compared with 0.8 percentage point for Januvia. Different drugs and delivery systems for the management of diabetes Initial therapy for the management of type 2 diabetes is almost always metformin and lifestyle interventions. Due to the progressive nature of the disease, pharmacological agents in addition to metformin are required for successful management. There are various treatment options available today. And that’s why choosing the next course of action can be quite challenging for physicians.Two types of drugs – Glucagon-like peptide-1 (GLP-1) receptor agonists and Dipeptidyl peptidase-4 (DPP-4) inhibitors, which act in distinct ways to regulate blood sugar levels – have become the fundamental treatment options before physicians. GLP-1 receptor agonists enjoy the “higher status” due to greater reductions in blood sugar and weight. While DPP-4 inhibitors can be taken in pill-form, GLP-1 receptor agonists have (so far) only been available as injections.Sitagliptin, sold by Merck under the brand names Januvia and Janumet (sitagliptin and metformin), had a combined sales of US $ 6 billion in 2014 and are the top selling drugs in the DPP-4 inhibitors drug class. In comparison, AstraZeneca’s GLP-1 receptor agonist – exenatide – generated total sales of about US $ 767 million in 2014, doubling their 2013 sales. The sales of GLP-1 receptor agonists continue to increase.AstraZeneca sells two version of their GLP-1 receptor agonist – Byetta (exenatide twice a day) and Bydureon (exenatide once a week). ITCA 650, the avant-garde delivery system, could disrupt diabetes management Intarcia’s drug under development – ITCA 650 (continuous subcutaneous delivery of exenatide) – works in a manner similar to AstraZeneca’s Bydureon.  The only difference is that unlike an injection, it is released very slowly over time. The high-tech delivery system is a matchstick-sized device consisting of a cylindrical titanium alloy reservoir placed under the skin. Water from the extra-cellular fluid is used to drive an osmotic pump, which is designed to release the drug (exenatide) in small amounts over the course of the year.This means that patients don’t have to worry about forgetting to take their pills!The implant takes under five minutes to be placed in the body at a physician’s clinic. Intarcia has run four final-stage trials covering 5,000 patients. Intarcia plans to apply for the U.S. regulatory approval in the first half of 2016. The Boston-based company has a partnership with French drug-maker, Les Laboratoires Servier SAS, to develop and commercialize the product outside the U.S. and Japan. A new era for drug-device combosTransdermal patches, drug-eluting stents, inhalers, surgical meshes with antibiotic coatings are among the many approved drug-device combinations used in novel ways to deliver medicines. In fact, drug-device combinations have been around for years. As per estimates, the global market for drug-device combos is expected to grow from US $ 66 billion in 2012 to US $ 115 billion by 2019.In 2002, the FDA set up the Office of Combination Products (OCP) specifically to handle the convergence of drug and device technologies. However, since drugs and devices are managed by different regulatory pathways, uncertainty over how the FDA will review the application has made launching a drug-device combination challenging. In order to “eliminate the high level of uncertainty in approval standards”, the Combination Product Regulatory Fairness Act of 2015 was introduced before the U.S. legislators last month. While concerns still remain on how the FDA will approve applications, the government support is an encouraging sign.  Our viewWhenever diagnosed with fever or the flu, we don’t think twice before popping a 500 mg pill comprising active pharmaceutical ingredients. In comparison, AstraZeneca’s Bydureon requires patients to inject 2 mg of exenatide once a week to manage type 2 diabetes. With patients requiring only 100mg of the active ingredient on an annual basis, Intarcia’s revolutionary match-stick sized implant offers significant benefits to patients suffering from type 2 diabetes.  Factors like an emerging supportive regulatory landscape, increasing incidence of diabetes (29 million Americans aged 20 years and above had type 2 diabetes in 2012) and the effectiveness of the drug when compared with Januvia, prove that you will definitely hear a lot more about Intarcia in times to come. 

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    #Phispers by PHARMACOMPASS
    03 Sep 2015
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    FDA approved first 3D printed drug is no fad but a technology you can easily develop

    FDA approved first 3D printed drug is no fad but a technology you can easily develop

    Recently the USFDA approved Aprecia Pharma’s SPRITAM® levetiracetam – a drug for epilepsy treatment manufactured by 3D printing. This approval should encourage other players to pursue drug development with renewed vigor. Last week saw a revolutionary approval from the US Food and Drug Administration (USFDA). For the first time, the USFDA approved a drug manufactured by three dimensional printing (3DP) – Aprecia Pharmaceuticals received the USFDA approval of epilepsy treatment SPRITAM® levetiracetam. Leveitracetam was first approved in 1999.   Revolutionary formulation & rapid delivery system Aprecia gained the exclusive licence to 3DP technology from MIT in the late 1980s, and by 2007 it began developing its proprietary ZipDose technology. But SPRITAM is revolutionary, not just because it is 3D printed, but for other reasons as well. SPRITAM® is a porous formulation that rapidly disintegrates with a sip of liquid. The dispersion is significantly superior to a conventional over the counter fast-melt tablet (watch the video: https://www.aprecia.com/zipdose-platform/zipdose-technology.php). In fact, the drug is designed to dissolve in the tongue (rather than swallowed as a whole). The patient experience is enhanced since SPRITAM delivers an extremely high drug load, up to 1,000 mg in a single dose. No measuring is needed as each dose is individually packaged, making it easy to carry this treatment on the go.   3D printers are not even expensive For those not familiar with 3DP (or additive manufacturing), it is a process used to make a three-dimensional object without the use of dies, molds or machining. Instead, additive processes are used, in which successive layers of material are laid down under computer control (watch the video: https://www.youtube.com/watch?v=G0EJmBoLq-g). These objects can often be of virtually any shape or geometry, and are produced from a 3D model or another electronic data source. A 3D printer is a type of industrial robot, and can range from small scale consumer models to large factory units. Now for the moot question – why are pharmaceutical companies not developing drugs with 3D printing? In fact, 3D printers are inexpensive, and the ingredients used to produce the drugs are the same that are currently being used and there are multiple candidates, other than those Aprecia is working on which would benefit from this technological revolution. Making 3D printed drugs is really not that complicated or expensive. A recently published paper by researchers at the University College of London (UCL), “Effect of geometry on drug release from 3D printed tablets” produced different shaped tablets using 3D printing which would be otherwise difficult to produce using traditional methods.   Simple guide to make 3D printed drugs The researchers simply purchased water-soluble PVA filament from MakerBot (not currently available but other PVA filaments are available on Amazon for under US $ 50), along with widely used pain reducer and fever reliever, Paracetamol (also known as Acetaminophen) and salts. They cut the filament into small pieces (approximately 2mm in length), basically turning the spool of filament into pellets. This was followed by mixing in the Paracetamol, and extruding the mixture from a Filabot filament extruder (it costs US $ 949) at 180 degrees C. What came out of the printer was a 3D printed drug.   PharmaCompass’ potential candidates for 3DP Staying focused on opportunities where an extremely high drug load – up to 1,000 mg – has to be delivered in a single dose we ran a search on the PharmaCompass database to find a few potential candidates for 3D printing.   Drug Name Therapeutic Indication Aminocaproic Acid Bleeding disorder treatment Sucralfate Ulcer medication Cefadroxil Antibiotic Colestipol Hydrochloride Lipid lowering  Metformin Hydrochloride Diabetes Methenamine Hippurate Urinary Tract Antiseptic Ranolazine Chronic Angina Valacyclovir Hydrochloride Viral Diseases Icosapent Cholesterol reduction   In addition to these products, there are multiple other possibilities which can get created by producing combination drugs using 3D printing.   Overcoming the challenges of slow 3D printing With nearly three million people in the United States diagnosed with active epilepsy, Aprecia Pharmaceuticals’ revolutionary form of Levetiracetam clearly has a very large market need to address. However, the problem with 3D printing is that it is exceptionally slow when compared with conventional production methods for tablets. Anticipating the problems, Aprecia Pharmaceuticals announced on Feb. 23, 2015, that the company will open a new manufacturing facility in Ohio that will use its powder–liquid three-dimensional printing (3DP) technology.  With plans to invest $25 million in a 190,000-ft2 facility, the new facility will be in addition to the company's existing manufacturing and R&D facility in New Jersey.   Disrupting healthcare in 3D In the healthcare industry, 3D printers are used by dentists to create replicas of jaws and teeth as well as some finished dental implants and orthopedic surgeons have tested them to make customized hip replacements. In 2012, a two-year-old girl in Illinois, born without a trachea, received a windpipe built with her own stem cells. British scientists have also used 3D printing to create personalized replica models of cancerous parts of the body to allow doctors to target tumors more precisely.   Our View The current way of consuming tablets can definitely undergo a serious overhaul. With 3D printing technology rapidly evolving and already inexpensive, there is little reason for the industry not to pursue this area of drug development with greater vigor. In addition, if we can measure our blood sugar levels using diagnostic kits at home, is it unrealistic to imagine a day when we’ll start printing our own medicines in 3D?   

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    #Phispers by PHARMACOMPASS
    13 Aug 2015
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    Novartis’ plant shut down creates urgency to find alternatives to Chinese APIs

    Novartis’ plant shut down creates urgency to find alternatives to Chinese APIs

    With Novartis shutting two plants in Germany and one in India by 2016-end, the global reliance on China for bulk drugs has increased even further, raising serious concerns over safety, supplies and national security. Which plants? Last week, Novartis announced it will be shutting three plants of its generic business – Sandoz – by the end of 2016. The first plant is in India and the other two are located in Germany, in Gerlingen and Frankfurt.  Frankfurt, manufacturer of a key antibiotic intermediateThe Frankfurt plant is where Sandoz manufactures 7-ACA (7-aminocephalosporanic acid), the core chemical structure (building block) for producing a whole host of cephalosporin antibiotics. The reason given for closure -- prices of the cephalosporin active pharmaceutical ingredients (APIs) and intermediates have collapsed as Asian competitors have dumped excess capacity on the market. The shutdown of the Frankfurt facility means that the global reliance on China for APIs, used to produce antibiotics (such as cephalosporin) and especially 7-ACA, will increase only further. Chinese APIs are already a security threat for India India produces a third of the world's medicines, mostly in the form of generic drugs. However, according to an Oct 2014 report by a Boston Consulting Group (BCG) and Confederation of Indian Industry (CII), more than 90 percent of the key raw materials (intermediates and APIs) that go into making at least 15-odd essential drugs come from China.The drugs listed include the most commonly used painkiller such as paracetamol, aspirin; antibiotics such as amoxicillin and ampicillin, cephalexin, cefaclor, ciprofloxacin, ofloxacin, levofloxacin; first line diabetes drug metformin; and antacid ranitidine. There are no domestic producers left for many drugs such as penicillin-G, and its derivative 6-aminopenicillanic acid, or 6-APA.Since India is still receiving a large quantity of 7-ACA from Germany (confirmed by the import statistics available on the PharmaCompass database),  7-ACA and its derivatives were not mentioned in this report.As per news reports, the Indian government is now worried about over-dependence on imports from China. "Any deterioration in relationship with China can potentially result in severe shortages in the supply of essential drugs to the country. Additionally, China could easily increase prices of some of these drugs where it enjoys virtual monopoly," said Bart Janssens, partner, BCG, in a news report published in The Economic Times. Recognizing the national healthcare security challenge facing India, the Department of Pharmaceuticals (DoP) has decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients.’ As part of this initiative, the Indian government intends to build cluster parks to boost India’s self-reliance on Chinese imports. Quality, environmental concerns over Chinese AntibioticsChinese supplies of 7-ACA have been plagued with multiple issues in the past. In 2012, for instance, several Chinese drug companies were accused of manufacturing 7-ACA using contaminated ‘gutter oil’, instead of more expensive soybean oil. Gutter oil is reprocessed oil manufactured from waste oil and animal fat collected from restaurants’ fryers, drains, grease traps and slaughterhouses. Chinese restaurants can get through a lot of cooking oil and this waste oil fuels a highly profitable gutter oil black market as there are few other outlets, such as biofuel production, for this by-product.Similarly, antibiotic pollution in the rivers of China is a serious cause of concern for the Chinese. Our previous analysis, “Antibiotic resistant superbugs: deadlier than cancer and closer to you than you think” provides a detailed overview regarding the challenge being faced. However, with growing focus on antibiotic pollution in China, a shutdown of factories failing pollution norms would be a severe setback for the global antibiotic supply chain.  In addition to these challenges, quality concerns have been raised during international regulatory inspections of some of the leading antibiotic producers in China, like Zhuhai United and North China Pharmaceutical Company. South African stock outs of essential drugs a global concernThe outcomes of these challenges are already being felt in countries such as South Africa which are facing an acute shortage of critical drugs. According to a report published in Groundup, drug shortages in South Africa’s health facilities have become a crisis. The story mentioned the situation in a hospital (Stanger Hospital) in Ilembe District KwaZulu Natal, where 200 products were out of stock. These included various doses of morphine, some antibiotics and antiretrovirals, especially paediatric ones, used to treat HIV. “About a hundred patients per week are going without ranitidine which prevents stomach ulcers. Several Ilembe facilities are even out of stock of paracetamol tablets,” the Groundup report said. There are multiple reasons for the drug stock outs. However, unprofitability because old, off-patent products are being sold by manufacturers at prices very close to the cost of production has played a major role. Firms are abandoning such products and seeking higher return alternatives. In addition, due to quality failures suppliers are unable to provide lifesaving medications to the South African population.  Our ViewThe problems of stock outs and quality concerns in South Africa can easily expand across the world and can’t be addressed until the global pharmaceutical industry reduces its reliance on China for bulk drugs and intermediates. It remains to be seen if the threat to the global supply chain will make Novartis reconsider its decision or drive a national government to buy the Frankfurt facility. 

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    #Phispers by PHARMACOMPASS
    30 Jul 2015
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    Will data integrity concerns on clinical trials done at GVK Biosciences go beyond Europe?

    Will data integrity concerns on clinical trials done at GVK Biosciences go beyond Europe?

     Over 700 commonly used generic medicines were recommended for suspension by the European Medicines Agency (EMA) based on data integrity concerns, over clinical studies conducted at GVK Biosciences in Hyderabad, India.What will be the global fallout of the European decision? The European decision has impacted products from companies such as:Abbott Laboratories, Accord Healthcare (Intas), Actavis, Alembic, Apotex, Betapharm (Dr. Reddy’s), Brown & Burk UK, Fair Med Healthcare AG, Glenmark, Lupin, Micro Labs, Mylan, Orion Corporation, Ranbaxy, Ratiopharm, Sandoz, Sanofi-Aventis, Stada, Teva, Torrent, Wockhardt, Zydus… and many, many more.The original recommendation of suspending some of the medicines made in January 2015, was an outcome of an inspection of GVK Biosciences’ site in Hyderabad (GVK BIO is a Clinical Research Organization- CRO) by the French medicines agency (ANSM) through the EMA. The EMA stated in their official release: “The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site.” 1000 drugs reviewed// 700 rejectedWhile over 1,000 pharmaceutical forms and strengths were reviewed at the GVK site, over 300 of them had sufficient supporting data available from other sources. As a result, these medicines were allowed to remain on the market in the EU.However, for the over 700 other medicines, the EMA after its second review, maintained its previous recommendation of January 2015, to suspend medicines, where no additional supporting data from other studies was available. Only one exception after that second review was spared from suspension, as the company was able to address the EMA’s concerns: it was Bivolet Nebivolol (5 mg tablets/ marketing authorisation holder: Neo Balkanika EOOD).While the agency noted that “there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. Some of these medicines may remain on the market” if they are of critical importance for patients. However, the recommendation will now be sent to the European Commission for a legally binding decision, which will apply to Member States regardless of the decision taken in the interim period.The updated list of medicines for which, the CHMP (Committee for Medicinal Products for Human Use) recommends suspension, is available on the EMA website. Companies are given 12 months to submit additional data. The potential global impact of the European suspensions?The GVK Biosciences scandal is almost as severe in magnitude and impact, as the data falsification concerns, which were discovered at Ranbaxy (Katherine Eban’s stunning investigation in Fortune, “Dirty Medicine” covers this extensively). One of the main promoters of GVK Biosciences is Mr. D.S. Brar who was CEO & Managing Director of Ranbaxy from 1999-2004. The impact of GVK Biosciences’ misdeeds is already being felt on new product launches. Mylan recently withdrew its European application for generic Abilify (aripiprazole) (2014 sales US$6.2x billion) citing “identification of major GCP issues (Good Clinical Practices).” What about the impact on the US market?In 2010, FDA discovered data integrity violations, which bankrupted clinical research organization, Cetero Research/PRACS. Based on the Cetero findings in the United States, the EMA suspended seven drugs. Now it remains to be seen, how the FDA will handle the data integrity concerns found in Europe since products like repaglinide & candesartan cilexitil (Mylan), levetiracetam (Dr. Reddy’s), clonazepam (Sandoz), metformin hydrochloride (Actavis), tacrolimus (Panacea Biotech) all have U.S. FDA approvals.  Leading GVK Biosciences’ defense is the Indian government, who warned last month that if the European Union does not reconsider their decision, it may go to the World Trade Organization. The Indian government’s position is based on an appeal by GVK Biosciences, which made the “Indian government set up a panel of experts last year to investigate the matter and found no manipulation”, GVK Biosciences CEO Manni Kantipudi told Reuters.However, globally reputed GMP expert, Lachman Consultants, believes that the GVK Bioscience episode “could potentially impact data integrity, similar to the Cetero/PRACS case”.It’s clear for us that this is not the end of the story… 

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    #Phispers by PHARMACOMPASS
    28 May 2015
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    Diabetes: Which New Drug is the Safest? FDA Issues Safety Warning on oral Antidiabetic Blockbusters.

    Diabetes: Which New Drug is the Safest? FDA Issues Safety Warning on oral Antidiabetic Blockbusters.

      Recently launched type 2 diabetes molecules, canagliflozin, dapagliflozin, and empagliflozin, were served a deadly blow as the FDA recently issued a safety warning regarding their use, leading to a potential life-threatening condition. As almost all diabetes products have some side effect or the other, we are wondering, which next generation diabetes drug is the safest? The recent warning of the U.S. Food and Drug Administration (FDA) says that: “type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition, where the body produces high levels of blood acids called ketones, that may require hospitalization”.  The FDA warning is a severe setback as it limits the options available to reduce blood sugar without the need for needles. Ketoacidosis, typically affects type 1 diabetes patients, but patients using these new molecules were type 2 diabetes and have developed ketoacidosis. All of the cases highlighted by the FDA involved people with type 2 diabetes, even if the condition manifested itself slightly differently than in patients with type 1 diabetes. These drugs, are also known as SLGT2 inhibitors. They have been on track for blockbuster sales and are sold under different brand names. Table// Brand names for SLGT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin): Company Name Single Ingredient Fixed-dose Combination Johnson & Johnson Invokana® (canagliflozin) Invokamet® (canagliflozin and metformin) AstraZeneca Farxiga® (dapagliflozin) Xigduo XR® (dapagliflozin and metformin) Boehringer Jardiance® (empagliflozin) Glyxambi® (empagliflozin and linagliptin) Blockbuster sales: Johnson & Johnson, the first to get approval for their SGLT2 inhibitor (canagliflozin) in the United States, reported in 2015 first quarter sales of $278 million, almost triple of their sales for the same period last year. The quarter-on-quarter growth was almost 40%! AstraZeneca, on the other hand, had to contend with a dapagliflozin drug stock out in Canada “due to higher than anticipated demand”. Actually, the overall sales estimates, for this class of drugs, have been variable with some analysts believing the annual sales will be US$2 billion, while others, expect them to reach US$5 billion. Adverse side effects: Despite these success stories, SGLT2 inhibitors have had a bumpy ride in the approval process with potential cancer risk, leading to the rejection of the initial dapaglifloxin application by the FDA. This category of molecules have also been linked to increased rates of genital and urinary tract infections, along with kidney damage and cardiovascular issues.   So who will benefit? All this bad news on SGLT2 drugs could be positive for another class of anti-diabetic molecules called DPP4 inhibitors. Merck & Co’s Januvia® (sitagliptin) and Janumet® (sitagliptin and metformin) dominate this category of products with almost $6 billion in 2014 sales. In addition this year, Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was not the case for other DPP4 inhibitors like AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin). While Merck’s Januvia has its own set of concerns (there have been reports of acute pancreatitis), the risks compare mildly when associated with other new anti-diabetes drugs. For Takeda’s other diabetes drug, Actos® (pioglitazone), lawsuits related to cancer risks drove the company to its first annual loss in six decades. They paid a settlement of $2.4 billion last month. While Actos® continues to remain on the market, safety concerns will impact the future sales of diabetes medicines, as they all battle one of the biggest epidemics challenging public health.  

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    #Phispers by PHARMACOMPASS
    21 May 2015
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    Merck vs Merck: A ‘Mercky’ tale

    Merck vs Merck: A ‘Mercky’ tale

    It doesn’t help that the company, which calls itself Merck in the United States isn’t allowed to do so in other parts of the world, because the other Merck is called Merck. Confused? Well you wouldn’t be the only one! Merck is the world’s oldest pharmaceutical and chemical company, which has done business for almost 350 years. Since almost everybody in a chemistry lab has used a Merck product at some point of time, and now that Sigma Aldrich also belongs to Merck, we thought it would be worthwhile to create a simple comparison chart to better understand the two companies:   Merck & Co., Inc. Merck KGaA Website www.merck.com www.merckgroup.com  Logo      Headquarter Kenilworth, New Jersey, United States Darmstadt, Germany Founded 1891, by George Merck, as an American subsidiary of German Merck 1668, by Friedrich Jacob Merck The Split Owing to World War I, Merck & Co. was expropriated by the U.S. government in 1917 Name in the US and Canada Merck EMD Millipore (Emanuel Merck Darmstadt) Name in the rest of the World MSD, Merck Sharp & Dohme or  MSD Sharp & Dohme Merck Total Sales (2014) $42 Billion €11.5 Billion Employees 70,000 39,000 Merger & Acquisitions Sharp & Dohme, Inc. Schering-Plough Idenix Pharmaceuticals Cubist Pharmaceuticals OncoEthix Medco Containment Services Inc. Millipore Corporation Serono SA Sigma-Aldrich AZ Electronic Materials SA Major Products Januvia®, Janumet®, Zetia®, Vytorin®, Gardasil®, Remicade® Rebif®, Erbitux®, Gonal-f®, Concor®, Glucophage®, Euthyrox® Recent facts of Confusion: 2011 German Merck KGaA used to have Facebook page:http://www.facebook.com/merck, but one day found U.S. Merck & Co. there instead. As Merck KGaA had an agreement with Facebook, the matter reached the courts . Eventually Facebook admitted their mistake and let the German Merck resume its place at www.facebook.com/merck. U.S. Merck & Co. now sits at http://www.facebook.com/MerckBeWell. 2014 Protestors from the group STOPAIDS (a network working on how to secure an effective global response to HIV and AIDS) reached the offices of Merck KGaA in London, when protesting Merck’s “campaign to delay South Africa’s proposal to allow low-cost copies of patented drugs.” The only problem: the protestors were targeting U.S. based Merck & Co instead of German Merck… 2014 Bloomberg headline “Bayer to Buy Merck Consumer-Health Unit for $14.2 Billion” resulted in Merck KGaA issuing a same day clarification “Merck to Keep Consumer Health Business” since the Bloomberg article was referring to the U.S. Merck & Co! 2015 Even Merck KGaA CEO Karl-Ludwig Kley admits that his company bears some fault in allowing the situation to get to this point: “over many decades we underinvested in our brand,” he told the Financial Times: “we need to make people more aware of the fact there are two Mercks.”   RadioCompass just thought it was worth helping Mr Kley out with this complilation! 

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    #Phispers by PHARMACOMPASS
    13 May 2015
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