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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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29 Apr 2020

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Teva may get foreign CEO; FDA warns drug makers to check water systems

This week, Phispers brings you an update on Teva’s continuing woes that include fines, plant closures and layoffs. With Laurus Labs’ Vizag unit clearing the US FDA inspection, we evaluate what Laurus’ expansion plans could mean for Mylan. And then there is some bad news on Pfizer, Amgen and AbbVie. While arthritis patients in Scotland sued Pfizer for its anti-inflammatory painkiller, Amgen suffered a setback over its osteoporosis drug and AbbVie’s Humira lost a patent battle. Read on. Teva fined in India; may get foreign CEO; to shut down Hungary plant and layoff 500 Teva’s woes are continuing unabated. On Monday, India’s National Green Tribunal (NGT) slapped a fine of US$ 23,139 (INR 1.5 million) on Teva API India Limited for discharging untreated effluents into the Bagad river. The tribunal found the discharge from the sewage treatment plant of Teva API’s Gajraula-based plant in Uttar Pradesh to be below the permissible standards. Last month, the NGT had ordered closure of 13 industrial units in Uttar Pradesh, including the Gajraula plant of Teva API. Globally, the Israel-based generic giant may get a foreigner as its CEO. During a call with analysts recently, Teva’s chairman Sol Barer said: “We are looking around the world for the best candidate.” Teva’s CEO Erez Vigodman had stepped down in February this year. The company’s CFO Eyal Desheh has said he is resigning at the end of June. Teva’s Israeli board members are demanding that an Israeli be appointed CFO if the CEO is a foreigner. And then there is more trouble for Teva in Hungary. Last year, PharmaCompass had reported on Teva’s newly built sterile manufacturing facility in Godollo, Hungary, the issues highlighted by the FDA in its warning letter and the product recalls from this unit. Well, Teva is now winding up its sterile injectables plant in Godollo, and laying off 500 workers in the next few months. The plant had halted production last year after the FDA found manufacturing shortcomings. According to a Reuters report, Teva plans to close down or sell the Godollo plant by 2018-end. The company says its plans do not affect its other two Hungarian plants in Debrecen and Sajobabony. However, Teva isn’t the only one cutting jobs. Novartis announced it will cut 500 traditional production and development roles in Switzerland and another 250 job cuts are planned in the United States. This is part of Novartis’ global restructuring efforts. As G20 meets on antibiotic resistance, DSM wins an amoxicillin patent battle in India Last week, health ministers of the G20 leading economies met for the first time and agreed to work together to combat issues such as a growing resistance to antibiotics. They also agreed on implementing national action plans by the end of 2018. According to the member countries, infectious diseases were spreading more quickly than before due to increased globalization. The 20 nations pledged to strengthen health systems and improve their ability to react to pandemics and other health risks. The results of the meeting will provide key inputs for a G20 leaders’ summit in Hamburg in July. A report last year found that newly resistant strains of bacteria were responsible for more than 25,000 deaths a year in the 28 member nations in the European Union. Meanwhile, the Delhi High Court granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement in India. This was announced by DSM Sinochem Pharmaceuticals (DSP), a leading company in the production and commercialization of sustainable, enzymatic antibiotics, next generation statins and anti-fungals, This patent, which is owned by DSP, relates to amoxicillin trihydrate having a low free water content and processes for the manufacture thereof. The permanent injunction prevents the manufacture, use, importation, offering for sale and sale of Weiqida’s amoxicillin trihydrate API in India, as well as any drug product that utilizes the API. Pfizer sued by 70 arthritis patients; study reveals safety risks after drug approvals The world’s biggest pharma company Pfizer is being sued by 70 arthritis patients in Scotland, who say they were hit with terrible side effects from Celebrex, an anti-inflammatory painkiller touted as a wonder drug. The patients — both men and women in the age group of 60 to 90 years — are collectively seeking US$ 4.54 million (£3.5 million) in damages from the New York-headquartered pharma giant. They began taking Celebrex in 2002 to combat the effects of arthritis and muscle and joint stiffness. However, they went on to suffer health problems, including heart attacks and strokes. The Scottish patients hold good chances of winning the case. A recent study — titled Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010 — claims that almost a third of drugs cleared by the American regulator pose safety risks that are identified only after their approval. The study, that appeared in The Jama Network last week, says there is need for ongoing monitoring of new treatments years after they hit the market. Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 71 (or 32 percent) were affected by a post-market safety event. Post-market safety events were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval, the study said. After Roche and AstraZeneca, Amgen suffers a setback on its osteoporosis drug Earlier this month, both Roche and AstraZeneca had faced setbacks in the late-stage study of their drugs. Roche had reported its Tecentriq drug failed to significantly improve overall survival in a late-stage bladder cancer study. And an experimental biotech drug for severe asthma from AstraZeneca failed to meet its goal of significantly reducing attacks in a late-stage study. As if to continue the trend, last week Amgen’s top-stage drug prospect aimed at treatment of osteoporosis — romosozumab — faced some serious setbacks. What initially seemed like happy news — that the late-stage trial comparing romosozumab to Fosamax hit its primary and key secondary endpoints — turned into some serious questions about the future of romosozamub. The first big setback was a prominent cardio risk imbalance between romosozumab and Fosamax — 2.5 percent for romosozumab and 1.9 percent for Fosamax. The second big setback came from the FDA, which wants to evaluate the new set of head-to-head data before approving romosozumab. And that means no decision is expected this summer! Humira loses key patent battle as J&J tries to block Samsung’s Remicade biosimilar AbbVie’s Humira — the world’s best selling drug which is a treatment for rheumatoid arthritis — received a setback when the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) handed down a verdict in favor of Coherus BioSciences, a biopharma company in the US. The verdict struck down AbbVie’s ‘135 methods patent on Humira after an inter partes review. The patent had been labelled as a shield and “one of the cornerstones of the Humira IP estate,” by Barclays analysts. However, all IPR decisions are subject to appeal. In a statement, AbbVie said it does plan to appeal against the verdict. Meanwhile, a unit of Johnson & Johnson filed a lawsuit to block the sale of a copy of its rheumatoid arthritis drug Remicade made by South Korea's Samsung Bioepis in the US. Remicade is J&J’s biggest selling drug, with US sales of about US$ 5 billion a year. Through the law suit, the J&J company — Janssen Biotech Inc — has sought a preliminary or permanent injunction to block Samsung Bioepis' biosimilar of Remicade, from sale in the US. Frontida BioPharm gets FDA’s ‘all clear’ for Philadelphia plant bought from Sun In June last year, Frontida BioPharm had bought Sun Pharmaceuticals’ finished pharmaceutical plant in Philadelphia. And barely eight months back, it received an FDA warning letter for this plant, based on an inspection that took place in 2015. The warning letter had mentioned that Sun Pharma’s quality unit at the time had knowingly released 27 lots of various strengths of clonidine HCl tablets, despite evidence that the API used in manufacturing was potentially contaminated. The warning letter had been issued in August 2016, and Frontida knew about the regulatory issues when it acquired the facilities last year from Sun Pharma, India’s largest drugmaker. The good news is that Frontida BioPharm says the US FDA has given the plant an all-clear. Frontida says Sun helped it address these issues. With the regulatory issues behind it, Frontida can now move forward with its expansion plans. “The positive resolution of our regulatory status with the FDA will stimulate Frontida’s expansion and growth, and enable Frontida to better support our partners to bring new products to the market,” Frontida CEO Song Li said in a statement. FDA warns drug makers to check water systems for BCC contamination The US FDA has warned manufacturers of non-sterile, water-based drug products of Burkholderia cepacia complex (BCC or B cepacia) contamination, as there have been recent product recalls due to this and other water-borne opportunistic pathogens found in pharmaceutical water systems. The regulator’s warning stems from multi-state outbreak of infections. In March this year, Phispers had carried a news item on Badrivishal Chemicals & Pharmaceuticals, a manufacturer of docusate sodium. It had been placed on FDA’s import alert list in December last. The FDA warning letter issued to Badrivishal talks about adulteration with BCC. The facility used water as a drug component and for cleaning the facility and equipment. The water source was a river in the vicinity which passes through farmland, where it is subject to agricultural runoff and animal waste, before it reaches the Badrivishal manufacturing site. FDA’s concern was that contaminated water has been the root cause of multi-state outbreak of infections and multiple recalls by other drug manufacturers of non-sterile liquids, including instances of adulteration with BCC. “BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents,” the FDA said. Detecting BCC bacteria is a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains. Laurus Labs to enter the US generics market; how will this impact Mylan? Last week, Laurus Labs announced that its API facility at Unit 2 in Vizag (India) cleared the US FDA inspection without any Form 483 observations. The unit manufactures APIs and finished dosage formulations (FDFs). This successful inspection will help the company as it plans to foray into the highly regulated US generics market. Does this suggest trouble for US generic drug giant Mylan? We think so. Laurus was started by Dr Satyanarayana Chava in 2007, and is a key manufacturer and supplier of APIs. With almost US $ 300 million in revenues, it holds its own against better-known competitors like Mylan. In fact, Laurus and Mylan have a lot in common. Both the companies are headed by men who worked together at Matrix Laboratories. Mylan acquired a controlling stake in Matrix around the time Chava founded Laurus Labs. Until then, Chava was the chief operating officer of Matrix, which was being headed by Rajiv Malik, the current president of Mylan. Laurus has also carved a niche for itself by supplying antiretroviral or ARVs (used to fight infections caused by retroviruses like HIV), hepatitis C and oncology drugs. And despite being a relatively new player, its clients include giants like Pfizer, Teva and Merck. APIs generally make up for 20 to 35 percent of the total cost of a drug, but the ones that Laurus develops, like ARVs, constitute 70 to 75 percent of the cost of the drug. Both companies have a stronghold in the treatment of AIDS. Globally, Laurus has achieved a leadership in the manufacture of ARV APIs. And in the case of Mylan, nearly 50 percent of patients receiving treatment for HIV/AIDS in the developing world rely on its product, all of which are made in India. In fact, Mylan is India's third largest pharmaceutical exporter. So seems like Mylan should watch out for Laurus as it forward integrates into making finished formulations. Laurus recently filed 2 Abbreviated New Drug Applications in the United States and submitted a dossier to the WHO (World Health Organization).

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25 May 2017

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Record fine levied on Pfizer for hiking drug price; US Senate clears biggest drug approval reform

This week, the US Senate cleared the 21st Century Cures bill, touted as the most significant reform in medical treatments. Phispers also brings you news on a court order that reverses a ban on 344 fixed-dose combination drugs in India, a shouting match between head honchos of pharma companies at a healthcare summit, a court order on J&J’s hip implant, and a warning letter to Interquim. US Senate clears Cures Act — the biggest reform on medical treatments On Wednesday, the US Senate passed the landmark 21st Century Cures Act. The bill had passed the House on November 30 and had advanced through the Senate earlier this week. After the vote, President Barack Obama said he would sign the measure “as soon as it reaches my desk.”The 21st Century Cures Act is a labyrinthine bill that would bring about significant changes in the way medical treatments are tested and brought to market over the coming decades. The legislation calls for the use of ‘data summaries’ to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.It includes ambitious goals to advance biomedical science, and will inject US $ 4.8 billion into a long-stagnating National Institute of Health budget.Critics call this deregulation, and a wolf in sheep’s clothing. They worry that both science and patients are going to suffer. They have argued the legislation is too friendly to Big Pharma, won’t curb high drug prices and may lead to unsafe treatments being put on the market. Tucked away in the 99-page bill are provisions that are likely to weaken the authority of the FDA as the bill includes language to put forward “real-world evidence” to support the approval of a new indication (or use) for an existing drug.Indian court quashes ban on fixed dose combination drugs As the 21st Century Cures Act will take us to an era of ‘inject and see’, the Indian government may want to see if the debate on banning fixed-dose combination (FDC) drugs can be resolved using ‘real-world evidence’. A government order banning 344 FDC drugs was overturned last week when the court was hearing a plea filed by pharmaceutical companies challenging the March 10, 2016 order which banned 344 FDC drugs. The ban included several common cough syrups, analgesics (pain killers) and anti-diabetes combinations.Pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and is not aligned with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They argued that the decision was taken without considering clinical data. And that it was based on an ‘absurd’ claim that there are safer alternatives available in the market today.Pfizer fined US $ 106.5 million in UK for hiking price of epilepsy drug The Competition and Markets Authority in the UK fined Pfizer a record US $ 106.5 million (GBP 84.2 million) for its role in increasing the cost of an epilepsy drug by a whopping 2,600 percent. The CMA also fined Flynn Pharma US $ 6.58 million (GBP 5.2 million) for overcharging for phenytoin sodium capsules.The ruling comes at a time when there is a growing debate both in the US and Europe about the ethics of price hikes for old off-patent medicines that have little competition.Pfizer used to market the (epilepsy) medicine under the brand name Epanutin, but sold the rights to Flynn, a privately owned British company, in September 2012. It was then debranded — i.e. it was no longer subject to price regulation — and the price soared.“The companies deliberately exploited the opportunity offered by debranding to hike up the price for a drug which is relied upon by many thousands of patients,” Philip Marsden, chairman of the CMA’s case decision group, said.“This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behaviour,” Marsden addedPfizer, Regeneron CEOs get into a shouting match at healthcare summit At the Forbes Healthcare Summit held last week, a panel featuring Gilead CEO John Milligan, Pfizer CEO Ian Read, incoming Eli Lilly CEO David Ricks, Astellas Americas President Jim Robinson, and Regeneron CEO Leonard Schleifer were asked to contemplate on why the pharma industry isn't liked.While the panel discussed middlemen and adding value, Schleifer offered his own take.“I think you've just seen why our industry isn't liked. You've asked a question why we're not liked, we are a room full of people who are biased to like us, and nobody answered the question why we're not liked,” Schleifer said.“We dispelled of some of it last year, because we blamed it on the extremists, the people who come in, dial up a product that's off patent, raising price ten-fold and they're evil-doers, that's why we're not liked,” he continued. “But the real reason we're not liked, in my opinion, is because we as an industry have used price increases to cover up the gaps in innovation. That's just a fact.”Pfizer’s Read countered this with an often cited statistic that drug costs as a percentage of healthcare expenses haven’t changed in two decades, regardless of price increases.Schleifer’s response: “You’re not entitled to a fraction of the GDP.” What followed was a shouting match, until a member of the panel interjected. The pharma industry surely needs a unified message to send out to the world. Spain’s Interquim gets FDA warning letter for using dirty equipmentThe latest company to receive a warning letter from the FDA is Interquim SA of Spain. FDA investigators found the presence of residue in the interior surfaces of non-dedicated drug manufacturing equipment at Interquim that were labeled “clean.” Inadequate removal of residues from manufacturing equipment during cleaning can lead to cross-contamination of API subsequently manufactured, using the same equipment.Investigators also questioned the impact on API quality of the product produced from equipment whose interior surfaces were discolored even after an equipment maintenance contractor had previously noted the damage and repaired it.Interquim is a part of Ferrer, an international group of more than 50 companies with activities in the pharmaceutical, hospital, diagnostics, fine chemicals, feed and food sectors. Headquartered in Spain, its products are sold in more than 70 countries. It is a leading manufacturer of APIs like Celecoxib, Imiquimod, Paliperidone Palmitate, Rivaroxaban, Rivastigmine, etc. Explosion at excipient manufacturer in India claims two livesAn explosion at a manufacturer of pharmaceutical excipients — Nitika Pharmaceutical Specialities — in India claimed two lives and injured 19 others. While initial news reports claimed a boiler explosion, a report submitted by the inspector of boilers stated: “The explosion at M/s Nitika Pharmaceuticals Pvt Ltd is not a case of boiler explosion. There is no registered or exempted or unauthorized boiler in the unit. The heat requirement of the factory was being catered to by two thermic fluid heaters installed in the factory.”The local police arrested the company’s senior manager (operations), the senior manager (maintenance) and its managing director, who were later granted bail by the court. Cannabis cultivation to get boost due to upcoming approvalsGW Pharmaceuticals, a UK-based company focused on developing medicines from marijuana, plans to expand manufacturing in the UK and boost cultivation of the cannabis plants it uses to make a treatment for severe epilepsy.The British biotech firm is gearing up to submit Epidiolex — an experimental drug that has shown to be hugely effective in treating rare and life-threatening forms of childhood epilepsy —with US regulators in the first-half of 2017. Approval could come by early 2018.It was just last week that PharmaCompass covered the news of the medical cannabis sector managing to comply with pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical to market medical cannabis in Israel for pain management. Will Apple launch FDA regulated cardiac monitoring products soon?A collection of emails obtained by MobiHealthNews, through a Freedom of Information Act request to the FDA, indicates that since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space.In an interview with the Telegraph last year, Apple CEO Tim Cook had also hinted at a regulated medical device from Apple.“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else,” Cook had said. J&J to pay over US $1 billion in Pinnacle hip implants caseLast week, a federal jury in Dallas ordered Johnson & Johnson and its unit DePuy Orthopaedics to pay more than US $ 1 billion to six plaintiffs who said they were injured by the Pinnacle hip implants.According to the jurors, the metal-on-metal Pinnacle hip implants were defectively designed. And both companies failed to warn consumers about the risks. J&J and DePuy have been hit with nearly 8,400 lawsuits over the devices.However, verdicts of such size are often lowered by courts. In July, the judge presiding over this case reduced a US $ 500 million verdict in an earlier Pinnacle implant case to US $ 151 million by citing a Texas state law that limits punitive damages awards.

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08 Dec 2016

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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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14 Apr 2016

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The future of API manufacturing at Dr. Reddy’s

Almost immediately after our analysis on why “Dr. Reddy’s largest API facility maybe the next to get banned from exporting to the United States”, a stock analyst stated that there were “hopes of US FDA resolution of Srikakulam plant”. What does the future hold for API manufacturing at Dr. Reddy’s, currently the third largest API seller in the world? As part of the Reuters story, CLSA, a stock brokerage covering Dr. Reddy’s, based their assessment that Dr. Reddy’s troubles are behind them as “one of its customers has received approval for a product, referencing a drug master file from this facility”. While the CLSA report is very positive for Dr. Reddy’s, it’s strange that other than CLSA nobody else has covered this important event. In an attempt to verify CLSA’s statement, we compiled a list of all recent generic approvals (since March 15) which were cross referenced using the Dr. Reddy’s @ PharmaCompass database to determine the active ingredients produced at their Srikakulam facility. Date Product Application Holder March 26, 2015 Tolcapone Par Pharma March 23, 2015 Argatoban Injection Fresenius Kabi USA March 19, 2015 Zoledronic Acid Hospira Inc March 18, 2015 Tenofovir Disoproxil Fumarate Teva Pharmaceutical USA March 17, 2015 Lacosamide (Tentative Approval) Aurobindo Pharma March 16, 2015 Celecoxib Lupin March 16, 2015 Fluoxetine Hydrochloride Sciegen Pharmaceuticals While Dr. Reddy’s produces 4 out of these 7 recently approved products (Zoledronic Acid, Lacosamide, Celecoxib and Fluoxetine Hydrochloride), only Lacosamide is produced at the Srikakulam facility. The assessment is based on the Written Confirmations granted by the Indian Drug Regulator which serve as a good guide to know which products are being manufactured in which facility. The issuance of the Written Confirmation requires physical verification of production at the site by the local authorities, which is not necessarily true in the case of DMFs and CEPs. The possibility of Aurobindo Pharma’s generic approval of Lacosamide being dependent on Dr. Reddy’s active ingredient is low, as Aurobindo Pharma supports their own USDMF. However, Aurobindo doesn’t have a Written Confirmation for Lacosamide.In their 2014 annual report, Dr. Reddy’s, defined their revenues from the Pharmaceutical Services and Active Ingredients (PSAI) division, which declined 21.9%, as a “low point” of their overall business. However, Dr. Reddy’s also acknowledges that PSAI is a strength, as it provides vertical integration to their global generics business. While Dr. Reddy’s has announced plans to the Ministry of Environment, to triple the size of their manufacturing capacity across three different production facilities, the facility in question, Srikakulam, is not part of the announced expansion plan. There still seems to be significant risk to Dr. Reddy’s North American business on account of the USFDA inspection of their Srikakulam API facility. Read more about: Dr. Reddy’s expansion plans for API production

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03 Apr 2015

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Find PharmaFlow Article for Tox21_300599

Tox21_300599

Tox21_300599

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

89 API Suppliers

31 USDMF

32 CEP/COS

12 JDMF

26 EU WC

51 KDMF

27 NDC API

46 Listed Suppliers

DEVELOPMENTS

64 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

24 Suppliers

DOSSIERs // Finished Dosage Formulations

331 Dossiers

100 FDA Orange Book

110 Europe

34 Canada

18 Australia

19 South Africa

50 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - 100MG

CAPSULE;ORAL - 200MG

CAPSULE;ORAL - 400MG

CAPSULE;ORAL - 50MG

TABLET;ORAL - EQ 10MG BASE;200MG

TABLET;ORAL - EQ 2.5MG BASE;200MG

TABLET;ORAL - EQ 5MG BASE;200MG

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Suppliers

20 BASF

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1 DKSH

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EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders

30 Direct Compression

28 Disintegrants & Superdisintegrants

19 Granulation