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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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GSK’s overhaul begins under new CEO; Sandoz loses US$ 940 million lawsuit

This week, Phispers brings you news on GSK, whose new CEO is planning a slew of initiatives to make the British drug giant more competitive. This means more challenges for Luke Miels, AstraZeneca CEO Pascal Soriot’s former deputy who is joining GSK as head of pharma division. Soriot, on the other hand, put all rumors to rest in a memo to his staff. In other news, Donald Trump unveiled a glass vial project that will create more jobs in America. And Teva announced job cuts in Israel. While Momenta-Sandoz lost a case to Amphastar. GSK overhaul begins under new CEO; AZ’s Soriot puts (Teva) rumors to rest in a memo Pascal Soriot, chief executive of AstraZeneca, put all rumors to rest and told his staff that he expects to work together with them and see the company succeed. A report in the Israeli media earlier this month had said Soriot was in talks to join Teva. Last week, PharmaCompass reported that Soriot had dropped the offer. Though he did not mention Teva, in a memo, Soriot said: “Together, we are poised to achieve something remarkable and that few thought possible…Nothing can break the momentum you have established, and certainly not rumors.” Soriot is reportedly attending the European Society for Medical Oncology (ESMO) annual meeting in Madrid in September, in case AstraZeneca has its clinical data on its new immunotherapy medicine ready to present at the event. Meanwhile, Soriot’s deputy, Luke Miels, is joining GlaxoSmithKline as head of its pharma division. And if news reports are to be believed, employees are going to need courage to work under the Emma Walmsley, the new CEO of the British drug giant. Walmsley is looking for ways to make GSK more competitive. And in order to achieve that, she is pushing some functions and a lot of accountability into GSK’s three divisions. Their leaders will own the successes, as well as any failures. According to news reports, GSK is selling its Horlicks brand in the UK, shutting the Slough plant where the malt drink is made and is abandoning a proposed US$ 457 million (£350 million) biopharmaceutical manufacturing plant in Cumbria. Walmsley also wants to improve drug research productivity, and wants GSK to have fewer but potentially more lucrative new drug launches in the future. GSK is planning on scrapping more than 30 drug development programs and will focus 80 percent of its R&D budget on the top candidates in four therapeutic areas and potentially exit the rare disease space. Momenta-Sandoz lose case to Amphastar; AbbVie to pay US$ 150m in damages In the US, Amphastar Pharmaceuticals won a case in a federal court against Momenta Pharmaceuticals Inc and its partner Novartis AG’s Sandoz unit. The two had sought nearly US$ 940 million in damages against Amphastar. Momenta and Sandoz had filed the lawsuit in 2011 after the US Food and Drug Administration (USFDA) had approved Amphastar’s generic version of Sanofi’s blockbuster Lovenox, an anticoagulant used to treat and prevent blood clots. The two companies had accused Amphastar of infringing on a patent held by them, through the production of a generic version of the blood-thinner Lovenox. In a statement, Momenta CEO Craig Wheeler said the company was disappointed and was considering its options, including a potential appeal. “We continue to believe in the importance of investing in innovative techniques for bringing products to market and protecting those innovations from unauthorized use,” he said. Momenta and Sandoz suffered a major setback earlier this year when Pfizer’s fill/finish manufacturing facility in McPherson, Kansas, received a warning letter from the USFDA. The compliance concern had been initially revealed by Momenta in a press statement as the company, in collaboration with Sandoz, is developing a generic version of Teva’s long-acting Copaxone® 40mg/mL (glatiramer acetate injection). Sandoz had tied up with Pfizer as its fill/finish manufacturing partner. Copaxone generated US$ 4.22 billion in sales last year. Meanwhile, a federal jury in Chicago found AbbVie Inc fraudulently misrepresented the risks of its testosterone replacement drug — AndroGel. The jury ordered AbbVie to pay US$ 150 million in punitive damages. A lawsuit had been filed in 2014 against AbbVie by Jesse Mitchell and his wife. The decision in the Mitchell case is the first in a series of test trials aimed at helping plaintiffs and manufacturers of AndroGel assess the range of damages and define a legal strategy and settlement options for such trials. The jury said AbbVie was not “negligent or strictly liable” for a heart attack Mitchell suffered after taking AndroGel. However, it said AbbVie falsely marketed the drug. And, it did not award Mitchell compensatory damages for his injuries and losses. Trump unveils glass vial project that is likely to create 4,000 jobs in the US Last week, the US President Donald Trump announced an initiative to manufacture a new kind of glass for injectable drug vials. Corning Inc is making a US$ 500 million investment along with pharma giants Merck and Pfizer to manufacture these vials, which are likely to create nearly 1,000 jobs at facilities in New York and New Jersey and another ‘yet to be announced’ site in southeastern USA. This initiative was part of Trump's ‘Made in America’ week, during which he showcased America-made products. Trump also defended his administration’s ‘America First’ policies. He was joined by the CEOs of Corning, Merck and Pfizer. Trump said the deal could eventually result in a total investment of US$ 4 billion and create around 4,000 jobs. “This initiative will bring a key industry to our shores that for too long has been dominated by foreign countries. We’re moving more and more companies back into the United States,” Trump said. According to Trump, the glass is called Valor Glass and is a “substantial improvement” in quality over existing products. It has superior strength and is more damage-resistant. In Israel, Teva pulls out the job axe; Japan’s Mitsubishi Tanabe buys Neuroderm Teva Pharmaceutical Industries recently announced that it is beginning negotiation with the labor groups in Israel. It is expected to cut 300 to 350 workers and managers at production sites in Histadrut and Ramat Hovav in the coming months. This move will be yet another step towards Teva’s restructuring and business focus, aimed at bolstering the competitiveness of its sites in Israel. Post this announcement, Histadrut called a work dispute, which will permit employees to strike in 14 days time. Teva currently has 7,000 employees in Israel. Histradrut spokesman Yaniv Levy said: “We will not accept any unilateral measure in which workers are laid off at Teva. We expect the company’s management to act responsibly, and not to involve Teva’s plants in Israel in a series of conflicts that will escalate labor relations.” Meanwhile, Japan's Mitsubishi Tanabe Pharma has agreed to buy Israeli drug maker Neuroderm for US$ 1.1 billion in cash as part of a strategy to grow its business in the US. Mitsubishi Tanabe said it is particularly attracted by Neuroderm’s Parkinson’s disease drug that is in advanced clinical trials in the US and Europe and is likely to be launched in 2019. A minor molecule twist could be the solution to cancer that killed Steve Jobs Last week, a nuclear medicine targeted at the type of cancer that killed former Apple Inc co-founder and CEO Steve Jobs got a nod from the European Medicines Agency (EMA), boosting prospects for its developer — Advanced Accelerator Applications (AAA). The EU drugs regulator said its Committee for Medicinal Products for Human Use (CHMP) had recommended the product — Lutathera (lutetium 177 dotatate). This emerging treatment targets gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The drug is likely to get a full approval in the coming two months. Stefano Buono, chief executive officer of AAA, said the company was also ready to re-file its application for US marketing approval with the USFDA this month. This French biotech company has described the new drug as a “multi-hundred million” dollar opportunity. Lutathera has the potential to transform AAA’s fortunes. Buono’s AAA, which was spun off from Europe’s physics research centre CERN 15 years ago, had sales from existing diagnostic products of US$ 34.9 million in the first quarter of 2017. Lutathera is unusual in harnessing the same molecule that is already used to diagnose cancer to also deliver treatment. After Celgene, Cardinal Health pulls out of China due to regulatory concerns After Celgene decided to reduce its footprint in China earlier this month, in order to support only its clinical development and regulatory affairs activities in the country, this week we heard about US drug distributor Cardinal Health putting its China business on the block. As per news reports, state-backed Chinese pharma companies have evinced interest in a deal that may be worth up to US$ 1.5 billion. Shanghai Pharmaceutical, China Resources Pharmaceutical, and Sinopharm are among those evincing interest in buying Cardinal Health, one of China’s largest drug distributors. Ohio-based Cardinal wants to exit the country due to concerns around China's upcoming drug distribution reform, which is likely to slow down its growth. Cardinal has also been diversifying — in April it announced a US$ 6.1 billion deal for Medtronic Plc’s medical supplies units. It has reportedly hired Lazard as an adviser for the China sale and the first round of bidding is due later this week.Meanwhile, Celgene is offloading its Chinese operations to the biopharmaceutical major Beigene. It is also giving Beigene the rights to Abraxane, Revlimid and Vidaza in China. This way, Beigene will assume responsibility for making and selling the approved drugs, along with Celgene’s pipeline prospect CC-122 in China. Celgene had also announced that it would buy a stake in BeiGene to help develop and commercialize the China-based cancer immunotherapy developer's treatment for solid tumor cancers, expanding its position in the field of immuno-oncology. When the deal closes in the third quarter of this year, Beigene will instantly become a commercial-stage biotech.

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27 Jul 2017

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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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04 Aug 2016

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Marijuana Based Medicines – highway to pots of gold

Legally cultivated cannabis, in some parts of the United States, resulted in a boom, which could never have been previously imagined. Just last year, there were so many growers that, in the state of Washington alone, more than 20,000 kg of marijuana (cannabis) was available, which didn’t have any takers!Last year also saw the stock market recognize the value of little known, GW Pharmaceuticals, a UK based company, focused on developing medicines from marijuana. Their product, Sativex, already approved in 27 countries is currently awaiting USFDA approval. With Wall Street valuing GW Pharmaceuticals at almost $2 billion, is there a future for marijuana based medicines? Increasing production of legal marijuanaMarijuana or cannabis, is ‘still’ classified as schedule 1 drug, which means that the Drug Enforcement Agency (DEA), believes there is no currently accepted medical use and the drug isn’t safe to use even under medical supervision. However, with all the research interest, the DEA has proposed a massive increase in the amount of marijuana production. It will hopefully allow, that the demands of the researchers will finally be met. Highly curative?There are two key active ingredients inside Marijuana, Cannabidiol (CBD) and Tetrahydrocannabinol (THC). While the potency of marijuana is linked to the amount of Tetrahydrocannabinol (THC) inside it, Cannabidiol (CBD) which isn’t responsible for the high, is the one considered to have the wider scope for medical applications. Epidiolex// treatment of epilepsy in children?An orally-administered liquid containing CBD has received orphan drug status in the US, under the brand name Epidiolex. GW Pharmaceuticals, the developer of Epidiolex is also performing their second Phase III clinical trial to demonstrate its effectiveness in the treatment of epilepsy in children. Sativex// treatment of spasticitySativex, a mixture of THC and CBD, is approved for sales in countries for the treatment of spasticity (muscle spasms and stiffness) related to multiple sclerosis; a disease that affects 1.3 million people worldwide, of which up to 80% suffer from spasticity.In addition to THC and CBD, GW Pharmaceuticals, has also developed a portfolio of products based on the other cannabinoids found in the plant. Marinol// approved in 1985GW Pharmaceuticals isn’t alone since synthetic derivatives of THC have also been on the market for years. Dronabinol (brand name: Marinol), approved in 1985 for prevention of nausea and vomiting during chemotherapy, is estimated to have current sales of almost $450 million. After the initial launch, the product also got approval for appetite and weight loss in patients with HIV/AIDS. The product got reclassified, in 1998 by the DEA, from a Schedule II drug to a Schedule III one which allowed access to a wider patient base. An open ‘high-way’ for businessInsys Therapetuics, another player in this space, who had their novel, more bio-available formulation of Dronabinol rejected by the FDA, still commands a market valuation of almost $3 billion. Plant based medicines, like Paclitaxel, Docetaxel, Morphine, Codeine have made billions for the pharmaceutical industry in the past and the market valuations of GW Pharmaceuticals and Insys Therapeutics indicates similar expectations for developing medicines from marijuana. With many other cannabinoids in the plant, raw material availability no longer as restricted as in the past, licensing opportunities on new indications available from the National Institute of Health (NIH)– it is just a matter of who hits the marijuana ‘high-way’ first?

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16 Jul 2015

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Dr. Reddy’s expansion plans for API production

Unrelated to the inspection of the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment, Forests & Climate Change to expand their drug and intermediate manufacturing at three locations. All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were Existing Capacity Planned Capacity Anticipated Investment CTO I 14.7 TPM 45.5 TPM Rs 30 crores CTO II 21.9 TPM 68.9 TPM Rs 45 crores CTO - III 4.45 TPM 28.1 TPM Rs 12 crores *$1 million is approximately about Rs 6.2 crores & TPM is tons per month In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below). Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business. Table Dr. Reddys production plans at various facilities Product Name Planned Capacity (TPM) Facility Location Alendronate Sodium Trihydrate 6.67 CTO - III Alfuzosin 2.33 CTO - I Altretamine 0.03 CTO - I Amlodipine Besylate 33.33 CTO - II Amlodipine Besylate 133.33 CTO - III Amlodipine Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2) 100 CTO - II Amlodipine Maleate 30 CTO - III Amsacrine 0.07 CTO - I Anastrazole 0.83 CTO - II Aprepitant 3.33 CTO - III Aripiprazole 0.33 CTO - II Atomoxetine 1.67 CTO - III Atorvastatin 375.83 CTO - II Azacitidine 0.67 CTO - I Bicalutamide 0.03 CTO - II Bivalirudin 0.03 CTO - II Bivalirudin Trifluoro Acetate 0.03 CTO - I Bortezomib 0.03 CTO - I Cabazitaxel 0.02 CTO - I Candesartan cilexetil 6.67 CTO - II Cetirizine Hydrochloride 66.67 CTO - I Cetirizine 16.67 CTO - II Ciprofloxacin 176.67 CTO - II Ciprofloxacin HCl 533.33 CTO - II Ciprofloxacin Lactate 33.33 CTO - II Clopidogrel Bisulfate 500 CTO - I Clopidogrel Premix 166.67 CTO - II Diluted Everolimus 5% (Everolimus) 0.33 CTO - II Disodium Pamidronate 0.33 CTO - III Docetaxel 1.9 CTO - I Dutasteride 3.33 CTO - II Esomeprazole magnesium 66.67 CTO - III Ezetimibe 3.33 CTO - II Fexofenadine Hydrochloride 500 CTO - I Finasteride 10 CTO - II Fluoxetine 110 CTO - I Fondaparinux Sodium 0.33 CTO - II Galantamine 0.03 CTO - II Gemcitabine 13.33 CTO - I Glimepiride 13.33 CTO - II Imatinib 0.17 CTO - I Irinotecan 0.33 CTO - I Ketorolac 66.67 CTO - II Lacidipine 5 CTO - III Lamotrigine 33.33 CTO - I Lansoprozole 8.33 CTO - III Letrozole 0.03 CTO - II Levocetrizine Di HCl 10 CTO - III Levofloxacin 200 CTO - II Lomustine 1.33 CTO - I Losartan Postassium 150 CTO - I Meloxicam 0.03 CTO - I Memantine HCl 3.33 CTO - II Mesalamine 0.03 CTO - II Metoprolol Succinate 266.67 CTO - II Moxifloxacin 116.67 CTO - II Norfloxacin 0.03 CTO - I Omeprazole 133.33 CTO - III Omeprazole Magnesium 50 CTO - III Omeprazole Sodium 10 CTO - III Omerprazole Form B 33.33 CTO - III Paclitaxel 0.33 CTO - I Pantoprazole Sodium 100 CTO - III paroxetine HCl 0.03 CTO - II Pemetrexed 0.67 CTO - I Rabeprazole Sodium 83.33 CTO - III Raloxifene 33.33 CTO - II Ramipril 100 CTO - III Repaglinide 6.67 CTO - II Rivastigmine 6.67 CTO - II Risperidone 13.33 CTO - I Rivastigmine 6.667 CTO - I Rizatriptan Benzoate 1.33 CTO - II Rocuronium Bromide 0.03 CTO - II Ropinrole HCl 1.83 CTO - III Rosiglitazone 3.33 CTO - II Sparfloxacin 3.33 CTO - I Tacrolimus 5 CTO - II Tadalafil 3.33 CTO - II Telmisartan 100 CTO - II Temozolamide 0.03 CTO - I Terbinafine HCl 133.33 CTO - III Tizanidine HCl 16.67 CTO - III Topotecan 0.07 CTO - I valganciclovir 0.03 CTO - I Vardenafil 3.33 CTO - II Voriconazole 8.33 CTO - III Ziprasidone Hydrochloride 100 CTO - I Zoledronic acid 0.33 CTO - III Zolmitriptan 0.83 CTO - I Zonisamide 0.03 CTO - II

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03 Apr 2015

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Cabazitaxel –The Market Overcrowding Begins

Many companies have been actively developing Cabazitaxel (Jevtana Kit®), a prostate cancer drug that belongs to the same class of molecules as off-patent blockbusters Paclitaxel (Taxol®) and Docetaxel (Taxotere®). Sanofi, the originator, has been struggling with sales of this molecule, as it has never lived up to its blockbuster expectations, with lackluster global sales of 273 million euros in 2014. The major part of the sales, 142 million euros, have been in Europe, where sales showed an increase of 28.2% over the previous year. Sales last year in the United States, on the other hand, grew only 5.8% and were 91 million euros. Lately, Sanofi received notice when Breckenridge Pharmaceutical, Inc., announced Paragraph IV ANDA litigation (1st generic filing) for Cabazitaxel. The first generic challenge followed the National Health Services’ (NHS) decision in the UK to remove the drug from the Cancer Drugs Fund approved list of medicines, because of its poor cost-effectiveness. Cabazitaxel, most often used after Docetaxel treatment (against cancers) has failed, has been priced at about $5,500 per treatment cycle, which is almost twice the cost of Docetaxel. With almost 9 companies having filed USDMFs for the different polymorphs of Cabazitaxel and significant development activity on this product in India, as shown by the import-export trade data, it remains to be seen if the investment will provide the anticipated returns, since Sanofi definitely does not seem to be having the same experience.

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11 Mar 2015

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Find PharmaFlow Article for NCGC00024995-07

NCGC00024995-07

NCGC00024995-07

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

106 API Suppliers

75 USDMF

29 CEP/COS

10 JDMF

8 EU WC

23 KDMF

21 NDC API

38 Listed Suppliers

DEVELOPMENTS

315 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

17 Suppliers

DOSSIERs // Finished Dosage Formulations

302 Dossiers

20 FDA Orange Book

88 Europe

5 Canada

8 Australia

126 South Africa

55 Listed Dossiers

DRUG PRODUCT COMPOSITION

INJECTABLE;INJECTION - 6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

POWDER;INTRAVENOUS - 100MG/VIAL

RELATED EXCIPIENT COMPANIES

Suppliers

2 BASF

1 Nanjing Bold Chemical

1 Nanjing Well Pharmaceutical

1 Corel Pharma Chem

EXCIPIENTS BY APPLICATIONS

3 Solubilizers

2 Parenteral

2 API Stability Enhancers

1 Topical

1 Emulsifying Agents

1 Granulation

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions

71 Finished Drug Prices

MARKET PLACE

30 APIs

26 DOSSIERS // FDF

PATENTS

21 US Patents

8 Health Canada Patents

ANALYTICAL SOLUTION(s)

5 EDQM Standards

4 USP Standards

16 Other Ref. Standards

DIGITAL CONTENT

6 Data Compilations & Company Tracker #PharmaFlow

257 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES

DOSSIERS // FDF

GLOBAL SALES (USD Million)

EXCIPIENTS

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

REF STANDARD

SERVICES

Top drugs and pharmaceutical companies of 2019 by revenues

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Dr. Reddy’s expansion plans for API production

Cabazitaxel –The Market Overcrowding Begins

INJECTABLE;INJECTION - 6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons