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    Teva’s fresh troubles over drug safety, Bollygarchs drug ‘price-gouging’ in Britain, Sun Pharma downsizes U.S. operations

    Teva’s fresh troubles over drug safety, Bollygarchs drug ‘price-gouging’ in Britain, Sun Pharma downsizes U.S. operations

    This week’s Phispers takes you through pharmaceutical news from across the globe – from Joe Biden’s computer aided cancer moonshot to AbbVie’s second largest venture capital buyout in history and a lot more. After GMP troubles, migraine patch gives Teva a fresh headacheLast week, Phispers carried news on Teva’s facility in Hungary, which was placed on the US Food and Drug Administration’s import alert list. The FDA inspection had found the plant not conforming to the current good manufacturing practices (GMPs). This week, there is more bad news for Teva Pharmaceuticals. The company had bought NuPathe in early 2014 for about US $ 114 million. Through this acquisition, Teva had got its hands on the only migraine patch approved in the US – known as Zecuity. The patch first hit the market in September 2015. However, in less than a year of its launch, Teva's Zecuity is under the FDA radar for concerns over “serious” adverse events including burning and scarring. Moreover, a large number of users have also reported other problems, such as severe redness, pain, skin discoloration, blistering and cracked skin, the FDA said.  Britain’s Patel brothers do a Martin Shkreli on drugs needed by NHSWhile America’s Martin Shkreli faced additional criminal charges this week of conspiracy to commit securities fraud during his tenure as the CEO of Retrophine (2012 to 2014), Britain saw its own avatars of Shkreli. Millionaire brothers Vijay and Bhikhu Patel, also known as ‘Bollygarchs’ – have been accused of being part of a group of businesses that hike up prices of common drugs needed by the National Health Service (NHS), the publically-funded healthcare system for England. The Patel brothers have allegedly exploited a loophole in NHS’ pricing system. Today the four businesses, including two with past and present links to the Patel siblings, have allegedly hiked the price of common drugs by up to 12,500 per cent. The unreasonably high prices have cost the NHS an additional £ 262 million (US $ 381 million) a year. This sum has conveniently gone into the pockets of the Patel siblings and their associates. Cancer treatment least affordable in India and ChinaWhile we all know that Americans pay the highest prices in the world for cancer drugs, a new study highlights how cancer treatments are least affordable in lower income countries. The study – presented at the annual meeting of the American Society of Clinical Oncology in Chicago – looked at the prices of cancer drugs in seven countries, while not taking into account discounts or rebates. The lowest drug prices were found in India and South Africa. But then, when adjusted for the cost of living, cancer drugs appeared to be least affordable in India and China. The study only strengthens the case for politicians, healthcare providers, doctors, insurers and patients, who have been opposing the high prices commanded by modern cancer drugs. Drug companies justify the high prices, citing the high cost of drug research and the need to make profits to continue spending on research and drug development. Sun Pharma sells two US facilities to Frontida BioPharmaSun Pharmaceuticals – India’s largest drug maker – is selling off two oral solid dosage manufacturing plants in the US to Frontida BioPharm Inc. (a part of Frontage Pharma). The sell-off is part of Sun Pharma’s plans to consolidate its manufacturing facilities in the US. The plants are situated in Philadelphia and Illinois. Sun Pharma earns about half of its total revenues from the US. And this is the drug maker’s second divestment in the US in the last six months. In December, it had divested its manufacturing plant in Ohio to Nostrum Laboratories.  The company is also looking to sell facilities and business units from the Ranbaxy portfolio. In September 2015, it put a plant in Ireland on the block to optimize its overall manufacturing base and also sold the central nervous system business (of erstwhile Ranbaxy) to Strides Shasun for INR 1.65 billion (US $ 24.8 million). China’s Fosun leads the race for India’s Gland Pharma with US $ 1.27 billion bidLast week, Hong Kong-listed Shanghai Fosun (Fosun Pharma) revised its offer to buy KKR-backed Gland Pharma to US $ 1.27 billion, the highest so far. American healthcare company Baxter International and private equity fund Advent made their offers in May. The frontrunner for Gland Pharma, until recently, was Baxter with its bid at US $1.1 billion, a news report said. Fosun Pharma is part of Chinese billionaire Guo Guangchang’s extensive business empire. Fosun is believed to have completed its due diligence on Gland Pharma sometime last week. Final negotiations are planned for next week, and we hope to hear a formal announcement on Gland Pharma sometime in the third week of June. Joe Biden launches open-access cancer database as part of the Cancer Moonshot InitiativeOn Monday, American Vice President Joe Biden announced the launch of an open-access cancer database that will allow researchers to better understand cancer and develop more effective treatments. This first of its kind database, a part of the National Cancer Moonshot initiative, known as the Genomic Data Commons (GDC), contains the raw genomic and clinical data of 12,000 patients. The database has detailed analyses of the molecular makeup of cancers and information on which treatments were used and how patients responded. The database will encourage the much-needed collaboration among scientists in different disciplines to research important aspects of cancer and find new ways to help patients, Biden told doctors.  Medicines containing aspirin can cause stomach bleeding, warns FDAAspirin-containing medicines to treat heartburn, sour stomach, acid indigestion, or upset stomach can cause stomach or intestinal bleeding, warns the USFDA. Since aspirin thins the blood, FDA believes the aspirin in these combination medicines is contributing to major bleeding events. The instances of bleeding, however, are rare. In 2009, FDA had issued a warning about serious stomach bleeding risk with aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). When FDA reviewed its Adverse Event Reporting System database, it found eight new cases of serious bleeding caused by aspirin-containing antacid products since the 2009 warning. Some of those patients required blood transfusion. “Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” an FDA official said. AbbVie blockbuster buyout disappoints investorsOn Sunday, AbbVie began explaining why it paid a whopping US $ 5.8 billion upfront – with US $ 4 billion reserved for milestones – for biotechnology company Stemcentrx and its cancer drug Rova-T (rovalpituzumab tesirine). AbbVie’s acquisition of Stemcentrx is the second largest venture-capital backed startup acquisition in history, after Facebook paid $19 billion to buyout WhatsApp.  However, the first set of data provided by AbbVie disappointed investors. Although the drug’s performance against small cell lung cancer, a disease which has not seen a change in survival rates since the 1970s, showed that 68 percent of the patients achieved a clinical benefit, the expectations from the investor community were much higher.Rova-T targets a protein called “DLL3 that is normally found only deep inside cells. But DLL3 winds up all over the outside of some types of cancer cells. Rova T pairs an antibody, which detects DLL3, with a powerful chemotherapy that kills the cells the antibody detects.”  Major fire at Nectar Lifesciences plant in Punjab, IndiaOn June 3, a fire broke out in Unit-II of Nectar Lifesciences Limited, a leading pharmaceutical company, in India. Huge stocks of pharmaceutical products, chemicals and goods were destroyed in the fire. However, no loss of human life was reported. The fire broke out around 9.15 pm at the solvent recovery plant and spread to the other sections of the unit and caused damage. Fire tenders had to be arranged from neighboring cities to douse the flames.Nectar Lifesciences is a manufacturer of both active pharmaceutical ingredients and finished formulations with a focus on antibiotics like Cefixime, Cefpodoxime Proxetil, Ceftazidime etc.  

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    https://www.pharmacompass.com/radio-compass-blog/teva-s-fresh-troubles-over-drug-safety-bollygarchs-drug-price-gouging-in-britain-sun-pharma-downsizes-u-s-operations

    #Phispers by PHARMACOMPASS
    09 Jun 2016
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    Does speedy action by European agencies suggest revival of API production in the West?

    Does speedy action by European agencies suggest revival of API production in the West?

    Recently announced regulatory action against Indian and Chinese companies is creating a significant imbalance in the global supply chains of APIs. This imbalance is likely to open opportunities for other companies in Asia, and may also drive manufacturing back to Europe and the US.Last week, three companies – one in India and two in China – ran into problems with European regulatory agencies due to inspections conducted at their facilities. Data falsification, a problem recurring in Asia for the past few years, raised its ugly head yet again. The three companies that received non-compliance reports were plagued with problems similar to those seen in the past at the Asian operations of Ranbaxy, Wockhardt, Zhejiang Hisun, Novacyl etc. The European regulatory actionTake the case of Jinan Jinda Pharmaceutical Chemistry, China, where an inspection was conducted on June 26, 2015, by the Italian Ministry of Health. An unofficial and non-controlled storage area containing mainly raw materials and finished products was made inaccessible to the inspectors. Since the door of the area had been removed and replaced with a panel fixed with screws to the wall, the inspection team concluded that there was a serious risk of data falsification. At Parabolic Drugs, India, where an inspection was conducted by the Italian Ministry of Health on June 17, 2015, the inspectors found the quality management system to be seriously uncontrolled and deficient in almost all “principles” mentioned in the EU’s Good Manufacturing Practices (EU-GMP) guidelines. Falsification of data and documents along with integrity and security of data in the quality control laboratory were among the observations listed in the non-compliance report.Similarly, at Wuxi Jida Pharmaceuticals, China, inconsistent and conflicting answers were received from the personnel and the management.  The fact that answers were modified according to the inspectors’ requests and that documentation was shown in an ambiguous way led the Italian inspection team to conclude that the company did not comply with the requirements of EU-GMP.The Certificates of Suitability (CEP/COS), given to certify that the material complies with the requirements laid down in the relevant monograph of the European Pharmacopoeia, of these three companies were suspended.  A sense of urgency in EuropeThe time between the Italian inspections and issuance of the non-compliance report was less than six weeks. This turnaround is quite remarkable, considering this is peak holiday season in Europe.Last week also witnessed the US FDA, which has historically been more active compared to the Europeans, issue a warning letter to Mahendra Chemicals in India. During a May 2014 inspection, the US FDA inspectors found employees had completed batch production record entries days after operations had ended. Moreover, they released lots before proper approvals, and failed to maintain original manufacturing data for critical steps. Investigators found backdated batch production records, signed by the Technical Director, who stated he was not in the facility on the dates when the records were signed. Even though such glaring concerns related to data integrity were observed, it still took the US FDA over a year to issue the warning letter; substantially longer than the six weeks taken by the European regulatory agencies.However, the speed of the issuance by the Italian Ministry of Health is not drastically different to the Romanian Health Authority, which issued a non-compliance report (NCR) to Zhuhai United, China, in June 2015, for an inspection held in April. Similarly, the Slovenian Health Authority issued an NCR to Polydrug Laboratories, India, within three months (the inspection was held in March this year). In the case of Huzhou Sunflower, China, the French health agency issued an NCR in March, while the inspection was held in January this year.The recent EU ban on 700 generic medicines due to manipulation of clinical trials at Indian GVK Biosciences, is yet another case which highlights the recent action taken by the European regulatory agencies (read our previous analysis: Will data integrity concerns on clinical trials done at GVK Biosciences go beyond Europe?).  New market opportunities in an imbalanced supply chainThe outcome of these inspections create market opportunities for other competing firms. Jinan Jinda’s inspection was focused on an antibiotic used to treat urinary tract infections – known as Nitrofurantoin. Post the inspection, Jinan is prohibited from supplying Nitrofurantoin to the European market.As per the PharmaCompass database, Jinan Jinda is one of the three holders of a COS/CEP for Nitrofurantoin and the recommended suspension of their COS/CEP is an opportunity for the other two COS/CEP holders – global generic major Mylan Laboratories and Indian company, Unimark Remedies. In addition to these companies, FIS Fabbrica Italaina Sintetici and Cambrex Profarmaco, both based in Italy, are also active in the business of supplying this API. Unlike Jinan Jinda, which only had one CEP filing, India’s Parabolic Drugs produces multiple antibiotics, although not at the scale of global majors Sandoz, Fresenius Kabi and DSM. A suspension of 11 active CEPs, which had been granted to Parabolic, does seem to indicate an apparent shift in the supply chain of APIs. However, the suspension of Parabolic’s CEPs means that for antibiotics like Pivampicillin, there are no suppliers left who have a valid CEP. Parabolic’s inability to supply the market with products like Dicloxacillin Sodium, for which the inspection was conducted, is an opportunity for Sandoz, Aurobindo Pharma and the Italian operations of Fresenius Kabi – all of whom are integrated manufacturers and are not specialized API suppliers. For another antibiotic Bacampicillin, following the suspension of Parabolic Drugs, Fresenius Kabi’s Italian operations will be the only supplier left with a valid CEP.With Sandoz’s recent announcement of their plant shut down in India and the fate of Ranbaxy’s manufacturing operations being uncertain, under the new management of Sun Pharma, the supply options for CEP grade Cefopodoxime Proxetil get reduced substantially and are now dependent on just two plants -- Hanmi Fine Chemical in Korea and Sandoz’s Austrian operations. The situation thus created is not drastically different to the one resulting from the inspection failure of North China Pharmaceutical Group Semisyntech, which left Sandoz as the only manufacturer of Benzylpenicillin Procaine (this was before Novartis announced the shutdown of their Frankfurt facility).PharmaCompass has summarized a list of all CEPs for the 12 products (11 of Parabolic and 1 of Jinan Jinda), in case our readers want to assess the status of their overall supply chain in view of the recent inspection outcomes (please click here to send us a request). Our viewWhile the US FDA inspectors have historically been more active, the recent months have shown a sense of urgency on the European side as well. The era where companies were securing their supply of APIs by looking for low-cost players in Asia appears to be waning away.In our view, inspection outcomes like these may well drive manufacturing back to Europe and other countries where the cost of manufacturing has historically been high. The devaluation of the Euro, coupled with the speed with which regulatory action has been taken on these Indian and Chinese firms, seem to suggest that trade protection conversations may well get started in the not-so-distant future. 

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    https://www.pharmacompass.com/radio-compass-blog/does-speedy-action-by-european-agencies-suggest-revival-of-api-production-in-the-west

    #Phispers by PHARMACOMPASS
    06 Aug 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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    https://www.pharmacompass.com/radio-compass-blog/will-data-integrity-concerns-on-clinical-trials-done-at-gvk-biosciences-go-beyond-europe

    #Phispers by PHARMACOMPASS
    28 May 2015
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