Raloxifene Hydrochloride
Phispers: IMS Health merges with Quintiles, FDA Compliance Director’s pay package, J&J’s Talcum Powder’s cancer risk
Phispers, our news capsule, brings you the latest recap from the world of pharma, such as up to 20 percent drugs sold in India could be counterfeit, Reckitt Benckiser’s killer disinfectants, after $200 million fine Gilead accuses Merck lawyer of lying, China’s multi-billion pharma opportunity and more.   FDA Compliance Director’s pay package pales in comparison with Clinton’s DCAT speaking fee PharmaCompass noticed a job opening at the US Food and Drug Administrations (FDA) – Director, Office of Compliance. The annual salary for this post mentioned was US $ 123,175 to US $ 185,100. Now compare this to what Hillary Clinton was paid to speak at DCAT’s Annual Dinner in 2014 – US $ 250,000. Or with Valeant’s new CEO Joseph Papa’s US $ 67 million package which could be worth US $ 500 million if Valeant shares reach their previous record high levels. The price that the department pays for a post that ‘touches the lives of every American’ certainly seems measly!   IMS Health in US $ 9 billion merger deal with Quintiles In an announcement which caught the market by surprise, industry leaders, contract medical research provider Quintiles Transnational announced a merger with healthcare information company IMS Health Holdings in a deal worth about US $ 9 billion. The combined company, which will have a market value of nearly US $ 18 billion, will offer services to drug and medical device makers, ranging from helping run clinical trials to tracking sales once a product has hit the market. The combined company – Quintiles IMS Holdings – will be led by IMS Health chief executive Ari Bousbib.    China’s blood plasma shortage throws opportunities for pharma companies While China’s blue-chip firms maybe sinking at the bourses, Shanghai RAAS Blood Products, a seller of treatments made from human blood plasma, is rallying new highs. It’s now China’s largest healthcare company by valuation with a market cap of almost US $16 billion (compare that with an IMS & Quintiles combination which is worth $ 18 billion). The big driver of growth is China’s surging demand for plasma-based therapies. Even though millions in China need these treatments, there’s scarcity of the blood plasma used to make them, partly because Beijing strictly controls the number of companies that have licenses to collect blood. GSK should definitely look into this opportunity as its sales in China have been tumbling. At the same time Biogen considers hemophilia to be a serious opportunity and plans to spin the division into a separate entity   Up to 20 percent drugs sold in India could be counterfeit In a special report, the office of the US Trade Representative (USTR) has raised major concerns about counterfeit drugs and devices. According to the report, 97 percent of all counterfeit pharmaceuticals seized at the US border in 2015 were shipped from four economies – China, Hong Kong, India and Singapore. Particularly, the USTR has raised concern about the proliferation of counterfeit pharmaceuticals manufactured, sold, and distributed in trading partners such as Brazil, China, Guatemala, India, Indonesia, Lebanon, Peru and Russia.  While it is impossible to determine an exact figure, studies have suggested that up to 20 percent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety.   Court orders J&J to pay US $ 55 million to woman who alleged talc caused cancer In February, J&J was ordered to pay US $ 72 million, in a St. Louis courthouse, to the family of a woman who died of ovarian cancer after having used J&J’s baby powder and another talc-based product for years. In another loss, Johnson & Johnson needs to pay US $55 million to a 62-year-old South Dakota woman who put the blame for her ovarian cancer on the company’s talcum powder. In the US, J&J is accused in more than 1,000 lawsuits in state and federal courts of ignoring studies linking its Shower-to-Shower product and Johnson’s Baby Powder to ovarian cancer. Women contend the company knew the risk and failed to warn customers. J&J, on the other hand, has denied any link between talc and ovarian cancer or any need to warn women.   After US $200 million fine, Gilead accuses Merck lawyer of lying In March, a federal jury in San Jose ordered Gilead to pay Merck US $200 million after finding that two US patents held by Merck and its partner, Ionis Pharmaceuticals, were valid and infringed by Gilead’s multibillion-dollar hepatitis C drugs – Sovaldi and Harvoni. The patents cover a range of compounds treating hepatitis C. Merck recently began selling its own hepatitis C drug – Zepatier. After the jury verdict, Gilead argued it shouldn’t have had to pay Merck because Merck was dishonest in obtaining its patents. Gilead said in 2004, Merck patent attorney Philippe Durette had a conference call with employees of Pharmasset, in which he learned the chemical structure of an experimental hepatitis C drug being developed by Pharmasset, code-named PSI-6130.  Gilead later spent more than US$11 billion to acquire Pharmasset and its hepatitis C drugs. Gilead said Durette misused what he learned on the call to subsequently change claims in pending Merck patent applications in a way that would cover Pharmasset’s technology.    Reckitt Benckiser apologizes for killer disinfectants, even as it misled patients in Australia Ataur Safdar, head of the Reckitt Benckiser’s Korean division, apologized for selling deadly disinfectants that killed or injured hundreds of people, five years after the government ordered the company to remove the products from shelves for health risks. Safdar said the company wanted to make amends, even as he was interrupted by angry and tearful victims and their family members. Meanwhile, an Australian court has ordered Reckitt Benckiser to pay 1.7 million Australian dollars in penalties after a ruling that the company misled consumers about the effectiveness of a popular painkiller.   Eli Lilly warns of job losses due to ban on carcinogen used to produce raloxifene Eli Lilly, one of Ireland’s largest pharmaceutical employers, has warned of job losses at its Kinsale plant if the EU does not exempt it from a forthcoming ban on ethylene dichloride (EDC) – a carcinogenic chemical. Eli Lilly uses the chemical to produce raloxifene, marketed as Evista, a prescription drug to prevent osteoporosis in post-menopausal women. The drug is currently used by 1.7 million patients worldwide. EDC will be banned within the EU from November 2017.   Goggles, hair, insects, dirt in APIs, reveals FDA warning letter to Polydrug Labs Polydrug Laboratories has been on FDA’s Import Alert List since September 2015. The warning letter issued by the FDA was posted on the regulator’s website and it talks about all kinds of uninvestigated complaints found on a torn sheet of paper recovered during the inspection.  Amongst these were complaints like low assay value in API and particles and hair, insect and dirt and safety googles found in API. According to the FDA, Polydrug failed to comply with current good manufacturing practices for the manufacture of APIs and also failed to record and investigate all quality-related customer complaints according to an established procedure. More details are available at Barbara Unger’s blog entry.   Effort to regulate drug pricing reaches G7 Summit In March, the French President Francois Hollande had said he would push for international regulation of drug prices when he meets leaders from other G7 countries in Ise-Shima (Japan) on May 26-27. News reports point that the issue is now on the agenda for the G7 Summit and health ministers will continue work on it in Kobe in September when other parties, such as the pharmaceutical companies themselves, could potentially be involved. France plans to press its G7 partners to launch an ‘irreversible’ process to control the prices of new medicines as part of a global drive to make life-saving drugs more affordable.  This news has come at a time when the UK too (like the US) is witnessing debates on price gouging, after the price of eye-drops used for bacterial conjunctivitis underwent a 14-fold price increase recently.   FDA’s generic drug approval report card  For the past few weeks, we have been mentioning an acceleration in the review process of generic drug applications filed with the FDA. The FDA recently released its Generic Drug Review Dashboard for the first quarter of 2016. It wasn’t surprising that the review process has been accelerated as the number of applications pending with the FDA have reduced by almost 10 percent with the burden of work now shifting to the industry which has to respond to the FDA’s comments or concerns.   

Impressions: 3071


05 May 2016
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

Impressions: 3050


03 Apr 2015