Haystack 2010 Year-In-Review
Dec17

Haystack 2010 Year-In-Review

This Friday, we're looking back at 2010's big news in pharma and biotech, both the good and the bad. Check out our picks and be sure to weigh in on what you think we missed. 1. Provenge Approved In April, Dendreon's Provenge became the first approved cancer immunotherapy. Dendreon CEO Mitch Gold called it “the dawn of an entirely new era in medicine.” And while prostate cancer patients are excited for a new treatment option, the approval is perhaps most exciting for its potential to reignite interest in cancer immunotherapy research. There’s a lot of room for improving the approach—Provenge is, after all, expensive and highly individualized. Now that immunotherapy have been proven to work, there’s hope that the lessons learned in both its discovery and clinical development will aid scientists in inventing even better cancer vaccines. 2. Obesity Field Slims The obesity drug race played out in dramatic fashion in 2010, with three biotech companies-Vivus, Arena, and Orexigen, each making their case for its weight-loss medication before FDA. As of this writing, Orexigen's drug Contrave seems to be on the surest footing to approval, but longtime obesity-drug watchers know that caution seems to rule the day at FDA, so nothing is a sure bet. Orexigen's Contrave and Vivus's Qnexa are both combinations of already-approved drugs, whereas Arena's Lorqess is a completely new molecule. When C&EN covered the obesity race in 2009, it seemed that Lorqess (then going by the non-brand-name lorcaserin) had the cleanest safety profile, but Qnexa was best at helping patients lose weight. But FDA's panels didn't always play out the way folks expected. There were safety surprises- notably the worries about tumors that cropped up in rats on high doses of Lorqess, and the extensive questioning about birth defect risks from one of the ingredients in Vivus' Qnexa. The fact that FDA's panel voted favorably for Orexigen's Contrave, a drug that's thought to have some cardiovascular risks, generated discussion because FDA pulled Abbott's Meridia, a diet drug with cardiovascular risks, from the market in October. The dust still hasn't fully settled. Arena and Vivus received Complete Response Letters from FDA for Lorqess and Qnexa. Vivus has submitted additional documentation and a followup FDA meeting on Qnexa is happening in January. Also to come in January is the agency's formal decision on Contrave. And if you're interested in learning about the next wave of obesity drugs coming up in clinical trials, read this story in Nature News. 3. Sanofi & Genzyme: The Neverending Story Speaking of drama, Sanofi’s pursuit of Genzyme has been in the headlines for months now, and promises to stretch well into 2011. The...

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Abbott Takes Diet Drug Meridia (Sibutramine) Off The Market
Oct08

Abbott Takes Diet Drug Meridia (Sibutramine) Off The Market

A diet pill bit the dust today- the Food and Drug Administration has asked Abbott Laboratories to take its drug Meridia off the market in the U.S. Meridia, or sibutramine, was approved by FDA in 1997, but the company voluntarily pulled Meridia after FDA's request, and is also halting sales of the drug in Canada and Australia. FDA's request was based mostly on a large study from last fall called the SCOUT trial. The trial suggested that patients on Meridia had more cardiovascular events, such as heart attacks and strokes, compared to patients taking a placebo. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), in an FDA press release. “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs,” Jenkins said. Meridia was already pulled from the market in the UK and other European nations earlier this year. You can click here to read more about how the drug works. And last month an FDA advisory panel was split as to whether to keep Meridia on the market here in the U.S. Of 16 panelists, 8 voted to withdraw the drug, 2 voted to keep it on the market with more strict warning label language, and 6 voted to keep it on the market with label revisions and restrictions on which doctors can prescribe the drug. The loss of Meridia isn't a big blow to Abbott's stock. Prescriptions for Meridia have already dropped over the years because of safety concerns, from a high of 1.3 million prescriptions in 1998 to 250,000 in 2009, according to FDA. But the next wave of obesity drug news, should it be similarly negative, could take a bigger toll on the companies involved, which are both smaller than Abbott. Mark your calendars for October 22 and October 28- these are the goal dates for FDA to finish reviewing applications for Arena Pharmaceuticals' drug candidate Lorqess and Vivus' Qnexa. FDA panels have recommended against approving both drugs. UPDATED 3:59 PM- to reflect withdrawal of Meridia from Canada and Australia as well as...

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Abbott Snags Top Spot in India With Piramal
May21

Abbott Snags Top Spot in India With Piramal

After much speculation about suitors ranging from Pfizer, GlaxoSmithKline, and Sanofi-Aventis, Abbott is coughing up $3.3 billion--$2.12 billion in cash up front and $400 million annually over the next four years--for the formulations business of Piramal Healthcare of India. The move makes Abbott top dog in the Indian pharmaceutical market, with a market share of roughly 7%. It’s a coveted position in an environment where the majority of drug industry growth is expected to come from emerging markets. Abbott has been ramping up its established products business since creating the separate division in 2007. Last fall, the company bought Solvay’s pharmaceuticals business for $7.6 billion, which brought a portfolio of branded generics and a presence in emerging markets. The Piramal deal comes on the heels of a smaller pact with Ahmedabad, India-based Zydus Cadila, which included 24 products sold in 15 emerging markets with the option to add 40 more products. Abbott says emerging markets already represents over 20% of its total business. The companies say the Indian pharma market is expected by 2015 to more than double from the roughly $8 billion in sales this year. With the addition of Piramal, which will have branded generics sales of about $500 million in 2011, Abbott’s Indian business is expected to grow nearly 20% per year, reaching annual sales of over $2.5 billion by 2020. “Emerging markets” have become the buzz words du jour at big pharma, as improving economies mean more people can afford medicines in countries like China, India, Brazil, and Russia. According to Burrill & Co, just 13% of the pharma world was in emerging markets in 2011, whereas forecasts suggest 50% of business will be in those markets by 2020. At the JPMorgan Healthcare conference this fall, most of the big players devoted a healthy portion of their face time with investors to discussing their strategy in those areas. As Sanofi-Aventis CEO Christopher Viehbacher noted at the time, more than 50% of growth in the drug industry will come from those regions. As a result, big pharma firms have been scrambling to establish partnerships that can swiftly get them on the ground in those countries. GSK has a broad deal with South Africa’s Aspen Pharmacare and a pact with India’s Dr. Reddy’s Laboratories. Pfizer has established pacts with several Indian firms, including Strides Arcolab, Aurobindo, and Claris Life Sciences. Sanofi-Aventis has bought Indian vaccines maker Shantha Biotechnics, and the Czech generics firm Zentiva. Even biotechs are starting to get into the game: earlier this year, Cephalon bought Swiss generics firm Mepha. For Piramal, the sale of the formulations business to Abbott appears to be part of...

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