Last week was eventful for the biotech sector with highlights including a couple of FDA approvals (Xtandi’s label expansion and Contrave) and a positive FDA panel outcome (Natpara). However, the biggest gainer was Avanir Pharmaceuticals ( AVNR ), which came out with positive phase II data for the treatment of agitation in patients with Alzheimer’s disease. Shares were up 85.3%.
Overall, the NASDAQ Biotechnology Index gained 0.55% last week. Avanir’s shares shot up on positive data from a phase II study conducted with AVP-923 for the treatment of agitation in patients with Alzheimer’s disease. Considering the lack of FDA approved drugs for the treatment of agitation in Alzheimer’s disease, there could be significant demand for AVP-923 once it is approved.
NPS Pharmaceuticals’ ( NPSP ) Natpara came up before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee last week. The FDA’s advisory panel voted 8 – 5 in favor of approving Natpara for the long-term treatment of hypoparathyroidism. A final response from the FDA should be out by Oct 24. However, with the panel raising some concerns, chances remain that the FDA action date could get delayed.
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Orexigen ( OREX ) finally received FDA approval for its obesity drug, Contrave. Focus will now be on the commercialization of the drug. Partner Takeda’s marketing muscle should come in handy. Meanwhile, approval should also make it easier for Orexigen to find a partner for ex-North American territories.
Another company that gained FDA approval last week is Medivation(MDVN). With this approval, Medivation’s prostate cancer treatment, Xtandi, can now be used in the pre-chemo patient population as well.
Gilead ( GILD ) will be selling its high-priced hepatitis C virus (HCV) treatment, Sovaldi, at a huge discount in developing countries. Not just Sovaldi but a combination treatment comprising Sovaldi and ledipasvir which is currently under review will also be provided in these countries which are estimated to account for about 54% of the total global infected population (read more: Gilead (GILD) Slips on Generic Sovaldi Licensing Deals ).
Amarin Corporation’s ( AMRN ) shares were down on news that the FDA’s Office of New Drugs denied an appeal filed by Amarin related to the FDA’s rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement
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Gilead was the biggest loser among the big biotechs last week with its shares declining 1.07%, reflecting concerns regarding the company’s decision to sell Sovaldi at a significant discount in developing countries. Celgene ( CELG ) also lost some ground with shares declining 0.39%.
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