Last week, three biotech majors, Celgene (CELG), Biogen (BIIB) and Gilead (GILD) touched new 52-week highs as they continued to benefit from positive updates in the EU, announced in the previous week.
Orexigen Gains on LIGHT Data: Orexigen (OREX) presented positive interim data on its obesity candidate, Contrave, from the Light study last week. A goal set by the FDA was achieved in the study with no new safety signals materializing.
With the encouraging cardiovascular outcomes data in hand, Orexigen is set to seek FDA approval for Contrave, again (the FDA had refused to approve Contrave earlier), and could well be on the path to approval by Jun 2014. What makes this even more interesting is that the FDA had earlier refused to approve Contrave due to concerns regarding the candidate’s cardiovascular safety profile.
The Light data will also come in handy in answering any questions that may be posed by the EU regulatory authorities where Contrave is currently under review.
Shares were up 9.3% immediately after the data was released and up 20% by the end of the week. The Light data means a lot to Orexigen which will most likely be the third entrant in the obesity market in recent times. Belviq and Qsymia, two recently launched drugs, are yet to make a mark in the highly lucrative obesity market.
Contrave, with its efficacy profile and the Light data, could well become a success story in the obesity market. Currently, chances of gaining FDA approval by June look pretty good, and partner Takeda is already preparing for commercialization. An additional bonus would be EU approval, potentially in the second half of 2014, where Belviq and Qsymia are yet to be approved. There could also be more partnership deals round the corner.
So Orexigen has a lot going for it – possible regulatory approvals, extensive data, a strong marketing partner, additional partnership deals – this is definitely a stock to watch out for.
Cubist Hits 52-Week High: Shares of Cubist (CBST) jumped 8% with the company reporting promising phase III data on its experimental antibiotic - ceftolozane/tazobactam for complicated urinary tract infections. Ceftolozane/tazobactam met the primary endpoint of statistical non-inferiority compared to levofloxacin. In fact, even though the study was not conducted to demonstrate superiority, results indicated statistical superiority over levofloxacin.
The safety profile also looked fine and was consistent with earlier studies. Up next is data from a phase III study in patients with complicated intra-abdominal infections – this should be out later this month and expectations are high for positive results.
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The Week So Far:
OncoMed Shoots Up on Celgene Deal: Biotech major Celgene inked a deal with OncoMed (OMED) for the joint development and commercialization of up to six anti-cancer stem cell candidates from OncoMed's biologics pipeline. OncoMed shares jumped 97.9% on the news. The deal is a major achievement for OncoMed which went public earlier this year in July.
Conatus Gains on Orphan Drug Status: Shares of Conatus Pharmaceuticals were up 18.1% after the FDA granted Orphan Drug Status to experimental drug, emricasan.
Lexicon Slips on Phase II Data: Lexicon Pharmaceuticals' (LXRX) pipeline candidate, LX1033, failed to achieve statistical significance in the primary endpoint of a phase II study for diarrhea-predominant irritable bowel syndrome (IBS-d). Shares were down 4.7%.
Gilead's Patent Issues: Gilead is facing a couple of lawsuits regarding its experimental hepatitis C drug, sofosbuvir. Idenix Pharmaceuticals is claiming that the candidate infringes its patents. The lawsuits come just a few days ahead of the FDA action date for sofosbuvir (Dec 8), when approval is largely expected.
Biogen Faces Another Delay: The FDA action date for Biogen’s hemophilia B candidate, Alprolix, has been pushed back by three months, which means the company will most likely be able to launch Alprolix later in the first half of 2014 provided it gains approval. This is the second delay being faced by Biogen where its hemophilia pipeline is concerned.
Later this week, the FDA is slated to deliver a decision on Auxilium Pharma’s Xiaflex for the Peyronie’s disease indication and on Gilead’s sofosbuvir. Both are binary events to watch out for.
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