Readers Pick Drug Approval Winners & Losers

BOSTON (TheStreet) -- The opioid addiction drug from Alkermes ALKS is a lock for U.S. approval later this month, as are a new diabetes drug from Amylin Pharmaceuticals AMLN and partners and an antibiotic made by Forest Labs FRX. The respective weight-loss drugs from Arena Pharmaceuticals ARNA and Vivus VVUS, however, stand almost no chance of receiving the backing of U.S. drug regulators. Those are some of the consensus opinions that stand out from 80 readers (so far) who submitted entries to TheStreet's FDA Drug-Approval Contest. I spent part of my weekend number crunching your predictions and came away with results that I'd say largely encompass broader investor expectations with some exceptions. Let's start with the consensus favorites: Alkermes tops the list, with 84% of readers predicting full approval for Vivitrol opioid, the company's once-monthly injectable drug to treat opioid addiction. That's an overwhelming consensus but perhaps not surprising given the positive recommendation for Vivitrol's approval from an FDA advisory panel on Sept. 16. The FDA is expected to make its approval decision known on Oct. 12. If you believe in the efficiency of markets, then Alkermes' stock price already bakes in Vivitrol's approval, although perhaps not the drug's commercial potential. Readers were equally decisive, albeit in the other direction, about the weight-loss drugs currently under review at the FDA. By margins of 85% and 80%, respectively, readers believe FDA will issue complete response letters to Arena Pharmaceuticals and Vivus. That readers expect FDA to hold off on approving these obesity drugs isn't surprising given the negative votes from the U.S. advisory panels that reviewed Arena's lorcaserin and Vivus' Qnexa. The beaten-down stock prices of both Arena and Vivus certainly mirror these sentiments already. To read the rest, head over to TheStreet.com