Orexigen Gets Review Date For Obesity Drug Candidate Contrave
Jun17

Orexigen Gets Review Date For Obesity Drug Candidate Contrave

We now have the final FDA review deadline date for all three of the biggest contestants in the obesity drug race. Today Orexigen Therapeutics announced that FDA has assigned a January 31, 2011 Prescription Drug User Fee Act (PDUFA) date for the firm’s obesity drug candidate, Contrave. This is right about when people expected the date would be, given that Orexigen filed for the drug's approval back in April. The PDUFA date is the goal date for FDA to finish reviewing the company’s new-drug application. This is when folks will be watching for approval decisions. Orexigen's two biggest competitors are Arena's lorcaserin and Vivus's Qnexa. Both of the other drugs' FDA review deadlines are in October of this year. But as we've written before, if you're first to the finish line, you don't have the opportunity to learn from what came before. This is the part where I say "let's not get carried away, here": Anywhere from zero to all three of these experimental drugs could be approved by FDA. It's all about the balance between efficacy and safety. And none of the three companies developing the drug candidates has found a bigger company to partner with them on the project. Though the big companies might be waiting for a bit more clarity on the drugs' approvability, as Leerink Swann analyst Steve Yoo said in a note to investors last March. More reading on Orexigen...

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Arena Raises More Cash For Obesity Drug Efforts
Jun03

Arena Raises More Cash For Obesity Drug Efforts

Arena Pharmaceuticals has said that if it can't find a partner for bringing its experimental obesity drug lorcaserin to market, it plans to go it alone. Today the company announced a deal that will give them $35.5 million, which will certainly help should that come to pass. The agreement is with Deerfield Management Company, a privately owned hedge fund sponsor that mainly invests in the healthcare area. This is good news for Arena, Leerink Swann analyst Steve Y. Yoo said in a report to investors. The influx of funds should allow Arena to operate into the 2nd quarter of 2011 without any further financing, he says. This funding might also come in handy because FDA's endocrinologic and metabolic division, which will evaluate lorcaserin, is in for a busy October, Yoo adds. Not only is another experimental obesity drug, Vivus's Qnexa, on the docket, there are two other drug candidates to be dealt with as well. Minor delays in the regulatory process might crop up because of this backlog, he says, and the funding provides a cushion for Arena in case delays do happen. However, Yoo says that "the best source of funding, in our view, would be an upfront payment by a partner for lorcaserin." But will that happen? Adam Feuerstein, senior columnist at TheStreet., doesn't think so, and he's not holding out hope for Arena's competitors in the obesity drug race either. On Twitter (@adamfeuerstein) this morning he wrote: $ARNA raises more $ thru Deerfield. WIll $VVUS, $ARNA or $OREX partner before FDA panels/approval decisions? Looking increasingly unlikely. And in other Arena news: Yesterday the company announced that the FDA advisory panel will discuss lorcaserin on September...

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