Jazz Pharmaceuticals (Nasdaq: JAZZ ) investors went from ecstatic to devastated in less than a week.
The drugmaker is down more than 20% today, after Friday's Food and Drug Administration advisory committee meeting voted 20 to 2 against FDA approval of Jazz's JZP-6, for treating fibromyalgia. News doesn't get much worse than that.
Some of the experts on the panel were worried about the safety and efficacy of the drug, but the main concern was the same issue investors knew about going into the meeting. The drug's potential for abuse has to be taken into consideration. Jazz thought it had the issue under control with its proposed Risk Evaluation and Mitigation Strategies (REMS), but the panel clearly didn't think the REMS was strong enough.
So where does this leave Jazz? It seems inevitable that the company will get a complete response letter from the FDA, telling the company what it needs to do to gain approval. The only question now is whether the request will focus solely on the REMS, or whether the FDA will request additional studies. If the REMS is the only holdup, Jazz could probably resubmit the response two to three months after it hears from the FDA, which will probably occur in October. Add six months for the FDA to review the new packet, and assuming the FDA approves, Jazz could have the drug on the market in the middle of next year.
A new trial, on the other hand, would push back any launch much further. Considering that the FDA review materials were fairly positive about the drug's efficacy, and that it's already approved to treat narcolepsy, it seems less likely that the FDA would request a new trial, though this isn't impossible. Working against the company, there are several other options for fibromyalgia patients: Pfizer's (NYSE: PFE ) Lyrica, Eli Lilly's (NYSE: LLY ) Cymbalta, and Savella from Forest Labs (NYSE: FRX ) and Cypress Bioscience (Nasdaq: CYPB ) .
Jazz was a high-risk high-reward investment going into the advisory committee meeting. Until we hear exactly what the FDA wants, it'll remain that way.
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