Investors are all jazzed up about Jazz Pharmaceuticals
The drug that treats debilitating pain seems to be on the right path. The documents conclude that the company "provided sufficient evidence to support the efficacy" of the drug. It doesn't get much better than that.
But Jazz isn't going to scoot by too easily, either. There's one committee member who gives a big clue into the only issue standing between Jazz and an approval: Cynthia Morris-Kukoski, who works for the FBI.
What's the FBI doing on an FDA advisory panel? JZP-6 is related to the "date rape" drug GHB. The FDA -- and the FBI for that matter -- wants to make sure the drug isn't abused. Jazz is well aware of the issues -- it already sells JZP-6 as a treatment for narcolepsy -- but it needs to convince the panel that it has the appropriate risk plan in place for the new indication, which will greatly increase the number of potential patients.
The FDA is also worried about Jazz's plan to market JZP-6 as Rekinla for fibromyalgia and Xyrem for narcolepsy. I don't see this as that big of deal -- Pfizer's
The tallest hurdle is likely to come after an approval. Added restrictions, including having the drug only available from specialty pharmacies, will be inconvenient for doctors and patients. The added issues won't be enough to stop patients who haven't received help from current offerings such as Eli Lilly's
Still, at a market cap of under $450 million even after today's run-up, investors don't seem to be expecting all that much from the additional indication. Let's just say they got jazzed up by the perfect amount and are certainly not abusing the valuation.
Alyce Lomax goes back-to-school shopping with today's "11 O'Clock Stock."
Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is a Motley Fool Inside Value choice. GlaxoSmithKline is a Motley Fool Global Gains recommendation, and the Fool owns shares. Plus, there's your friendly neighborhood disclosure policy.