Investors are ecstatic about Dendreon's (Nasdaq: DNDN ) win last week. Shares jumped 35% last week after the mid-Thursday approval announcement.
I'm in the "that's great, but …" camp. It's time to move on to other news. Two drugs also received late-week decisions from the Food and Drug Administration, and another is scheduled to hear this week.
On Friday, the FDA approved Vimovo, an arthritis drug from Pozen (Nasdaq: POZN ) and AstraZeneca (NYSE: AZN ) . Pozen is trading flat on the news, but it's up 72% year to date, so there's probably a bit of selling on the news.
Vimovo is a combination of painkiller naproxen and AstraZeneca's heartburn drug Nexium. Non-steroidal anti-inflammatory drugs (NSAIDs) -- such as Advil and Celbrex from Pfizer (NYSE: PFE ) , and naproxen, the active ingredient in Bayer's Aleve -- can be hard on the stomach. Nexium is there to counteract that side effect.
Vimovo won't be in the same class of sales as Dendreon's Provenge; the latter should have no problem hitting blockbuster status, while Vimovo might be lucky to get $300 million in sales, according to one analyst. But with a market cap that's less than one-twentieth the size of Dendreon, Pozen doesn't exactly need sales to be that high.
Bristol-Myers Squibb (NYSE: BMY ) also got a decision from the FDA, but it wasn't the positive kind. The agency wants three-year data from clinical trials investigating belatacept, which helps avoid rejection of transplanted kidneys. Investors knew the agency had some concerns over the two-year safety data that supported the application, but I figured the 13-to-5 vote by the advisory panel recommending approval would have been enough to sway the agency's reviewers. Guess not.
Looking ahead, tomorrow is InterMune's (Nasdaq: ITMN ) PDUFA date for pirfenidone, which treats idiopathic pulmonary fibrosis (IPF). The FDA isn't bound by that date -- it could come early, as in Dendreon's case, but I wouldn't be surprised by a delay given the complexity of the case. Pirfenidone, which will go by the trade name Esbriet, only passed one of its two phase 3 trials, but it treats a disease that currently doesn't have any good treatment options.
Given the amount of uncertainty over what the FDA will do about pirfenidone, I expect InterMune's shares price could increase a lot more than Dendreon's 35% jump after the decision is handed down.
You're likely to hear a lot more about Dendreon in the coming months: its first treated patient, updates on its new manufacturing plant, potential suitors, and the list goes on. Read the press releases and articles, especially if you're a shareholder. Just don't forget that there's plenty of money to be made in biotech outside of Dendreon, too.