Will These Drugs Get Past the FDA?

Ahhh, March. The month where office betting -- sanctioned or not -- hits its peak for the year as NCAA pools dominate water cooler discussions. It also brings another month of potential rewards for drug companies and their investors as the Food and Drug Administration makes decisions about marketing applications.

Let's take a look at who's hoping to score at the big dance this month.

The opening tip
The FDA agreed to give Novartis' (NYSE: NVS  ) cancer drug everolimus a priority review last September, resulting in a PDUFA date this month. Everolimus is up for approval in kidney cancer patients after they've failed current treatments like Onyx Pharmaceuticals' Nexevar and Pfizer's (NYSE: PFE  ) Sutent.

A second-line treatment label isn't going to make the drug, which will be sold under the brand name Afinitor, a blockbuster, but this is just the opening tipoff for the drug. It's also in trials for a range of other cancers including breast and lung cancer, which are much larger markets.

Given the unmet need and that the trial was stopped early because the drug was clearly working when the independent data monitoring committee took an interim peek, chances look good that the FDA gives the drug the green light. Everolimus is also the drug part of the drug-eluting stents sold by Abbott Labs (NYSE: ABT  ) and Boston Scientific, which could give it a slight advantage toward approval as FDA reviewers are at least a little familiar with the molecule -- albeit in a different context.

Cinderella story?
Tiny Dyax (Nasdaq: DYAX  ) is like one of those 16-seed schools: It snuck into the tournament with an automatic bid, but it's still facing an uphill battle from here.

In February, an FDA advisory committee voted six to five in favor of Dyax's hereditary angioedema (HAE) treatment, ecallantide -- not exactly a vote of confidence. The committee is worried about allergic reactions to the drug, which treats the acute attacks of swelling caused by HAE.

Even if the FDA gives Dyax a thumbs up on its PDUFA date of March 23, it'll still have strong competition in the second -- marketing -- round. Viropharma's (Nasdaq: VPHM  ) Cinryze was recently approved as a prophylactic for HAE and both Cinryze and CSL Behring's Berinert-P, which is already approved in other countries, are up for review at the FDA for treating acute episodes of HAE.

It's not impossible for Dyax to pull out an upset, but don't count on it.

The 6th man
If chemotherapy treatments make up the starting roster for the treatment of cancer then GlaxoSmithKline's (NYSE: GSK  ) Rezonic is the 6th man waiting to step in. The drug is used to prevent nausea and vomiting induced by treatment with chemotherapy.

In its clinical trials, Rezonic substantially reduced vomiting when added to Zofran and a generic drug called dexamethasone. Glaxo already sells Zofran for the prevention of chemotherapy-induced vomiting, but since Rezonic is an add-on treatment, an approval shouldn't affect sales of Zofran.

While there's always the possibility of the FDA issuing a complete response letter over a minor issue, it looks like Glaxo's investors won't experience any gut wrenching decisions this month.

Play in game
There are a couple of drugmakers hoping for a little March madness even though they don't have an invitation -- in the form of a March PDUFA date -- to the big dance.

Left over from last month's list, Eli Lilly (NYSE: LLY  ) still has a pending application with the FDA for prasugrel. The company had a positive FDA panel meeting for its drug in February, but hasn't gotten a final ruling from the FDA. Eli Lilly and Amylin Pharmaceuticals are also waiting for an expansion of their diabetes drug Byetta as a monotherapy.

Novo Nordisk has a PDUFA date of March 23 for its diabetes drug liraglutide, but we can pretty much be certain that the company won't get an invitation to the big dance this month. The FDA scheduled an advisory panel meeting for the beginning of April, so Novo Nordisk won't get a decision until after that.

Place your bets?
Sometimes buying shares in drugmakers can feel more like betting than investing. The binary outcomes of clinical trials and FDA decisions mimic those of sporting events and the recent FDA delays can be as gut wrenching as watching your favorite team go into overtime.

The trick is to find events where you believe a positive outcome is more likely than other investors are giving the drug credit for. And of course spreading your investments around to multiple, well-selected companies can balance out the risk. The Motley Fool Rule Breakers newsletter has a few recommendations. You can grab a 30-day trial subscription and see them for free.

Novo Nordisk is a Global Gains picks. GlaxoSmithKline is a current and Pfizer is a former pick of the Income Investor newsletter. Pfizer is an Inside Value pick.

Fool contributor Brian Orelli, Ph.D., didn't go to a division one school for undergrad or graduate school and wonders who to root for every March. He doesn't own shares of any company mentioned in this article. The Fool's disclosure policymakes its NCAA pool picks based on which mascot would win a grudge match.


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