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'
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
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
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
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
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.