How will it manage such a feat? Through growth of its drugs still under patent, perhaps a few cost-cutting measures, and of course, development of new drugs in its pipeline. As of its last update, the company has six drugs in phase 3 development on their way toward a regulatory decision, but that doesn't include already-approved drugs for which Bristol-Myers is trying to expand into additional territories or indications.
Here's a look at the five drugs that investors should keep their eyes on because, if all goes well, they're scheduled to launch before the end of 2012. If they don't pan out, Bristol-Myers will have a hard time growing post-Plavix.
A holiday present from the FDA?
Bristol-Myers has already submitted to the Food and Drug Administration its application to market cancer drug ipilimumab, which has set Dec. 25 as the target date for giving its decision. The agency doesn't work its employees hard enough to require them to come in on Christmas, so expect an approval a little early or potentially after the PDUFA goal.
The latter might be more likely considering that the data for ipilimumab, which treats melanoma (skin cancer), is a little confusing. The trial didn't have a placebo control and instead compared ipilmumab, another drug -- a gp100 peptide vaccine -- and a combination of the two. Working in ipilimumab's favor, metastatic melanoma is one tough cancer to treat, with few options. Ipilimumab seems to improve survival on its own, which might be enough to get the drug approved regardless of the confusing treatment arms.
Starting off small
Bristol-Myers has pegged brivanib as a liver cancer drug because that's the first indication where we'll see a result, but the drug is being tested for a range of cancer types. It's the same strategy that Pfizer
It's a bit of a crap shoot to guess whether the drug will pass its phase 3 trial in liver cancer, but keep in mind it's not the end of the world if it fails. There are plenty of drugs that work well in one cancer type but not another.
A duos do-over
Bristol-Myers and AstraZeneca's
But the duo gets a do-over with dapagliflozin, which works under a different mechanism and won't have the "me too" stigma attached to it. The drug looked good in the phase 3 trial presented at the American Diabetes Association annual meeting this year, but that was as an add-on therapy. The true test is whether it can go head to head against drugs currently on the market. The diabetes market is getting crowded with new GLP-1 drugs from Novo Nordisk, and Eli Lilly
Second time's the charm
Bristol's transplant drug belatacept should get a second chance at approval after it was rejected by the FDA earlier this year. A panel of outside experts voted 13-5 recommending approval of the drug, but the agency decided it wanted to see three-year safety data rather than the two years' worth of data that the company had at the time of submission.
Unless something new crops up, it looks like belatacept shouldn't have any problems getting past the FDA on its second attempt.
50 years in the making
Of the drugs in Bristol's late-stage pipeline, Apixaban might have the best chance at becoming a blockbuster because it treats an unmet need. Unfortunately, Bristol-Myers will have to share profits with its marketing partner, Pfizer.
The blood thinner has the potential to unseat warfarin, which was originally developed by Bristol-Myers in the 1950s as Coumadin. Warfarin is problematic because it has a low therapeutic window in which it works. Too much is dangerous -- it's the active ingredient in some rat poisons -- and too little won't help prevent heart attacks.
Apixaban was able to prevent stokes in patients better than aspirin, but the true test -- scheduled to be completed next year -- is whether it works better than warfain. Pass that test and apixaban should be home free.
We have a winner ... hopefully
Bristol-Myers clearly has a strong pipeline for its size and substantial cash in the bank to add to it. Success isn't guaranteed -- investors are still taking on risk by investing -- but the rewards should make the risk worth it.
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