Recently, Bristol-Myers Squibb Company (BMY - Analyst Report) and partner Pfizer Inc. (PFE - Analyst Report) announced that the US Food and Drug Administration (FDA) pushed back the originally assigned target date for their anti-clotting drug Eliquis (apixaban).
In November 2011, the US regulatory authority had announced that it will take a decision on the new drug application (NDA) for Eliquis by March 28, 2012. The companies submitted more data to the FDA subsequently. The regulatory body said that it has extended the target date by three months to June 28, 2012, as it needs more time to review the additional data. The NDA was filed in 2011.
Bristol-Myers and Pfizer are looking to get the candidate approved in the US for preventing strokes and systemic embolism in patients suffering from atrial fibrillation (AF). AF refers to a cardiac rhythm disorder characterized by an erratic heartbeat.
We remind investors that Eliquis was cleared in the EU last year for preventing venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery. However, the AF market is more lucrative and the drug is under review in Europe for the AF indication.
Since Eliquis offers multi-billion dollar sales potential, we believe if the candidate is approved for the AF indication then it would be a major boost for Bristol-Myers/Pfizer’s top line.
However, Eliquis would face intense competition in the anti-coagulant market on approval. Eliquis will have to compete with Bayer /Johnson & Johnson’s (BAYRY - Analyst Report) /(JNJ - Analyst Report) blood-thinner Xarelto. Moreover, the arrival of Boehringer Ingelheim’s Pradaxa has intensified competition in the market.
Currently, we have a long-term Neutral recommendation on Bristol-Myers, which carries a Zacks #3 Rank (short-term Hold rating). We have a similar stance on Pfizer.