(BMY) Bristol-Myers Squibb Company Gets Another Feather in its Cap

Bristol-Myers Squibb Company’s (BMY) product portfolio was boosted further when the US Food and Drug Administration (FDA) approved its drug Nulojix (belatacept) to prevent the rejection of transplanted kidneys in adults.

We remind investors that Bristol-Myers has succeeded in getting the drug approved in the US for the indication in its second attempt. In the second quarter of 2010, the FDA issued a complete response letter in response to biologic license application (BLA) submitted by the pharma major for Nulojix , asking for additional information. Subsequently, Bristol-Myers submitted it.

In December 2010, the agency had thereby announced that it would review the re-submitted application by June 15, 2011 (action date). The agency cleared the drug following the review thereby delivering a further boost to the company.

We note that the European approval of the drug for the same indication is on track. In April 2011, Bristol-Myers announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion and recommended approval of the drug in the European Union (EU).

We note that apart from Nulojix, some other major drugs of Bristol-Myers too have got cleared by the regulatory authorities this year. In March 2011, skin-cancer drug Yervoy was approved by the FDA and launched in April. Yervoy is under review in the Europe.

Moreover, in May 2011 the European Commission cleared Bristol-Myers’ blood-thinner Eliquis (apixaban) in the EU for preventing venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery. Bristol-Myers has co-developed Eliquis with Pfizer (PFE).

We note that Bristol-Myers has two more key action dates coming up this year. The FDA is scheduled to decide by August 4, 2011, on a subcutaneous formulation of Orencia for treating adults suffering from moderate-to-severe rheumatoid arthritis.

Furthermore, the US regulatory body is expected to decide on dapagliflozin, co-developed with AstraZeneca (AZN), for treating adults suffering from type II diabetes by October 28, 2011.

Bristol-Myers is looking to strengthen its product portfolio by launching new drugs to make up for the loss of revenues that is feared on the impending genericization of key drugs at Bristol-Myers, including the blockbuster blood-thinner Plavix. Plavix has been co-developed with Sanofi-Aventis (SNY).

Our Recommendation

We currently have a Neutral recommendation on Bristol-Myers in the long-run. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.

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