Recently, Bristol-Myers Squibb Company (BMY) announced that the US Food and Drug Administration (FDA) has approved an update to the label of the pharma major’s human immunodeficiency virus (HIV) therapy Reyataz (atazanavir sulfate). The updated label will include dose recommendations for pregnant women infected with HIV.
The update to Reyataz’s label was approved based on data from a multicenter, open-label, single arm, pharmacokinetic study. The study evaluated 41 HIV infected women, who were between 12 and 32 weeks pregnant. Bristol-Myers emphasized that Reyataz should always be used in conjunction with ritonavir during pregnancy.
The most preferred dose is 300 mg Reyataz combined with 100 mg ritonavir. The combination resulted in minimum plasma concentrations (24 hours post-dose) during the final 3 months of pregnancy. This was comparable to what was observed in adults infected with HIV.
The company further revealed that concentrations of Reyataz may be raised during the postpartum period (post-delivery). All pregnant women should be monitored carefully for increases in side effects during the postpartum period.
Bristol-Myers further cautioned that Reyataz should be used during pregnancy only if the benefits associated with the usage outweighed the risks involved and the virus is susceptible to treatments by Reyataz. The company further stated that the drug should not be used without ritonavir for treating pregnant women or those in the postpartum period.
The update to the label of Reyataz, approved in 2003 as a combination therapy with antiretroviral agents for treating patients at least six years of age, provides proper guidance regarding the usage of Reyataz and prevents its abuse. The updated label should go a long way in promoting the well-being of HIV infected pregnant women and those in the postpartum period.
Our Take & Recommendation
Bristol-Myers currently carries a Zacks #4 Rank (short-term Sell rating). Our biggest concern for the company is the high exposure to generic risk on many of its leading franchises.
Bristol-Myers lost patent protection on products worth about $4 billion over the past few years. The loss of exclusivity of key drugs including the blockbuster Plavix will result in significant loss of revenues for Bristol-Myers. Plavix is scheduled to go off patent on May 17, 2012 with the FDA granting an additional 6-month market exclusivity period to Bristol-Myers and partner Sanofi-Aventis (SNY).
However, we are Neutral on Bristol-Myers in the long-term. The more stable long-term outlook is based on measures taken by Bristol-Myers like the extension of the Abilify agreement with Otsuka, the acquisition of ZymoGenetics and Medarex to combat the looming threat of generics. Moreover, the company intends to launch five compounds — apixaban, belatacept, brivanib, dapagliflozin and ipilimumab by 2012.
Given the present scenario, we believe the ipilimumab launch could occur before 2012. The new launches are expected to drive growth in 2013 and beyond. We expect the company to look to grow revenue through partnering deals and acquisitions.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
Zacks Investment Research
