Recently, Bristol-Myers Squibb Company (BMY) presented encouraging data from a phase II study (n=48) which evaluated its candidate BMS-790052 in combination with peginterferon and ribavirin (standards of care) for treating patients suffering from the hepatitis C virus (HCV). Bristol-Myers presented data from the mid-stage study at the 51st interscience conference on antimicrobial agents and chemotherapy held in the US.
The double-blind study evaluated BMS-790052 at three doses (3 mg, 10 mg or 60 mg) in treatment-naïve patients infected with genotype 1 chronic HCV. Results from the study revealed that the rate of SVR24 (sustained virologic response – absence of detectable HCV at 24 weeks post treatment ) achieved by patients treated with a combination of BMS-790052, PEG-interferon alfa and ribavirin was higher across all evaluated doses than those receiving placebo in combination with PEG-interferon alfa and ribavirin. The patients were divided equally into four groups.
Patients in the 10 mg and 60 mg arms of BMS-790052 achieved the highest rate (83% each) of SVR24. 42% patients achieved SVR24 in the 3 mg arm. Only 25% patients achieved SVR24 in the placebo arm. Encouraged by the positive mid-stage data, Bristol-Myers has moved the candidate into late-stage studies.
We believe that if BMS-790052 is developed and commercialized successfully then it would not only boost Bristol-Myers’ portfolio but would provide a wider choice to HCV patients in a lucrative market that has a huge unmet need.
Chronic HCV infection is a leading cause of cirrhosis, liver failure and hepatocellular carcinoma across the globe. It is estimated that approximately 170 million people are affected by HCV across the globe. We note that Vertex Pharmaceuticals Inc.'s (VRTX) Incivek and Merck & Co.’s (MRK) Victrelis, were approved in the US for HCV earlier in the year.
Our Take & Recommendation
We currently have a Neutral recommendation on Bristol-Myers. The stock carries a Zacks #3 Rank (short-term Hold rating). Our biggest concern for the company is the high exposure to generic risk on many of its leading franchises including the block-buster Plavix.
Bristol-Myers has co-developed Plavix with Sanofi-Aventis (SNY). Bristol-Myers is looking to expand via acquisitions and partnerships to counter the loss of revenues that would arise following the genericization of its key drugs.
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