Recently, Bristol-Myers Squibb Company (BMY) presented encouraging data from a phase II study (n=48) which evaluated its candidate BMS-790052 as a combination therapy for treating patients suffering from the hepatitis C virus (HCV). Bristol-Myers presented data from the mid-stage study at the 46th annual meeting of the European Association for the Study of the Liver in Germany.

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 SVR12 (sustained virologic response – absence of detectable HCV at 12 weeks post treatment ) achieved by patients treated with a combination of BMS-790052, PEG-interferon alfa and ribavirin (the standard of care) 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 arm achieved the highest rate (92%) of SVR12.  83% and 42% patients achieved SVR12 in the 60 mg and 3 mg arms of BMS-790052 respectively. Adverse events and serious adverse events were found to be consistent with those in the PEG-Interferon alfa and ribavirin arm across all 3 doses of BMS-790052.

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.

Our Take & Recommendation

We currently have a Neutral recommendation on Bristol-Myers, which is supported by 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, which has been co-developed with Sanofi-Aventis (SNY).

However, Bristol-Myers has already taken measures like the extension of the Abilify agreement with Otsuka, the acquisition of ZymoGenetics and Medarex to combat the threat of generics hanging over it. The approval of ipilimumab in the US is a big boost for the company and will bolster its top line.

Bristol-Myers intends to launch four more compounds – apixaban, belatacept, brivanib and dapagliflozin – by 2012. The new launches are expected to drive growth in 2013 and beyond. We also expect Bristol-Myers to grow revenues through partnering deals and acquisitions.

 
BRISTOL-MYERS (BMY): Free Stock Analysis Report
 
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
 
Zacks Investment Research