Bristol-Myers Squibb looking stronger than expected

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Plavix (clopidogrel bisulfate), which prevents blood clots in patients at risk of heart attack or stroke and is the world's second biggest-selling prescription drug, loses US patent protection in November 2011. Bristol-Myers Squibb markets the drug in the US, while its partner sanofi-aventis sells it in other countries. Bristol-Myers got almost a third of its 2009 revenue from Plavix—Euros 4.6 billion out of a total of Euros 14.1 billion—and is racing to find new drugs to fill the gap.

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It has also been reported as unlikely that its psychiatric drug Abilify (aripiprazole) will face generic competition before 2015, and any legal challenge to Abilify patents is predicted to fail. This protects Bristol-Myers somewhat from the ‘patent cliff’ it might have fallen off in 2011.

New data shows Bristol-Myers' anticoagulant apixaban exceeded expectations in both safety and effectiveness in preventing strokes when compared to aspirin, making it one of the biggest opportunities in Bristol-Myers' late-stage pipeline.

"We see these data as placing apixaban clearly ahead of its potential competitors in the largest commercial potential market for these products," a Jefferies analyst wrote. He also had high expectations for the experimental cancer drug ipilimumab.

The FDA is giving ipilimumab a priority review as a treatment for advanced melanoma in adults who have received at least one previous therapy. That means the FDA will make a decision within six months of receiving the company's application instead of the usual 10 months. That could lead to a decision on approval by 25 December 2010.

Finally investigational drug dapagliflozin has behaved encouragingly in a phase 3 clinical trial in diabetes patients. Results from the study were presented at the 46th European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.

References

Bristol-Myers Squibb. Press Releases. AVERROES Study of Investigational Agent Apixaban Closes Early Due to Clear Evidence of Efficacy. 10 June 2010.

Bristol-Myers Squibb. Press Releases. Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma. 18 August 2010.

Bristol-Myers Squibb. Press Releases. 52-Week Phase 3 Study Found Investigational Drug Dapagliflozin Plus Metformin Similar to Glipizide Plus Metformin in Improving Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus. 24 September 2010.

It has also been reported as unlikely that its psychiatric drug Abilify (aripiprazole) will face generic competition before 2015, and any legal challenge to Abilify patents is predicted to fail. This protects Bristol-Myers somewhat from the ‘patent cliff’ it might have fallen off in 2011.

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