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Published on 10/26/2006 in the Prospect News Biotech Daily.

Bristol-Myers Squibb negatively impacted by generic Plavix

By Lisa Kerner

Charlotte, N.C., Oct. 26 - Bristol-Myers Squibb Co.'s third-quarter 2006 net sales from continuing operations decreased 13% to $4.2 billion from the prior-year period. U.S. net sales were down 18% to $2.2 billion for the quarter, driven by the impact of generic Plavix (clopidogrel bisulfate) and the loss of exclusivity of Pravachol in the United States.

The at-risk launch of generic clopidogrel bisulfate cost the company an estimated $525 million to $600 million.

"Clearly, our third quarter overall performance was negatively impacted by generic competition to Plavix and the loss of exclusivity on Pravachol earlier this year," chief executive officer Jim Cornelius said in a company news release.

"However, our other major products continue to demonstrate robust, double-digit sales growth and the launches of our new products, Sprycel, Orencia and Baraclude are on track."

Worldwide pharmaceutical sales were down 17% to $3.2 billion in the third quarter of 2006, and U.S. pharmaceutical sales fell 22% to $1.6 billion from the same period in 2005.

Net earnings on a GAAP basis for the third quarter were down at $338 million, or $0.17 per diluted share, from $964 million, or $0.49 per diluted share for the same period in 2005.

Research and development expenses increased 13% to $756 million in the third quarter of 2006, from $669 million in the same period in 2005.

For the nine months ended Sept. 30, net sales from continuing operations decreased 3% to $13.7 billion compared to the first nine months of 2005.

Bristol-Myers reported net GAAP earnings from continuing operations in the first nine months of $1.7 billion, or $0.88 per diluted share, down from $2.5 billion, or $1.27 per diluted share, for the same period last year.

Company highlights for the quarter include the European Medicines Agency recommendation of a marketing authorization for Sprycel (dasatinib) for the treatment of chronic myeloid leukemia and Food and Drug Administration's approval of Abilify Injection to control agitation in bipolar mania.

Bristol-Myers Squibb also received FDA approval of a once-daily 300 mg single capsule formulation of Reyataz for the treatment of HIV-1 infection.

Management raised its 2006 full-year earnings guidance for fully diluted earnings per share from continuing operations on a GAAP basis to between $0.97 and $1.02, from no less than $0.95 following the at-risk launch of generic clopidogrel bisulfate.

Bristol-Myers Squibb is a health-care company based in New York.


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