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Bristol Erbitux: Colorectal Refiling Within 9 Months; Broader Package In 2004

Executive Summary

Bristol-Myers Squibb could refile Erbitux in irinotecan-refractory colorectal cancer by July, Exec VP Donald Hayden told the Bear Stearns healthcare conference in New York City Sept. 17

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Tidbits From First Quarter Conference Calls, In Brief

GSK Wellbutrin SR generics: Difficulty in manufacturing Wellbutrin SR likely to stall generic competition for bupropion extended-release, GlaxoSmithKline CEO J.P. Garnier says April 30. "This product is not that easy to copy. In fact, the SR is a fraction easier; the XL is really tough." Blend uniformity problems have prevented approval of Andrx' ANDA; those issues are said to have been resolved (1"The Pink Sheet" July 15, 2002, p. 7)....Andrx bupropion delay: Andrx is "communicating" with FDA regarding a specification change that affects expiration dating of its Wellbutrin SR generic, CEO Richard Lane says April 30. "Since learning of this issue, we have worked diligently to remedy the situation," he says. "We are unable to predict when and if this issue will be resolved satisfactorily and these products launched." Andrx is also awaiting D.C. court decision on GSK's appeal of non-infringement ruling (2"The Pink Sheet" Dec. 9, 2002, p. 28)....

Tidbits From First Quarter Conference Calls, In Brief

GSK Wellbutrin SR generics: Difficulty in manufacturing Wellbutrin SR likely to stall generic competition for bupropion extended-release, GlaxoSmithKline CEO J.P. Garnier says April 30. "This product is not that easy to copy. In fact, the SR is a fraction easier; the XL is really tough." Blend uniformity problems have prevented approval of Andrx' ANDA; those issues are said to have been resolved (1"The Pink Sheet" July 15, 2002, p. 7)....Andrx bupropion delay: Andrx is "communicating" with FDA regarding a specification change that affects expiration dating of its Wellbutrin SR generic, CEO Richard Lane says April 30. "Since learning of this issue, we have worked diligently to remedy the situation," he says. "We are unable to predict when and if this issue will be resolved satisfactorily and these products launched." Andrx is also awaiting D.C. court decision on GSK's appeal of non-infringement ruling (2"The Pink Sheet" Dec. 9, 2002, p. 28)....

Erbitux expanded access program

National Organization for Rare Disorders is administering expanded access program for Bristol-Myers Squibb/ImClone's Erbitux (cetuximab) for metastatic colorectal cancer patients ineligible for clinical trials. Thirty patients per month will be randomly selected to participate. The program began Feb. 6 in 20 cancer centers and will continue until thirty days after approval. Bristol expects to file a "comprehensive" Erbitux package with FDA in 2004 (1"The Pink Sheet" Sept. 23, 2002, p. 6)...

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