Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotechnology & Drugs -- Ignore unavailable to you. Want to Upgrade?

To: 2MAR$ who wrote (213)	11/25/2003 10:07:21 PM
From: 2MAR$	Read Replies (1) \| Respond to of 232

yet--->Genentech Expects Avastin Approval Tuesday November 25, 6:48 pm ET By Ransdell Pierson DNA chart again: stockcharts.com[h,a]waclyyay[pb50!b200][vc60][iUc20!La12,26,9]&pref=G NEW YORK (Reuters) - Genentech Inc. said on Tuesday its Avastin cancer drug failed to meet its primary goal of prolonging survival in a mid-stage trial of patients with metastatic colorectal cancer, but the company still expects U.S. approval of the drug next year. ADVERTISEMENT Genentech (NYSE:DNA - News), which in September asked U.S. regulators to approve Avastin as a first-line treatment for metastatic colorectal cancer in combination with chemotherapy, said it expects approval by the end of the first quarter of 2004 despite Tuesday's setback. The biotech firm, based in South San Francisco, California, said the Phase II trial involved 209 patients who had not been previously treated for metastatic colorectal cancer, meaning tumors that have spread to other parts of the body. They took Avastin along with commonly used chemotherapy drugs 5-FU and Leucovorin. Although patients taking the combination treatment saw a 29 percent improvement in overall survival, compared with those who took 5-FU and Leucovorin alone, that fell short of the trial's main goal. The study also showed that patients taking Avastin, on average, took 67 percent longer to develop a worsening of their condition -- a result that was highly statistically significant, although it was not a primary goal of the study. The company's U.S. marketing application for Avastin was based on a separate 900-patient Phase III trial in which it was also used in combination with chemotherapy. The combo therapy prolonged median survival of patients about five months, or more than 30 percent longer than patients treated with chemotherapy alone. Bear Stearns analyst Hayley Xuereb said patients in the successful Phase III trial also took Avastin in combination with 5-FU and Leucovorin, as well as a very toxic third chemotherapy drug called irinotecan that was not used in the smaller Phase II trial. "Genentech wanted to see if they could still get good results without using irinotecan, but the results weren't as good as they had hoped," Xuereb said. She said the failed Phase II trial should not hurt Avastin's chances of being approved, however, because it was independent of the data being submitted to the FDA. Moreover, Xuereb said Avastin performed as well as expected when used with all three chemotherapy drugs in the big pivotal trial. Shares of Genentech fell to $83 on the Instinet electronic brokerage system from a close of $84.37 Tuesday on the New York Stock Exchange (News - Websites) . Even so, the stock remains up about 150 percent for the year to date, thanks largely to optimism that Avastin will be approved and will become a blockbuster treatment. The drug blocks a protein called vascular endothelial growth factor that promotes growth of blood vessels to tumors.