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

Genentech reports unrestricted cash and investments of $4.0 billion for third quarter

By Jennifer Lanning Drey

Portland, Ore., Oct. 10 - Genentech, Inc.'s unrestricted cash and investments portfolio totaled approximately $4.0 billion at Sept. 30, down from $4.2 billion at Dec. 30, 2005, David Ebersman, Genentech's chief financial officer, said Tuesday during the company's third quarter earnings conference call.

Cash used for capital expenditures in the third quarter was $350 million. For the full year, the company expects cash used for capital expenditures to total approximately $1.3 billion, he said.

Genentech is currently preparing to resubmit its supplemental Biologics License Application for Avastin with chemotherapy in first-line metastatic breast cancer to the Food and Drug Administration by mid-2007, Dr. Susan Hellman, Genentech's president of product development, said Tuesday.

The company received a complete response letter regarding its initial sBLA in September. In the letter, the FDA requested a safety and efficacy update from the company's E2100 trial.

Genentech is scheduling meetings with the FDA regarding future cooperative group studies to ensure an agreement regarding the study protocol, Hellman said.

"We believe in the long run, these meetings will optimize our ability to partner with one or two groups to meet the evolving standards of the FDA," she said.

During the quarter, Genentech completed enrollment of a phase 3 study of Avastin in adjuvant colon cancer, she said.

In addition, the company announced that its phase 2 study of Rituxan for patients with relapsing remitting multiple sclerosis met its primary endpoint of reducing Gadolinium-enhancing lesions and showed a statistically significant reduction in the number of relapses among patients treated with Rituxan.

"These results have been extremely encouraging as we move forward with our plan to expand our immunology franchise and further investigate the role of B-cell therapies as treatment for the mass number of patients who struggle with autoimmune diseases," Hellman said.

The company plans to make a "go/no-go" decision on its B-cell program for relapsing remitting multiple sclerosis in the fourth quarter.

Genentech is a biotechnology company located in South San Francisco, Calif.


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