Genentech Avastin Supply Will Come From Two Sites; BLA Coming Soon
Executive Summary
Commercial supply for Genentech's vascular endothelial growth factor inhibitor Avastin could come from two manufacturing facilities, Chief Medical Officer Susan Hellmann, MD, said during an investor conference call July 9
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Commercial supply for Genentech's vascular endothelial growth factor inhibitor Avastin could come from two manufacturing facilities, Chief Medical Officer Susan Hellmann, MD, said during an investor conference call July 9. "It would be our preference" to have both the South San Francisco and Vacaville, Calif. manufacturing facilities approved by FDA in time for Avastin's launch, Hellmann said. "A lot of that will depend on whether it's a January, February [or] March timing" for Avastin (bevacizumab) approval. Genentech will meet with FDA regarding Avastin's manufacturing facilities before the end of July. The South San Francisco facility is awaiting a pre-approval inspection, and Genentech will soon submit an application for the Vacaville facility. "We will have an additional meeting with the FDA to clarify the BLA strategy for manufacturing later this month. We anticipate that this aspect of the filing will fit within the same timeline," Hellmann said. Genentech expects to file an Avastin BLA for colorectal cancer treatment before the end of the third quarter. "We believe our Phase III colorectal cancer study will be sufficient to file the BLA....Our goal for filing the complete BLA is the end of September," Hellmann said. The company made the determination following a pre-BLA meeting with FDA. The launch timing indicates that Genentech expects to receive approval for Avastin within the first FDA review cycle, or possibly before the six-month deadline. Genentech received a "fast-track" designation for the BLA and will seek a priority review. Avastin's impressive Phase III results in colorectal cancer caught the medical and investor communities by surprise: patients receiving Avastin plus standard-of-care chemotherapy had a 50% increase in their chance for survival compared with chemotherapy alone (1 (Also see "Avastin To Be Standard Add-On Agent In Colorectal Cancer, Genentech Says" - Pink Sheet, 9 Jun, 2003.), p. 26). In announcing the Phase III results during the American Society of Clinical Oncology annual meeting, Genentech predicted that Avastin would become the standard add-on therapy to chemotherapy for use in first-line metastatic colorectal cancer. With the potential for multiple facilities manufacturing its products, Genentech is hoping to alleviate concerns about meeting customer demand. The South San Francisco facility has a capacity of 100,000 liters, with Vacaville adding another 140,000 liters. "I know there have been many questions relating to our manufacturing capacity for antibody production following the positive news around Avastin and Xolair ," Hellmann acknowledged. However, "Genentech has sufficient capacity either online or under construction to meet our current forecasted product demand." "Should we determine that additional capacity is needed, then we would consider various options for manufacturing during the 2005 through 2008 timeframe," she assured investors. Genentech started shipping Xolair (omalizumab) the week of July 7; sales reps will begin promoting the biologic to allergists and pulmonologists the week of July 21. The allergic asthma treatment cleared FDA June 20 (2 (Also see "Genentech Xolair Average Cost Is $10,000 A Year; Mid-July Launch Planned" - Pink Sheet, 23 Jun, 2003.), p. 26). Novartis and Genentech will co-market Xolair with each company providing 125 sales reps. The approval of Xolair, which had been delayed by additional data requirements from FDA, will not hold back other Genentech launches, the company said. "The commercial organization is prepared to potentially launch multiple products from our pipeline over the next 18 months and...we deliberately structured our business units so that if we were permitted with such an opportunity, the workload would be spread throughout the organization," Chief Operating Officer Myrtle Potter said. Avastin and Genentech's psoriasis biologic Raptiva will be detailed by separate sales forces, she noted. The BLA for Raptiva (efalizumab, formerly Xanelim ) was submitted in late 2002. A safety supplement was recently filed with FDA; the Raptiva BLA now contains approximately 2,700 patients. "We continue to expect FDA action in late 2003 and anticipate as with most biologics that we will have an advisory panel some time in Q3 2003," Hellmann said. FDA's Arthritis Advisory Committee is scheduled to meet Sept. 29-30. |