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www.fdanews.com/articles/81770-genentech-s-third-quarter-earnings-boosted-by-cancer-drug-sales

GENENTECH'S THIRD-QUARTER EARNINGS BOOSTED BY CANCER DRUG SALES

October 19, 2005

Rising demand for Genentech's two main cancer drugs — Avastin and Herceptin — drove up the biotech firm's third-quarter earnings by more than 50 percent.

Sales of the firm's flagship product Avastin (bevacizumab) jumped 78 percent during the quarter, increasing to $325.2 million from $183.0 million in the same period of 2004. Although Avastin, which starves tumors by preventing the growth of new blood vessels, is currently approved only to treat colon cancer, Genentech said off-label demand for the drug is growing. Roughly 15 percent of Avastin's third-quarter sales was attributed to uses outside of colon cancer, the company said recently.

Avastin's market is likely to expand even further in the future, as Genentech is working to expand the drug's indications. Recent trials have suggested Avastin is effective against both lung and breast tumors, and Genentech said it plans to file supplemental biologics license applications (sBLAs) with the FDA for those uses during the first half of 2006. The company is also studying Avastin as a potential treatment for metatastic ovarian cancer and rheumatoid arthritis.

Genentech also received a boost during the third quarter from its older cancer drug, Herceptin (trastuzumab), which saw its sales rise 70 percent to $215.1 million from $126.3 million in last year's third quarter. Herceptin was boosted by data from a large-scale clinical study that showed the drug can reduce the risk of postsurgical cancer recurrence by approximately 50 percent. Genentech is also looking to expand Herceptin's indication. The firm said it anticipates filing a sBLA in the first quarter of 2006 for Herceptin in the adjuvant setting based on data from U.S. studies.