avastin application in the EU, herceptin appeal in UK--Wall St. Journal

[Lani]

Roche Seeks Wider Usage
Of Cancer Drug in Europe
A WALL STREET JOURNAL NEWS ROUNDUP
July 11, 2006
Swiss drug maker Roche Holding AG said it filed its Avastin drug for use in previously untreated advanced breast cancer in Europe, following positive late-stage trial data.

A Phase III study had shown the addition of Avastin to standard chemotherapy as a primary treatment for advanced breast cancer doubled the time women lived without their disease advancing, compared with chemotherapy alone, Roche said.

The drug, which works by starving tumors of blood supply, had already been filed to treat breast cancer in the U.S. in May. Avastin was initially approved for use in advanced colorectal cancer in early 2005 in Europe and in 2004 in the U.S., and it has also been filed for fighting lung cancer in the U.S.

Roche expects to file the drug for use in nonsmall-cell lung cancer, the most common form of the disease, later this year. It has also been filed in Japan for use in colorectal cancer.

Avastin is one of the top sellers for Roche and is produced by majority-owned U.S. biotech company Genentech Inc., which is looking to widen the potential blockbuster in 25 cancer types including pancreatic, ovarian and prostate, and renal-cell carcinoma.

Industry analysts said the latest filing had been expected but was still positive for Roche.

Separately, the U.K.'s medical cost-effectiveness watchdog yesterday said it received an appeal against its plan to make Roche's breast-cancer drug Herceptin available through the National Health Service for women in the early stages of the disease.

In June the National Institute for Health and Clinical Excellence, which examines treatments for value for money, said it was proposing to make the drug available in England and Wales for treating women with early-stage HER2-positive type of breast cancer. The agency declined to comment further on the appeal.