Herceptin Drug

Genentech Inc. said it will charge $575 per dose for Herceptin, its newly approved drug for treating breast cancer that has metastasized. Wholesalers, which sell the drug to pharmacies or hospitals, will charge an average of about $718 per dose, the company said. The cost to the patient for the treatment, which is administered weekly, will vary depending on further markups and individuals' insurance policies.

Herceptin, a drug that increases survival in certain breast cancer patients, won the endorsement Wednesday of a Food and Drug Administration advisory panel--a crucial step before it can be marketed in the U.S. The genetically engineered medication, produced by Genentech Inc. of South San Francisco, is among the first of a new breed of pharmaceuticals that make use of genetic differences between normal and cancer cells. And it is the first directed against a major form of cancer.

Tamoxifen, the first drug touted as a powerful preventive against breast cancer, won a reluctant nod Wednesday from government scientists advising the Food and Drug Administration. But in recommending that the federal agency approve tamoxifen's use for preventing breast cancer in high-risk women, an FDA advisory panel expressed concern that the drug may do less--and for fewer women--than originally hoped.

The Food and Drug Administration gave final approval Friday to Herceptin, a drug developed by Genentech Inc. to target an especially aggressive form of breast cancer. Based on discoveries by UCLA scientists, the drug is being hailed as one of the first of a new class of therapies that will supplement surgery, chemotherapy and radiation in the treatment of malignancies.

Supplies of the new breast cancer drug, Herceptin, began arriving at clinics and doctors' offices this month, ushering in a new era of cancer treatment that attempts to target the very flawed genetic mechanisms that cause the disease. Herceptin is undoubtedly a major advance. But it has limits. The drug is for women with breast cancer that has spread to other parts of their bodies, or metastasized, a condition that typically yields very low survival rates.

Genentech Inc. said a charged-up version of its Herceptin drug for breast cancer shrank tumors in patients who failed to respond to other therapies. Four out of 10 patients had their tumors shrink during a study, with minimal side effects, when taking a version of Herceptin linked to chemical toxins, researchers said at the American Society of Clinical Oncology meeting in Chicago. The combination is in the first of three phases generally needed for U.S. marketing approval.

The Food and Drug Administration agreed to expand the use of Genentech Inc.'s breast cancer drug Herceptin to include some women with early-stage cancer who have undergone surgery, the company said Thursday. Herceptin is used to treat the 25% to 30% of breast cancer patients who have tumors that generate a protein called HER-2. Those tumors tend to grow faster and are more likely to recur than tumors that do not carry the protein.

Genentech Inc. said Monday that its drug Herceptin prolonged the lives of breast cancer patients in two large clinical trials, setting the stage for a new way to treat the disease. The drug, which is used to treat advanced breast cancer, also showed effectiveness in preventing recurrence of the disease in patients who had undergone surgery for early breast cancer.

Genentech Inc.'s breast cancer drug Herceptin, which had sales of $346.6 million last year, infringes a patent held by Chiron Corp., a federal judge in Sacramento has ruled. The Monday ruling sends the case to a trial in August. A jury will decide whether the Chiron patent is valid and if Genentech willfully infringed it, which would result in triple damages.. Emeryville, Calif.

Two of the nation's largest biotechnology companies, Genentech Inc. and Chiron Corp., are locked in a dispute over rights to one of Genentech's most successful products, the breast cancer drug Herceptin. Chiron is suing Genentech in federal court, claiming it holds a critical patent on the technology behind Herceptin. The stakes are huge. Chiron is asking for as much as 30% of Herceptin sales until its patent expires in 2005. That could total more than $300 million. The trial, which began Aug.