Genentech Inc and Wyeth Pharmaceuticals, a division of Wyeth have entered into a manufacturing agreement for Herceptin (Trastuzumab).
Under this agreement, Wyeth Pharmaceuticals will manufacture Herceptin bulk drug substance for Genentech at Wyeth's production facility in Andover, Massachusetts. Financial terms of the agreement have not been disclosed.
Herceptin is a targeted therapeutic antibody treatment for women with HER2-positive metastatic breast cancer, an especially aggressive form of the disease that affects approximately one-fourth of women with breast cancer. Special testing is required to identify women who are HER2-positive and candidates for treatment with Herceptin.
"Wyeth has a strong track record as a manufacturer of biopharmaceuticals, and we are very pleased to enter into this agreement for the production of Herceptin, which will assist us in our mission of delivering life-saving therapies to patients," said David A. Ebersman, senior vice president, Product Operations, Genentech. "The additional capacity provided by this agreement will help us manufacture product in response to increases in demand for our therapeutic antibody products."
In clinical trials, Herceptin has shown an important survival benefit when used in combination with doxorubicin or epirubicin plus cyclophosphamide, or paclitaxel. In December 2001, Genentech received FDA approval to include data that showed a 24 percent increase in median overall survival for women with HER2-positive metastatic breast cancer treated initially with Herceptin and chemotherapy compared to chemotherapy alone (median 25.1 months compared to 20.3 months).
"This agreement provides Wyeth with an important opportunity to continue to build our biopharmaceutical business by working with Genentech, which is one of the industry's leaders in biotechnology and oncology innovation," said Cavan Redmond, executive vice president and General Manager, Wyeth BioPharma. "We are looking forward to using our biotechnology expertise and experience to manufacture this key oncology product in our Andover facility."
Herceptin received US FDA approval in September 1998 for use in women with metastatic breast cancer who have tumours that overexpress the HER2 protein. It is indicated for weekly treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy. Herceptin is marketed in the United States by Genentech and internationally by Roche.