THE ONE

  But not the Only

With the most advanced, efficacious and far-reaching cancer drugs, Avastin, Herceptin, Rituxan, and Tarceva, Genentech (DNA), has become the King of the biotech industry, the most envied by the pharmaceutical industry in general and the most promising of the drug industrial group.  Yesterday, another of its cancer products, Herceptin, emerged as a new power in breast cancer.   Phase 3 trials of the drug were stopped early after a preliminary joint interim analysis demonstrated an improvement in the primary endpoint of disease-free survival and in the secondary endpoint of overall survival. The trials compared Herceptin plus chemotherapy to chemotherapy alone as adjuvant therapy following initial treatment with surgery for women with early-stage (or cancer that has not spread beyond the breast and associated lymph nodes) human epidermal growth factor receptor 2 (HER2) positive breast cancer.

The two studies were sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG), who conducted this prospectively-designed joint interim analysis following consultation with the FDA. Results from these studies will be presented at the American Society of Clinical Oncology (ASCO) annual meeting, May 13 - 17, 2005.

What the data suggest?

They suggest for the first time that a therapy that targets women whose tumors have a specific genetic mutation has the potential to reduce the recurrence of disease in early-stage breast cancer patients and that adjuvant therapy with Herceptin plus chemotherapy for women with early-stage HER2- positive breast cancer may increase the chance of long-term survival.

The interim analysis was based on information from 3,300 patients. These studies will stop enrolling new patients and the cooperative groups will continue to monitor patients for longer-term data. Each of the studies was a randomized, controlled trial that evaluated the combination of anthracycline and cyclophosphamide (AC) followed by paclitaxel, with or without Herceptin using different treatment schedules of paclitaxel in women with HER2-positive breast cancer.

Based on the positive results from four recent Phase 3 trial analyses in the past five weeks, three of which occurred earlier than anticipated, Genentech will continue to evaluate its expected short- and long-term product demand and to assess its manufacturing plans and capacity to meet expected demand. The company expects to provide further information on manufacturing at the time of Q2 earnings results.

About the Herceptin Adjuvant Clinical Trial Program

Based on positive data observed when adding Herceptin to chemotherapy in patients with HER2-positive metastatic breast cancer, several cooperative groups are investigating Herceptin in combination with chemotherapy as a potential treatment in early-stage breast cancer. In addition to the NSABP and NCCTG adjuvant studies, two additional international adjuvant trials are underway, evaluating Herceptin with several different chemotherapy regimens, and in total will enroll more than 13,000 women with early-stage, HER2- positive breast cancer. Each study was designed with interim analyses.

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.

Herceptin received FDA approval in September 1998 for use in women with metastatic breast cancer who have tumors 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, in Japan by Chugai, and internationally by Roche.

In clinical trials, Herceptin has shown a survival benefit when used in combination with chemotherapy. 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).

Herceptin Safety Profile: Visit the company’s Website or read the press release.

Is it something?

Genentech has become the #1 biotech company in terms of revenues and market cap. It has become the perfect model for a perfect drug company. It is on the top now and will continue to be. But, believe you me, the top can accommodate many biotechs and we assure you that many of the firms that we consider having strong scientific and managerial fundamentals are on their way to join Genentech.

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