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Highlighted below are major events that occurred in 2000 and early 2001.
Oncology
- With partners Roche and IDEC Pharmaceuticals Corporation, announced positive interim results from a Phase III study of Rituximab (Rituxan/ MabThera) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy in previously untreated patients with aggressive non-Hodgkin's lymphoma.
- In conjunction with F. Hoffmann-La Roche and leading cancer cooperative groups, initiated large randomized Phase III clinical trials to evaluate Herceptin in the adjuvant setting for early-stage breast cancer.
- Announced at the American Society of Clinical Oncology (ASCO) annual meeting, positive results from a Phase II study investigating Herceptin as a single agent for patients with previously untreated HER2-positive metastatic breast cancer.
- Announced, also at ASCO, preliminary positive results from Phase II trials evaluating anti-VEGF in combination with chemotherapy in patients with advanced metastatic colorectal and non-small cell lung cancers, as well as positive interim Phase II results of trials evaluating anti-VEGF as a single agent in patients with relapsed metastatic breast cancer.
- Initiated Phase III clinical trials of anti-VEGF in colorectal and breast cancers.
- Moved 2C4, a monoclonal antibody, into development for the potential treatment of a variety of solid-tumor cancers.
- With OSI Pharmaceuticals, Inc. and Roche, announced agreements for the global codevelopment and commercialization of OSI's lead anti-cancer drug, OSI-774.
Cardiovascular Medicine
- Received U.S. Food and Drug Administration (FDA) approval of and launched TNKase (Tenecteplase), the first five-second, single-dose thrombolytic for the treatment of acute myocardial infarction (AMI), or heart attack.
- Submitted to the FDA and had accepted for review a supplemental Biologics License Application (sBLA) for Activase for use in catheter clearance.
- Initiated Phase III clinical trials in collaboration with other major pharmaceutical manufacturers to test TNKase in combination with various leading anti-thrombotic agents in the treatment of AMI.
- Signed a licensing agreement with Actelion Ltd. for the development and copromotion in the United States of tezosentan, which is in Phase III trials for the potential treatment of acute heart failure.
- Signed a second licensing agreement with Actelion for the development and copromotion in the United States of Tracleer, also in Phase III trials, for the potential treatment of pulmonary hypertension and acute and chronic heart failure.
- Announced results indicating that the Phase II clinical trial of anti-CD18 for the treatment of heart attack did not meet its primary objectives.
- Announced a collaborative agreement with COR Therapeutics, Inc. and Schering-Plough Corporation to copromote INTEGRILIN for non-ST-segment acute coronary syndrome, and TNKase and Activase for acute ST-segment-elevation AMI.
Opportunistic
- With partners Novartis Pharmaceuticals Corporation and Tanox, Inc., filed a Biologics License Application (BLA) with the FDA for Xolair for the potential treatment of asthma and seasonal allergic rhinitis.
- Completed patient enrollment in two pivotal Phase III clinical trials evaluating Xanelim anti-CD11a antibody in patients with moderate to severe psoriasis, and completed enrollment in a Phase I/II clinical study of Xanelim in the prevention of kidney transplant rejection. Genentech is developing Xanelim with XOMA Ltd.
- Launched Nutropin Depot, the first long-acting dosage form of recombinant growth hormone, indicated for the treatment of growth failure due to inadequate endogenous growth hormone secretion in children, and developed with partner Alkermes, Inc.
- Completed a Phase III clinical trial of Pulmozyme in early-stage cystic fibrosis and presented positive results at the North American Cystic Fibrosis Conference.
- With Alkermes, Inc., announced a decision to proceed with a Phase II/III clinical trial of Nutropin Depot in growth-hormone-deficient adults.
- In collaboration with Genentech, Millennium Pharmaceuticals, Inc. initiated Phase II clinical trials of LDP-02 for inflammatory bowel disease.
- In collaboration with Genentech, Inspire Pharmaceuticals, Inc. initiated Phase II clinical trials of INS365 for patients with chronic bronchitis, and filed a new drug application for INS37217 Respiratory for the treatment of cystic fibrosis.
- Was named in 2001 for the third consecutive year to Fortune magazine's annual list of "100 Best Companies to Work for in America."
- Appointed Myrtle S. Potter as executive vice president, commercial operations, and chief operating officer.
- Named as senior vice presidents: Richard H. Scheller, Ph.D., research; Robert L. Garnick, Ph.D., regulatory, quality and compliance; and Kimberly J. Popovits, marketing and sales.
- Named as vice presidents: Claudia Estrin, decision support and commercial innovation; Roy Hardiman, corporate law, and assistant secretary; R. Guy Kraines, finance; Joseph S. McCracken, business and commercial development; David Nagler, human resources; Andrew Scherer, engineering, facilities, strategic planning and support; and John M. Whiting, controller and chief accounting officer.
- Received multiproduct FDA licensure for the new, state-of-the-art manufacturing facility in Vacaville, Calif. Also, purchased a cell culture manufacturing facility in Porriño, Spain, that will supplement Genentech's existing bulk cell culture production capacity.
- Roche completed the public offering of 34.6 million Genentech shares.*
- In October, announced a two-for-one stock split that was effective October 24, 2000 in the form of a stock dividend.