Genentech recently announced the following:

Marketed and Pipeline Product Events BioOncology

• Rituxan® (Rituximab): Announced FDA approval of a new label for Rituxan to include retreatment with Rituxan after a prior course of Rituxan therapy, initial treatment doubled from four to eight weekly infusions of Rituxan, and treatment of bulky disease (tumors greater than 10 centimeters) and some significant adverse reactions for patients with low-grade non-Hodgkin's lymphoma (NHL).
• Tarceva™ (OSI-774): With partners Roche and OSI Pharmaceuticals, presented positive results from a Phase II advanced refractory ovarian cancer trial of Tarceva at the 37th annual meeting of the American Society of Clinical Oncology (ASCO) in May. Also presented findings from three Phase II trials of Tarceva demonstrating encouraging anti-cancer activity and Tarceva's potential utility as a single agent for the treatment of patients with refractory non-small cell lung cancer (NSCLC) and head and neck cancer. The companies also initiated Phase II clinical trials in metastatic breast cancer.
• Avastin™ (Bevacizumab): Received fast-track approval status from the FDA for Avastin, or anti-VEGF, in combination with capecitabine (Xeloda®) for the potential treatment of metastatic breast cancer.
• Herceptin® (Trastuzumab): In May at ASCO, presented data from three studies demonstrating that FISH (fluorescence in situ hybridization) testing of tumor tissue for HER2 gene amplification appears to be an effective method for selecting women with HER2 positive metastatic breast cancer who are most likely to respond to Herceptin therapy.
• 2C4: Filed an investigational new drug application for 2C4 for the potential treatment of solid-tumor cancers

Cardiovascular Medicine

• Tracleer™ (Bosentan): With partner Actelion Ltd., announced positive results for oral endothelin receptor antagonist Tracleer in a Phase III pulmonary arterial hypertension (PAH) study. The new data will supplement the United States and European marketing approval applications filed last year.
• Veletri™ (tezosentan): With partner Actelion Ltd., announced the second pivotal Phase III clinical trial of Veletri - an intravenous dual endothelin receptor antagonist - did not meet its primary objective of significantly improving symptoms (dyspnea, or shortness of breath) associated with acute heart failure.
• Cathflo™ Activase® (Alteplase): Reported positive results of a large-scale Phase III study of safety of Cathflo Activase for treatment of occluded central venous catheters. Genentech reported positive results earlier this year of an efficacy study of Cathflo Activase, which is currently awaiting FDA approval.
• TNKase™ (Tenecteplase): With collaborators COR Therapeutics, Inc. and Boehringer Ingelheim, completed enrollment in the ASSENT III study of TNKase in combination with various regimens of anti-thrombotic agents for acute myocardial infarction (heart attack). The companies are on schedule to present findings at the annual meeting of the European Society of Cardiology in September.
• Anti-tissue factor: Moved anti-tissue factor into development for the potential treatment of acute coronary syndrome.

Opportunistic

• Xanelim™ (Efalizumab): With partner XOMA Ltd., presented initial positive results from the first of two pivotal Phase III studies of Xanelim for adults with moderate-to-severe plaque psoriasis at the Second Joint Meeting of the International Psoriasis Symposium and European Congress on Psoriasis held in San Francisco.
• Xolair™ (Omalizumab): With Novartis AG, announced the receipt of a Complete Response letter from the FDA for the license application for Xolair, filed on June 6, 2000. The letter requests additional preclinical and clinical data, as well as pharmacokinetic information. It is anticipated that the initial proposed label claim will likely be for adult allergic asthma. With the requirement of additional data, there will not be an FDA approval of Xolair in 2001. The exact timing of resubmission to the FDA will be dependent on the scope of the discussions with the FDA.
• Growth hormone: Reacquired from Schwarz Pharma the exclusive development and marketing rights for human growth hormone products Nutropin AQ® [somatropin (rDNA origin) injection] and Nutropin Depot® [somatropin (rDNA) for injectable suspension] in Europe and other countries outside the United States, Canada, China, and Japan. Genentech is actively looking for potential new partners for the ex-U.S. development for these products.
• INS365 and INS37217: Returned rights to INS365 Respiratory for chronic bronchitis and INS37217 Respiratory for cystic fibrosis and sinusitis to Inspire Pharmaceuticals, Inc.

Corporate Business Events

• Defeated patent infringement lawsuit brought by GlaxoSmithKline relating to Herceptin and Rituxan and obtained jury verdict that those products do not infringe and that Glaxo's patent claims are invalid.
• Successfully defended Genentech's European patent relating to immunoadhesin therapeutics against challenges filed by Biogen and Genetics institute.
• Named Thomas T. Thomas to Treasurer and David Ebersman to Senior Vice President, Product Operations.