Company Overview of Genentech, Inc.
Genentech, Inc., a biotechnology company, engages in the research, development, manufacture, and marketing of biotechnology products for treating patients with serious or life-threatening diseases in the United States. It offers molecular entities and medicines in the areas of oncology, immunology, neuroscience, metabolism, and infectious diseases. The company also offers hematology medicines that include antibody-drug conjugates, small molecule antagonists, and small molecule BCL-2 inhibitors. Genentech, Inc. has a strategic alliance with Array biopharma; clinical trial collaborations with Clovis Oncology and Astex Pharmaceuticals, Inc.; and an immunotherapy trial collaboration with Immune ...
1 DNA Way Mailstop 258A
South San Francisco, CA 94080-4990
Founded in 1976
Key Executives for Genentech, Inc.
Co-Founder and Member of Scientific Resource Board
Senior Vice President and General Counsel
Chief Compliance Officer, Head of Legal Affairs for North America, Senior Vice President and Secretary
Vice President of Human Resources and Regional Human Resources Head of North America
Senior Vice President of Specialty Biotherapeutics & Managed Care and General Manager of Specialty Biotherapeutics & Managed Care
Compensation as of Fiscal Year 2016.
Genentech, Inc. Key Developments
FDA Grants Genentech’s Cancer Immunotherapy TECENTRIQ® (Atezolizumab) Priority Review in Additional Type of Advanced Bladder Cancer
Jan 9 17
Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. This sBLA submission for TECENTRIQ is based on results from the Phase II IMvigor210 study, and the FDA will make a decision on approval by April 30, 2017. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. TECENTRIQ is currently approved by the FDA to treat people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy or whose disease has worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy. TECENTRIQ is approved under accelerated approval for this indication based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. TECENTRIQ is also approved for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
Genentech Receives Approval from U.S. Food and Drug Administration of Lucentis for Myopic Choroidal Neovascularization
Jan 5 17
Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Lucentis (ranibizumab injection) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT). At three months, average visual acuity gains for patients treated with Lucentis were more than 12 letters, compared to 1.4 letters for those treated with vPDT. Pathological myopia causes the eye to grow too long from front to back, resulting in nearsightedness. In mCNV, new, abnormal blood vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina, which can cause irreversible central vision loss. Symptoms of mCNV include spots of central blurred or distorted vision, a sudden worsening of central vision or difficulty distinguishing colors.
Genentech Emicizumab for Hemophilia A Meets Primary Endpoint in Phase III Study
Dec 22 16
Genentech announced that the primary endpoint has been met for the Phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or older with hemophilia A and inhibitors to factor VIII. The study showed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. The study also met all secondary endpoints, including a statistically significant reduction in the number of bleeds over time with emicizumab prophylaxis treatment in an intra-patient comparison in people who had received prior bypassing agent prophylaxis treatment. The most common adverse events with emicizumab were injection site reactions, consistent with prior studies. As previously reported, two patients had thromboembolic events and two patients developed thrombotic microangiopathy (TMA). The common aspect between all cases of thromboembolic events and TMA is that they occurred in patients who were on emicizumab prophylaxis and in addition received activated prothrombin complex concentrate to treat breakthrough bleeds. Neither thromboembolic event required anti-coagulation therapy and one patient restarted emicizumab. Both cases of TMA have completely resolved, and one patient restarted emicizumab.
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