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 ...
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Genentech Gains Access to Peptidream's Discovery Technology
Jul 20 16
Peptidream Inc. has granted non-exclusive rights to its peptide discovery platform to Roche's biotechnology subsidiary, Genentech. As part of the agreement, Peptidream will receive an undisclosed upfront payment and annual technology access fees. It is entitled to development milestones and sales royalties for products that will arise from the use of its technology. Peptidream first started its collaboration with Genentech in December 2015. The two companies are identifying peptides and optimise them into therapeutic peptides or small molecule products.
Genentech Provides Update on Phase III Study of Gazyva in People with Previously Untreated Diffuse Large B-Cell Lymphoma
Jul 18 16
Genentech announced that the Phase III GOYA study evaluating Gazyva (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint of significantly reducing the risk of disease worsening or death (progression-free survival; PFS) compared to Rituxan (rituximab) plus CHOP chemotherapy (R-CHOP). Adverse events with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies. Data from the GOYA study will be presented at an upcoming medical meeting. GOYA (NCT01287741) is a global Phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of the combination of Gazyva plus CHOP chemotherapy (G-CHOP) compared to Rituxan plus CHOP chemotherapy (R-CHOP). GOYA included 1,418 previously untreated patients with CD20-positive DLBCL. The primary endpoint of the study is investigator-assessed PFS, with secondary endpoints including PFS assessed by independent review committee (IRC), response rate (overall response, ORR; and complete response, CR), overall survival (OS), disease free survival (DFS) and safety profile. The GOYA study is being conducted in cooperation with the Fondazione Italiana Linfomi (FIL, Italy). Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. As many as 40% of patients will relapse, at which point their prognosis is poor. In the United States, it is estimated that more than 24,000 new cases of DLBCL will be diagnosed in 2016. Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen. Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers. Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that can become serious or life threatening, including: Hepatitis B Virus (HBV); Progressive Multifocal Leukoencephalopathy (PML): The most common side effects of Gazyva in CLL are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea. The safety of Gazyva was evaluated based on 392 patients with indolent NHL (iNHL) of whom 81% had follicular lymphoma. In patients with follicular lymphoma, the most common side effects that were seen were consistent with the overall population who had iNHL. The most common side effects of Gazyva are infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness, and urinary tract infection. The most common side effects of Rituxan are infusion reactions, chills, infections, body aches, tiredness and low white blood cells. Patients must tell their doctor if they are pregnant, plan to become pregnant or are breastfeeding. It is not known if Rituxan may harm the patient’s unborn baby or pass into the patient’s breast milk. Women should use birth control while using Rituxan and for 12 months after treatment.
European Court of Justice Orders Genentech to Pay Licensing-Agreement Royalties to Sanofi
Jul 12 16
On 7 July, the European Court of Justice (ECJ) handed down a ruling ordering Genentech to pay agreed running-royalties to the German unit of Sanofi (France) under a licensing agreement. The case concerned a licensing agreement that required the licensee to pay royalties for the use of a patent that had been revoked. The ECJ ruling is a significant legal judgement, and is likely to mean that in future the beneficiary of a patent licence will be obliged to pay royalties even in the case that the company does not infringe on the patent technology in question. The ECJ interpreted the royalty as being part of the price that is paid for "commercial exploitation of the patented technology with the guarantee that the licensor will not bring legal proceedings for infringement against the licensee". The ECJ has taken the view that there is nothing to "prohibit the obligation to pay a royalty for the use of technology, even where such use does not give rise to an infringement, or the technology is deemed never to have been protected in the event of retroactive revocation of the patent". This could hold legal implications for other pharmaceutical companies, as the court ruling suggests that royalties for unpatented technology is not anticompetitive under European Union (EU) legislation. This is expected to have certain practical legal considerations, and should invite additional caution on the part of pharmaceutical companies when negotiating future licensing agreements in the EU.