amgen inc (AMGN) Key Developments
BIND Therapeutics, Inc. Announces Completion of Collaboration Agreement with Amgen
Jul 2 14
BIND Therapeutics, Inc. announced the completion of its collaborative research program with Amgen Inc. originally entered into in January 2013. Amgen and BIND have notified each other that they will not be exercising their options to develop an Accurin incorporating the Amgen therapeutic payload. BIND entered into the 12 month collaboration agreement with Amgen in January 2013, with the goal of developing a nanomedicine for treating solid cancer tumors based on BIND's platform for targeted and programmable nanomedicines and Amgen's undisclosed proprietary cancer compound. Under the agreement, Amgen had an option to select a novel Accurin candidate for further development, and if Amgen failed to exercise its option, then BIND had the right to exercise an exclusive option to obtain a license from Amgen to develop, manufacture and commercialize Accurins containing the Amgen therapeutic payload. In December 2013, the option period was extended by six months to July 2014 to allow for completion of the research plan.
Amgen Receives FDA Breakthrough Therapy Designation for Investigational Bite(R) Antibody Blinatumomab in Acute Lymphoblastic Leukemia
Jul 1 14
Amgen announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational bispecific T cell engager (BiTE(R)) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. The Breakthrough Therapy Designation was based on the results of a Phase 2 trial of 189 adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab. Data from the Phase 2 trial were most recently presented at the 50(th) Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 19(th) Congress of the European Hematology Association (EHA). The FDA states that Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A Breakthrough Therapy Designation conveys all of the fast-track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.
Amgen and National Cancer Institute Announce Collaboration for Lung Cancer Trial Program
Jun 24 14
Amgen Inc. announced that it will collaborate with the National Cancer Institute, or NCI, a part of the National Institutes of Health, and other public and private sector partners on the Lung Master Protocol, or Lung-MAP, a new clinical trial program that will use biomarker-driven research and genomic profiling to match squamous cell lung cancer patients to investigational treatments based on their individual cancer profiles. Lung-MAP is the first trial of its kind to study a large number of rare lung cancer subsets under one trial protocol. Lung-MAP is a biomarker-driven, multi-drug, multi-arm Phase II/III registration clinical trial for patients with squamous cell lung cancer. The trial will evaluate five investigational compounds intended to treat squamous cell lung cancer and use genomic sequencing to assign enrolled patients to the treatment arms most likely to provide benefit. Patients will then be randomized into one of five sub-studies where they will receive either standard of care (docetaxel or erlotinib) or biomarker driven targeted therapy with an investigational agent. Each of these sub-studies will be independently powered for overall survival (OS) with an interim analysis for progression-free survival (PFS) to determine whether to proceed from Phase II into Phase III. Lung-MAP is being conducted in collaboration with the NCI, part of the National Institutes of Health, SWOG Cancer Research, Friends of Cancer Research (Friends), the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and MedImmune, AstraZeneca's global biologics R&D arm), and Foundation Medicine.
Amgen Inc. Presents at BIO International Convention, Jun-24-2014 03:15 PM
Jun 17 14
Amgen Inc. Presents at BIO International Convention, Jun-24-2014 03:15 PM. Venue: San Diego Convention Center, San Diego, California, United States.
Shire Is In Spotlight Today
Jun 17 14
Shire plc (LSE:SHP) is into spotlight today for a international takeover. An insider said that Shire was anticipating at least one acquisition approach in 2014. Bristol-Myers Squibb Company (NYSE:BMY), Biogen Idec Inc. (NasdaqGS:BIIB), Amgen Inc. (NasdaqGS:AMGN), Abbvie Inc. (NYSE:ABBV) and Gilead Sciences Inc. (NasdaqGS:GILD) could be the potential buyers.