|Affymax and Takeda Announce Termination of Omontys®; Merck Launches Global Patient Registry Supporting Research in Type 2 Diabetes|
|By Staff and Wire Reports|
|Friday, 13 June 2014 19:46|
Affymax, Inc. and Takeda Pharmaceutical Company Limited (Takeda) Osaka, Japan (June 16, 2014) announced today that their Omontys® (peginesatide) product collaboration and license agreement will terminate effective September 10, 2014.
In February 2013, Affymax and Takeda voluntarily recalled all lots of Omontys and suspended promotional activities in the U.S. following postmarketing reports of serious hypersensitivity reactions including anaphylaxis, which may be life-threatening or fatal.
Takeda has conducted a detailed investigation of these reactions. The investigation has confirmed no quality or manufacturing issues were present but has not identified a specific root cause for the reactions that were observed.
Based on these findings and related discussions with Takeda, Affymax has elected not to exercise its rights with respect to the Omontys New Drug Application (NDA). Takeda will work with the U.S. Food and Drug Administration to withdraw the Omontys NDA.
The Board of Directors of Affymax is reviewing its strategic options as a result of the termination of the collaboration with Takeda.
This termination does not change the outlook for Takeda's consolidated results for fiscal 2014.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the launch of a global registry to evaluate the experiences and outcomes of approximately 20,000 patients with type 2 diabetes in real-world settings over three years. The registry is part of Merck’s new global research initiative evaluating outcomes of patients with type 2 diabetes in everyday clinical practice. The research initiative and the new registry reflect Merck’s broader commitment to generate real-world evidence to help advance diabetes care.
The type 2 diabetes registry will be conducted at more than 900 sites across the United States, Germany, France and Japan. Led by external experts in each country, the registry will evaluate blood glucose control, healthcare resource utilization, medication adherence, quality of life and patient satisfaction.
“Type 2 diabetes is a progressive disease that affects an estimated 382 million people worldwide1,” said Lawrence Blonde, M.D., chair of the Merck type 2 diabetes registry, and director of the Ochsner Diabetes Clinical Research Unit in the Department of Endocrinology, Diabetes and Metabolic Diseases at the Ochsner Medical Center in New Orleans. “By evaluating a full range of data, the Merck registry will provide valuable insights into opportunities to improve the care of people with type 2 diabetes on both regional and global levels.”
“Real-world research is a meaningful assessment of the day-to-day management of patients with diabetes—and is an important complement to clinical trials as we seek to identify unmet needs and new solutions to help improve patient outcomes, access and adherence,” Peter Stein, M.D., vice president, diabetes and endocrinology, Merck Research Laboratories. “We are thrilled to partner with our academic collaborators on this initiative, and to build on Merck’s leadership in diabetes and our commitment to scientific innovation.”
Cellectar Biosciences, Inc. (OTCQX:CLRB), announced a 1-for-20 reverse stock split of its common stock, effective at the close of business today, as a first step in a planned listing of its common stock on the NASDAQ Capital Market.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today the pricing of an underwritten public offering of 7,530,000 Units, consisting of an aggregate of 7,530,000 shares of the Company's common stock and warrants to purchase 2,259,000 shares of the Company's common stock, at a price of $1.50 per Unit.
The Cooper Companies, Inc. (NYSE:COO) will present at the 2014 Wells Fargo Healthcare Conference in Boston, Mass., on June 17, 2014.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO) a robotic exoskeleton pioneer, today announced that CEO Nathan Harding will be interviewed live today by host Maria Bartiromo on Fox Business Network's Opening Bell with Maria Bartiromo.
The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, hospice care, assisted living and urgent care companies, announced today that it will participate in the 2014 Wells Fargo Healthcare Conference on June 18, 2014, in Boston, Massachusetts.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, will participate in a fireside chat at the 9th Annual JMP Securities Healthcare Conference on Tuesday, June 24, 2014, at 9:30 A.M. Eastern Time in New York, NY.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 38 new employees.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, is issuing this press release to clarify for shareholders that NeoStem is not engaged in a new financing.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announced today that its Sherbrooke, Quebec, Canada production facility has received all required operating permits and production will now resume.
OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), today announced that the company has voluntarily halted patient enrollment and dosing in its ongoing Phase 1 clinical trials of its two Wnt pathway inhibitor programs, vantictumab (anti-Fzd7, OMP-18R5) and Fzd8-Fc (OMP-54F28).
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today, that David Aviezer, Ph.D., has decided to retire after almost 12 years from his role as the Company's President and Chief Executive Officer.
Symmetry Medical Inc. (NYSE:SMA), a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that Thomas Sullivan, President and Chief Executive Officer, and Fred Hite, Senior Vice President and Chief Financial Officer are scheduled to present at the Wells Fargo 2014 Healthcare Conference in Boston.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) announced that all of the nominees listed in the management information circular for the annual meeting of shareholders held on Wednesday, June 11, 2014 were elected as directors of the Company.
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that it will host a conference call and live audio webcast on Monday, June 16, 2014 at 08:00 a.m. Eastern Time with Dr. Marc Pellegrini, Laboratory Head, Infection and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia.
TG Therapeutics, Inc. (Nasdaq:TGTX), an innovative, clinical-stage biopharmaceutical company today announced preliminary clinical results from its ongoing Phase 2 study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib (IMBRUVICA™), the oral BTK inhibitor from Pharmacyclics/Janssen.