|Amgen Says Aranesp RED-HF Trial Did Not Meet Primary Endpoint; FDA Will Not Meet PDUFA Date for Hyperion's Ravicti|
|By Staff and Wire Reports|
|Wednesday, 16 January 2013 20:22|
Amgen (NASDAQ: AMGN) announced top-line results of the Phase 3 Aranesp® (darbepoetin alfa) RED-HF® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial. The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo. The study did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (Hazard Ratio 1.01, 95 percent CI 0.90, 1.13).
"The RED-HF Trial was designed and powered to evaluate whether the treatment of anemia could improve morbidity and mortality in systolic heart failure patients," said Michael Severino, M.D., senior vice president of Global Development and corporate chief medical officer at Amgen. "While the study did not meet its key endpoints, we thank the patients and investigators who participated in RED-HF and helped answer this important question."
There were no new safety findings identified in the study. The most frequently reported adverse events in the study were cardiac failure, dyspnea, diarrhea, congestive heart failure and dizziness.
These summary results will be followed by full efficacy and safety analyses, which will be shared and discussed with global regulatory agencies and submitted for presentation at an upcoming medical meeting.
Aranesp is indicated for the treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Aranesp has not been shown to improve quality of life, fatigue or patient well-being.
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with protein misfolding and apoptosis centered around its patented therapeutic protein Mesencephalic Astrocyte-derived Neurotrophic Factor (MANF), today announced that an independent peer-reviewed research paper entitled Mesencephalic astrocyte-derived neurotrophic factor (MANF) secretion and cell surface binding are modulated by KDEL receptors was published in the Journal of Biological Chemistry.
Hyperion Therapeutics, Inc. (Nasdaq: HPTX) said the U.S. FDA has advised the Company not to expect a final action by the Prescription Drug User Fee Act (PDUFA) action date of January 23, 2013.
The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion's New Drug Application (NDA) for Ravicti™ (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders (UCD).
Abattis Bioceuticals Corp. (OTC PINK: ATTBF) (CNSX: FLU), announces it has been granted Intl Class 5 Trademark for DefenZall™ in Taiwan and the USA.
ActiveCare, Inc. (OTCBB: ACAR) ("ActiveCare" or the "Company") announced today that it has engaged Ansley Securities LLC ("Ansley") to provide strategic advisory services and act as its exclusive financial advisor for a capital raise to support the organic growth of its operations. Ansley has been at the forefront of helping to build innovative companies with disruptive technologies in the healthcare industry with over $500 million in capital raises and mergers and acquisitions over the past several years.
Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 Aranesp® (darbepoetin alfa) RED-HF® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial.
Converge Global, Inc (PINKSHEETS: CVRG) is a United States based company with plans to develop and operate a unique online portal and media platform to service the hospitality and food service industries, locally, domestically and internationally.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that Robert (Bob) Cathcart has joined the Company in the newly created position of Senior Vice President, Global Sales.
InterMune, Inc. (Nasdaq: ITMN) today announced that it has agreed to sell an aggregate of $105,000,000 principal amount of its 2.50% convertible senior notes due 2017 and 13,500,000 shares of its common stock at a price to the public of $9.90 per share in concurrent underwritten public offerings.
Level 3 Communications, Inc. (NYSE: LVLT) today announced that Courtagen Life Sciences Inc., a global life sciences company and clinically certified genetic testing lab, is using Level 3's secure, efficient network solutions to directly download and transmit massive amounts of data to generate clinically actionable results for patients.
Luminex Corporation (Nasdaq: LMNX) today announced that it expects to report results for the fourth quarter of 2012 on Monday, February 4, 2013.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced the pricing of an underwritten public offering of 4,400,000 shares of its common stock.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy, specialty infusion and hospital pharmacy management services, today announced that Michael J. Culotta, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the Noble Financial Capital Markets Ninth Annual Equity Conference in Hollywood, FL, on Wednesday, January 23, 2013, at 11:30 a.m. Eastern Standard Time.