|Affymax Wins U.S. Panel’s Backing on Anemia Drug; A Statement on Teva's Plan B One-Step by Secretary Sebelius|
|By Staff and Wire Reports|
|Wednesday, 07 December 2011 20:16|
Affymax Inc. (NASDAQ:AFFY) won a U.S. panel’s backing for an experimental anemia medicine that would compete with treatments marketed by Amgen Inc. (NASDAQ:AMGN) and Johnson & Johnson (NYSE:JNJ) for patients with chronic kidney disease.
The benefits of the drug, known as peginesatide, outweigh potential heart risks, outside advisers to the Food and Drug Administration said today in a 15-1 vote in Silver Spring, Maryland. The FDA isn’t required to follow the advisory panels’ recommendations.
“As a result of this vote, we expect Affymax shares to be up sharply tomorrow -- likely into the double-digits,” Christopher Raymond, an analyst at Robert W. Baird in Chicago, said today in a note to investors. Trading on Affymax was halted pending the outcome of the meeting. The shares had declined 19 percent this year before today.
Peginesatide would be Palo Alto, California-based Affymax’s first product if it gains FDA approval. The therapy would compete with Amgen’s Epogen, which generated $2.5 billion in revenue last year, and J&J’s Procrit, with 2010 sales of $1.9 billion. Affymax’s medicine works as well as those treatments and had “similar safety results” for people on dialysis, the patient group for whom Affymax seeks approval, FDA staff said Dec. 5 in a report.
“We don’t have a reason to say no to this drug in the dialysis setting,” Wyndham Wilson, the panel chairman, said after the vote. Wilson is chief of lymphoma therapeutics at the National Cancer Institute’s Center for Cancer Research, in Rockville, Maryland.
Peginesatide, like Epogen, Procrit and Amgen’s Aranesp, is part of a class of drugs known as erythropoiesis-stimulating agents that boost production of red blood cells.
The FDA recommended in June that doctors use the lowest possible doses of the agents because of potential heart risks. The agency in 2006 first warned that high doses of the anemia drugs may cause heart attacks and strokes.
Peginesatide proved noninferior to Epogen, Procrit and Aranesp in late-stage clinical trials and had similar risks of death, stroke and heart attacks in dialysis patients, Affymax said today in presentations to the panel. The trials consisted of 2,609 patients.
Peginesatide’s effects last longer than approved treatments, making it more convenient and less expensive to administer, according to Affymax’s September quarterly report. The drug can used once a month, compared with an initial dose of three times weekly for Epogen.
Affymax is co-commercializing peginesatide in the U.S. with Osaka, Japan-based Takeda Pharmaceutical Co. (4502)
Teva Pharmaceutical Industries' (NASDAQ:TEVA) Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women.
In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.
FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.
Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc.
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that an oncology supportive care nurse, Michelle Devries, was interviewed this week on the WWSB-ABC Tampa News at Noonsegment covering the common side effects of cancer treatments, specifically oral mucositis, and the positive clinical benefit seen when using MuGard.
The Amacore Group, Inc. (PINKSHEETS: ACGI), a leader in providing health and health-related programs and other innovative and high-quality solutions, today announced a change in management and its Board of Directors.
AstraZeneca (NYSE:AZN) announced today that it will reduce its U.S. sales force by approximately 1,150 leadership positions and sales representatives as part of the company’s ongoing strategy to operate its business more efficiently to best serve patients in the United States.
Bio-Reference Laboratories, Inc. (NASDAQ: BRLI) announced today it plans to issue earnings results for the fourth quarter and fiscal year 2011 before the open of market trading on Thursday, December 8th, 2011.
Coronado Biosciences, Inc., (OTCBB: CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Bobby W. Sandage, Jr., the Company's President, Chief Executive Officer and Director, will present at the Oppenheimer 22nd Annual Healthcare Conference on Wednesday, December 14, 2011 at 10:30 AM ET.
Enzo Biochem, Inc. (NYSE:ENZ), will hold a conference call to discuss fiscal 2012 first quarter results on Tuesday, December 13, 2011, at 8:30 AM E.T.
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that management will be presenting at the Oppenheimer Annual Healthcare Conference in New York.
IDenta Corp. (PINKSHEETS: IDTA) CEO Yaacov Shoham today made the following announcement: Mr Shoham stated, "We have recently signed a long term agreement with a company from China -- regarding China, Hong Kong and Macao.
InterMune, Inc. (NASDAQ: ITMN) today announced that Dan Welch, Chairman, Chief Executive Officer and President of InterMune, will present at the Oppenheimer & Co. 22nd Annual Healthcare Conference in New York City on Wednesday, December 14, 2011, at 3:55 p.m. EST.
K-V Pharmaceutical Company (NYSE: KV.A/ KV.B) (the "Company" or "K-V"), today commented on the settlement of false claims allegations with the U.S. Department of Justice ("DOJ") associated with the Company's former ETHEX generic pharmaceutical subsidiary.
Neoprobe Corporation (NYSE Amex: NEOP) today announced that Dr. Mark Pykett, President and Chief Executive Officer, will participate at the Oppenheimer & Co. 22nd Annual Healthcare Conference.
Oncothyreon Inc. (Nasdaq: ONTY) announced today that Robert Kirkman, M.D., President and Chief Executive Officer, will be presenting at the Oppenheimer 22nd Annual Healthcare Conference in New York on Wednesday, December 14, 2011 at 2:45 p.m. Eastern Standard Time.
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the Oppenheimer 22nd Annual Healthcare Conference on December 14, 2011 at 1:35 PM EST.
ProtoKinetix (OTCBB: PKTX) (www.protokinetix.com) is pleased to announce results from Areta International laboratory in Italy.
Sigma-Aldrich® Corporation (Nasdaq: SIAL) today announced that Sigma Advanced Genetic Engineering (SAGE™) Labs, an initiative of Sigma Life Science, has made available three genetically modified rat models that exhibit features key to studying conditions such as obesity, diabetes, atherosclerosis, high cholesterol, hypertension and familial hypercholesterolemia.
Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, announced that Ashleigh Palmer, President and Chief Executive Officer, will be presenting a corporate overview at the 22nd Annual Oppenheimer Healthcare Conference being held in New York City.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced that sales of its Purifine® phospholipase C (PLC) enzyme product will now also be targeted for use in pretreatment of oil for biodiesel production.
VistaGen Therapeutics, Inc. (OTCBB: VSTA), a biotechnology company applying stem cell technology for drug rescue and cell therapy, and Synterys, Inc., a medicinal chemistry and collaborative drug discovery company, have entered into a strategic medicinal chemistry services agreement.