|OXiGENE Confirms Orphan Drug Designation for OXi4503; Genzyme's AUBAGIO® Approved in Australia|
|By Staff and Wire Reports|
|Wednesday, 21 November 2012 19:28|
OXiGENE, Inc. (Nasdaq: OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that its product candidate OXi4503 has been granted orphan designation by the US Food and Drug Administration for the treatment of acute myelogenous leukemia (AML). Orphan drug designation qualifies a company for several benefits, including the potential for market exclusivity, development grants, and for certain tax credits.
OXi4503 is a novel, second-generation anticancer agent that combines vascular disrupting activity with direct cytotoxicity. A Phase 1 study of OXi4503 for the treatment of patients with AML or myelodysplastic syndrome (MDS) is currently under way, with support from The Leukemia & Lymphoma Society's Therapy Acceleration Program.
Genzyme, a Sanofi company, (EURONEXT: SAN and NYSE: SNY) announced the Australian Therapeutic Goods Administration (TGA) has approved AUBAGIO® (teriflunomide) 14 mg as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The TGA approval will enable health professionals to prescribe AUBAGIO 14 mg in Australia, which is now the second country to gain marketing authorization for the treatment, following FDA approval in September.
"We are very pleased with the TGA approval of AUBAGIO that makes available a new option for healthcare professionals, and people living with MS in Australia who may benefit from this once-daily, oral treatment," said Bill Sibold, Head of Multiple Sclerosis, Genzyme. "The availability of AUBAGIO in the U.S. and subsequent registration in Australia not only demonstrates our continued progress, it also reflects our commitment to deliver differentiated treatments and provide access for patients globally."
The TGA's approval of AUBAGIO was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries including Australia, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.
"For some people living with MS, the additional burden of injectable therapies administered daily to weekly can sometimes be a struggle," said Associate Professor John King, Senior Neurologist, Royal Melbourne Hospital, who participated in the clinical trials for AUBAGIO. "It is exciting to see a new oral treatment that has been shown to both reduce relapses and slow the progression of disability. This is an encouraging development for the MS community."
AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).
"We welcome the advent of a new oral treatment option for MS patients in Australia," said Professor Bill Carroll, Chairman of MS Research Australia. "It is important for people with MS and their clinicians to have access to a range of well-tolerated and convenient therapies that may reduce the impact of the disease on their lives and suit their lifestyle."
AUBAGIO is marketed in the U.S. and now Australia. Marketing applications for AUBAGIO are under review by the European Medicines Agency (EMA) and other regulatory authorities.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that company management will present an overview of the company at the 24th Annual Piper Jaffray Healthcare Conference in New York, NY.
BD (Becton, Dickinson and Company) (NYSE: BDX), a global medical technology company, announced today that it will present at the 24th Annual Piper Jaffray Healthcare Conference Wednesday, November 28, 2012, at 9:30 a.m. EST.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today that the company's President and CEO Ted Schroeder will present the company's corporate overview on Wednesday, November 28, 2012 at 10:30am Eastern Time (7:30am Pacific Time) during the Piper Jaffray 24th Annual Healthcare Conference at the New York Palace Hotel in New York City.
Cerus Corporation (NASDAQ:CERS) announced today that William “Obi” Greenman, president and chief executive officer, is scheduled to present a corporate update at the Piper Jaffray Healthcare Conference in New York at 9:00 AM ET on Wednesday, November 28, 2012.
CONMED Corporation (NASDAQ: CNMD), a medical technology company specializing in medical devices for surgical markets, announced today that the Company will participate in the 24th Annual Piper Jaffray Healthcare Conference, on Wednesday, November 28, 2012 at 10:30 AM Eastern time.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it will collaborate with Perrigo Company (NASDAQ: PRGO;TASE) on the development, manufacturing and commercialization of an extended topical generic drug product with first to market potential.
Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that Mr. Andy Sheldon, President and Chief Executive Officer of Medicago, will be presenting at the 2012 Piper Jaffray Healthcare Conference.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of BiopumpTM a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced a patent granted by the U.S. Patent and Trademark Office (USPTO) protecting the use of Medgenics’ EPODURE Biopump technology for delivery of erythropoietin (EPO).
Orthofix International N.V., (NASDAQ:OFIX) (the Company) announced today that President and Chief Executive Officer Robert Vaters will present at the Piper Jaffray 24th Annual Healthcare Conference on Wednesday, November 28th at 9:30 AM Eastern Time at The New York Palace in New York, NY.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company dedicated to developing and commercializing first-in-class oncology therapeutics, today announced that it has been issued a United States patent (No. 8,314,100), titled “1-[6,7-substituted alkoxyquinoxalinyl) aminocarbonyl]-4-(hetero) arylpiperazine derivatives.”
Senesco Technologies, Inc. (“Senesco” or the “Company”) (OTC:SNTI) announced that as of Wednesday, November 21, 2012, the Company’s common stock will be quoted on the OTC.QB under the ticker symbol SNTI. Quotes for the Company’s common stock can be obtained on the OTC Markets website, www.otcmarkets.com.
Titan Medical Inc. ("the Company") (TSX VENTURE:TMD)(OTCQX:TITXF) announced today that its presentation time at the 24th Annual Piper Jaffray Healthcare Conference to be held on November 27 and 28, 2012 at The New York Palace Hotel in New York City has been rescheduled to a different time.