|Teva, BioSante Win FDA Approval; HeartWare Announces Date for FDA Advisory Committee Panel|
|By Staff and Wire Reports|
|Tuesday, 14 February 2012 19:50|
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and BioSante Pharmaceuticals Inc. (NASDAQ:BPAX) won U.S. clearance to sell Bio-T-Gel, a testosterone replacement therapy for men.
The Food and Drug Administration approved the transdermal gel, the agency said in an e-mail. Teva, of Petach Tikva, Israel, will market Bio-T-Gel for men with low testosterone. The condition, known as hypogonadism, can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota.
BioSante, the original developer of Bio-T-Gel, estimates the market for male testosterone products is more than $1.2 billion in the U.S., where hypogonadism affects as many as 5 million men. BioSante, of Lincolnshire, Illinois, licensed the gel to Teva, the world’s largest generic-drug maker, and will receive milestone payments and royalties when the drug is commercialized.
Abbott Laboratories (NYSE:ABT) won FDA approval in April for a testosterone product known as AndroGel and later sued Teva, alleging that Bio-T-Gel infringed the product’s patent. Abbott, of Abbott Park, Illinois, and Teva settled the litigation in December without disclosing the terms, BioSante said Jan. 31 in a statement.
BioSante’s other experimental testosterone product, LibiGel, is a topical treatment applied to the arm for female sexual dysfunction. The company fell 77 percent, the most in 12 years, on Dec. 15 after the drug failed to work better than a placebo in two trials. BioSante said Jan. 31 that it would decide within 90 days whether to continue studying LibiGel.
HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, announced today that a U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the Premarket Approval (PMA) application for the HeartWare® Ventricular Assist System on April 25, 2012.
"Notification of the FDA advisory committee meeting represents continued progress toward our goal of obtaining U.S. approval of the HVAD® System for patients with end-stage heart failure," stated Doug Godshall, President and Chief Executive Officer of HeartWare. "We look forward to discussing the efficacy and safety data for the HVAD Pump with the members of the panel and the FDA review team, and believe that these data underscore the potential utility of the HVAD System in improving treatment outcomes for end-stage heart failure patients."
HeartWare's PMA submission encompasses data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption (IDE) study designed to evaluate the HVAD System as a bridge to heart transplantation for patients with end-stage heart failure. Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will host a live webcast of its quarterly conference call at 8:30 a.m. (ET) on Tuesday, February 28, 2012. Harvey J. Berger, M.D., chairman and chief executive officer, will host the call.
Arno Therapeutics, Inc. (OTCBB: ARNI) announced today that it has signed an exclusive, worldwide licensing agreement with privately held Invivis Pharmaceuticals to develop the investigational drug, onapristone, an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in breast cancer.
Array BioPharma Inc. (NASDAQ: ARRY) today announced the closing of its previously announced underwritten public offering of 23,000,000 shares of its common stock at a public offering price of $2.60 per share, which includes the exercise in full by the underwriters of the over-allotment option to purchase 3,000,000 shares of common stock.
AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) today reported consolidated 2011 financial results and reviewed key progress achieved with its tivozanib and ficlatuzumab development programs in the fourth quarter of 2011.
Biogen Idec (NASDAQ: BIIB) and Stromedix, Inc. today announced that they have entered into a definitive agreement under which Biogen Idec will acquire Stromedix Inc., a privately held biotechnology company focused on innovative therapies for fibrosis and organ failure.
Cannabis Science, Inc. (OTCBB: CBIS), a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce that it has signed a major multi-company acquisition agreement that will boost revenues, strengthen pharmaceutical operations and our management team.
mPhase Technologies, Inc. (OTCBB: XDSL) said today that it has been developing intellectual property based on an innovative platform technology to control the flow of fluids by electronicallymanipulating the way liquids behave when in contact with a solid or porous surface.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Peter N. Kellogg, Merck's chief financial officer is scheduled to present at the Leerink Swann 2012 Global Healthcare Conference in New York City on Feb. 15, at 11:00 a.m. EST.
Oragenics, Inc. (OTCBB:ORNI) announced that a recently completed randomized, double-blind, placebo-controlled, human clinical study with 32 enrolled subjects resulted in a statistically and clinically significant reduction in body weight when healthy, overweight and mildly obese adult volunteers were given daily supplementation of Oragenics’ Weight Loss Agent LPT3-04 over a twelve-week period.
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it plans to release fourth quarter and year end 2011 results on February 28, 2012, before the market opens.
Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today announced that it will be presenting at the upcoming Leerink Swann 2012 Global Healthcare Conference.
Syneron Medical Ltd. (NASDAQ: ELOS), www.syneron.com, the global leader in medical aesthetic products and technology, will launch the much anticipated GentleMax Pro® at the 2012 South Beach Symposium at the Lowes Miami Beach Hotel in Miami, Florida on February 16 - 20, 2012.