|Santarus moves higher on BLA submission. BioSante falls on offering. MannKind shares gain despite FDA delay|
|By BioMedReports.com Staff|
|Tuesday, 28 December 2010 19:25|
On heavy volume shares of U.S Drugmaker Santarus, Inc. (NASDAQ:SNTS) moved higher today after the company, along with its partner, Dutch biotech company, Pharming Group NV (NYSE Euronext: PHARM), announced the submission of a Biologics License Application (BLA) to the FDA for RHUCIN, an experimental drug for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). Te company said the safety and efficacy of Rhucin were evaluated in two placebo-controlled studies and are supported by four open label treatment studies.
Santarus will pay Pharming a $5 million milestone payment should the application be accepted by the FDA for review. The drug is already approved and being sold by Pharming in Europe under the name Ruconest. Santarus stock has surged nearly 24 percent since it partnered with Pharming in a $20 million deal in September 2010.
Shares of Santarus shot up to an intra-day high of $3.69 before paring back some of its gains, ending the day at $3.27, up 10 cents or 3.15%
Shares of BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) fell nearly 20% today after the company announced that it will sell $18 million in stock to institutional investors. The company said it expects to raise $16.9 million after expenses and discounts. BioSante said it will use the proceeds to fund its clinical trials for LibiGel, a testosterone gel for woman.
Shares fell 39 cents to $1.61.
Shares of MannKind Corporation (Nasdaq:MNKD) gained today despite the company receiving notice from the FDA that the agency will not be able to complete its review of the company's NDA for AFREZZA by the scheduled action date of December 29th 2010. The FDA will now require about four more weeks to complete its review. MannKind hopes to have the only inhaled insulin on the market for patients with diabetes.
Shares of MannKind hit an intra-day high of $8.89 before settling at $8.23, up 26 cents or 3.26%.
Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD). According to the approval document, Sinovac is required to conduct each phase of the human clinical trials in accordance with SFDA requirements, to conduct studies to assess safety and immunogenicity in the phase I and II clinical trials, and to conduct efficacy study in the phase III clinical trial. Sinovac filed in late December 2009 with the SFDA the application to commence human clinical trials for its inactivated EV71 vaccine.
Cardium Therapeutics (NYSE Amex:CXM) today reported that data from the Company's Matrix Phase 2b clinical study has been accepted for publication in the journal, Wound Repair and Regeneration and provided an update on plans for commercialization of its Excellagen formulated collagen topical wound dressing.
HeartWare International, Inc. (Nasdaq:HTWR; ASX: HIN) today announced that it has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.