|RxNews Recap for Friday 03-19-10. Emisphere Technologies jumps on collaboration. RXi Pharmaceuticals continues to move higher.|
|By BioMedReports.com Staff|
|Friday, 19 March 2010 18:16|
Below is a list of the companies that made news in the healthcare sector on Friday, March 19, 2010.
Emisphere Technologies, Inc. (OTCBB:EMIS) jumped more than 10% today after the company announced that they are joining efforts with Alchemia Ltd. (ASX:ACL) to develop an oral formulation of the anti-coagulant drug fondaparinux with Emisphere’s Eligen® Technology.
Emisphere’s broad-based drug delivery platform, known as the Eligen® Technology, uses proprietary, synthetic carriers to enhance the oral bioavailability of a drug without altering its chemical form or biological activity. Fondaparinux, an anti-coagulant used for the prevention of deep vein thrombosis, is marketed in injectable form as Arixtra® by GlaxoSmithKline. Arixtra has been off patent since 2002 but, due to the complexity of its synthesis, there is currently no approved generic or alternative source of commercial scale active pharmaceutical ingredient ("API"). Alchemia has developed a novel, patent protected, synthesis for the manufacture of fondaparinux at commercial scale. In March 2009, Alchemia’s manufacturing and U.S. marketing partner, Dr Reddy’s Laboratories (NYSE: RDY) submitted an ANDA to the U.S. FDA for a generic version of the injectable form of fondaparinux. Shares of Emisphere closed up 17 cents or 10.38% to finish the day at $1.74.
RXi Pharmaceuticals Corporation (Nasdaq:RXII) shares continued to rise today, moving up another 12.5%. The stock of the biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi) have been on tear the last 9 trading days, moving from the low $5 range to close at $7.70 today. As reported previously here on BioMedReports, rumors continue to swirl regarding a potential partnership. Shares closed up 86 cents and continued higher by 15 cents in the after hours market.
In other news Friday:
Aceto Corporation (Nasdaq:ACET), a global leader in the sourcing, quality assurance, regulatory support, marketing and distribution of pharmaceuticals, nutraceuticals, specialty chemicals and crop protection products, today announced that they have received an email from the USDA stating that the re-testing of the vaccine sample that they received from Aceto in December was satisfactory. In our press release of February 5, 2010, the Company had indicated that they were notified by the USDA this past November that testing of certain samples had been unsatisfactory.
Vincent G. Miata, President and CEO of Aceto commented, "We are very pleased that the USDA has indicated that the re-testing was satisfactory. As we have said in the past, we have submitted all of the information that the USDA has requested in consideration of our application for a permit to import our supplier's canine vaccine with authorization for its distribution and sale in the United States and await their decision. I would like to reiterate that this is a regulatory review and that there is no prescribed timetable for them to make their final decision."
A.P. Pharma, Inc. (Nasdaq:APPA), as reported earlier today on BioMedReports, announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). Shares fell to a low of 85 cents but bounced back closing at $1.21, down 41.26% on the day.
Boston Scientific Corporation (NYSE:BSX) announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS® CRT-D. The panel recommended the expansion include the majority of the studied population of the landmark MADIT-CRT clinical trial, which evaluated the ability of these devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure.
Bovie Medical Corporation (NYSE-AMEX Symbol: BVX), a manufacturer and marketer of electrosurgical products, today announced the Company received clearance from the Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology.
China Sky One Medical, Inc. (Nasdaq:CSKI), announced the receipt of Conformite Europeenne (CE) certification for its Myocardial Infarction and Urine Microalbumin Diagnostic Kits. The CE marking certifies that the two products have met the European Union (EU) health and safety standards and are approved for sale in the 27 EU countries and four members of the European Free Trade Association (EFTA).
The Company also received ISO 9001 and ISO 13485 certifications for its Myocardial Infarction, Urine Microalbumin and Early Pregnancy Diagnostic Kits. ISO certifications set stringent, globally recognized management system standard that enhances its product marketing. The two ISO certifications are valid through October 2014.
Cytokinetics, Incorporated (NASDAQ:CYTK) announced today that the company has opened a Phase IIa "Evidence of Effect" (EoE) clinical trial of CK-2017357 for patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate that has emerged from the company's skeletal muscle contractility program. CK-2017357 selectively activates the fast skeletal muscle troponin complex and increases its sensitivity to calcium, resulting in increased skeletal muscle force. In March 2010, CK-2017357 was granted an orphan-drug designation by the United States Food and Drug Administration (FDA) for the potential treatment of ALS.
Gentium S.p.A. (Nasdaq: GENT) jumped more than 31% on no apparent news today. Volume was more than 40 times the daily average. Gentium S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat VOD. Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as an important complication of stem cell transplantation. Certain high-dose chemo-radiation therapy regimens used as part of SCT can damage the lining cells of hepatic blood vessels and so result in VOD, a blockage of the small veins of the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD).
NMT Medical, Inc. (NASDAQ: NMTI) rose more than 19% today on heavier than normal volume and no apparent news. NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures.
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its international partner for Tarceva® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with stable disease following four cycles of standard platinum-based first-line chemotherapy. A final decision is expected from the European Commission within 45 days. The Food and Drug Administration is expected to make a decision on the advanced lung cancer treatment by April 18.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, today announced that the audit report from its independent registered public accounting firm on its financial statements for the fiscal year ended December 31, 2009, included in the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 16, 2010, contains an explanatory paragraph regarding the Company's ability to continue as a going concern..
Synergy Pharmaceuticals, Inc. (OTC BB:SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the initiation of dosing in a Phase IIa clinical trial of SP-304 in patients with chronic constipation (CC). This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation. The objectives of the Phase IIa clinical trial with SP-304 are to characterize the safety of SP-304 for 14 days in patients with CC and establish doses for the larger planned Phase IIb trial in CC patients.
Theravance, Inc. (NASDAQ:THRX), a biopharmaceutical company with a pipeline of internally discovered product candidates, today announced that it has priced its public offering of 7,500,000 shares of its common stock at a price to the public of $11.50 per share.
ViroPharma Incorporated (Nasdaq:VPHM) today announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy. U.S. Food and Drug Administration in October 2008 for routine prophylaxis against hereditary angioedema (HAE) attacks in adults and adolescents. Cinryze is not approved in the European Union or any of its member states. The company also announced today the launch of 'Ryze Above', an exclusive patient resources program within the company's patient support program, CINRYZESolutions®. The Ryze Above program was created for HAE patients prescribed Cinryze, the first and only drug specifically approved to help prevent swelling and/or painful attacks in teenagers and adults with HAE. .
Valeant Pharmaceuticals International (NYSE:VRX) today announced that it has signed a binding agreement to acquire a private branded generics and over the counter (OTC) company located in Brazil for approximately US$28 million. A large portion of the company's product portfolio is in dermatology and the company had annual sales of approximately US$19 million in 2009. Over the past five years, this company has delivered a compound annual growth rate of nearly 15%. In a separate transaction, Valeant will acquire a new 165,000 square foot manufacturing plant approved to produce solids, semi-solids and liquids for approximately US$28 million. Both transactions, which are subject to customary closing conditions, are expected to close in the second quarter of 2010 and will be collectively accretive to Valeant in 2010.
AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer of advanced polymer materials for a broad range of medical devices, today announced it will be exhibiting at the MEDTEC Europe 2010 Exhibition and Conference being held at the Landesmesse Stuttgart Messepiazza in Stuttgart, Germany, from March 23-25, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.