|RxNews Recap for Wednesday 03-24-10. Gentium surges on phase III results. Novavax jumps on positive safety data. After the bell Salix scores FDA approval.|
|By BioMedReports.com Staff|
|Wednesday, 24 March 2010 19:52|
Below is a list of the companies that made news in the healthcare sector on Wednesday, March 24, 2010.
Gentium S.p.A. (Nasdaq:GENT) soared today after announcing the abstract titled, "Defibrotide prevents hepatic VOD and reduces significantly VOD-associated complications in children at high risk: final results of a prospective phase II/III multicenter study." This Phase II/III, randomized, controlled study evaluated the prophylactic use of Defibrotide in pediatric stem cell transplant (SCT) patients at high risk for veno-occulsive disease (VOD). In the intent to treat analysis (ITT), which included 356 patients, Defibrotide demonstrated a 40% reduction in the incidence of VOD within 30 days after SCT, the primary endpoint of the study.
"The results from the study demonstrated that Defibrotide reduced the incidence of VOD in high risk pediatric patients," stated Dr. Selim Corbacioglu. "SCT patients who develop VOD, regardless of its severity and despite prompt treatment, have a mortality rate four times greater than patients without VOD. We are also very enthusiastic that Defibrotide has the potential to reduce the incidence and severity of acute GvHD, a life threatening complication, which is frequent in SCT and has limited treatment options. We believe that Defibrotide could have a future role for the prevention of GvHD." Shares jumped $1.41 or 77.47% closing the day at $3.23.
Novavax, Inc. (Nasdaq:NVAX) moved higher today after the company announced positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle (VLP) pandemic influenza vaccine. The data showed that safety and immunogenicity of the vaccine were consistent with preliminary results disclosed earlier from the first 500 volunteers of Stage A where the vaccine was found to be well tolerated and immunogenic at all three dose levels tested. Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries. Shares of Novavax lept 10.68% or 25 cents to close the day at $2.59. In the after hours market the stock moved up another 5 cents.
After the market closed Wednesday:
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) surged after the bell today after announcing that the U.S. Food and Drug Administration (FDA) has granted marketing approval for XIFAXAN® (rifaximin) 550 mg tablets for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments.i This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.ii The labeling for XIFAXAN 550 mg tablets includes data on both the risk reduction of overt HE recurrence as well as risk reduction of HE-related hospitalization. Shares were up more than 9% in the after hours session. "HE is a growing health issue among adults suffering from liver disease in the U.S. The imminent availability of XIFAXAN 550 mg tablets signals an important advancement for overt HE patients, their caregivers and the health care community supporting these patients," said Bill Forbes, Pharm.D., Executive Vice President of Research and Development and Chief Development Officer, Salix Pharmaceuticals. Shares traded more than 9% higher in the after hours market, jumping $3.33.
AGA Medical Holdings, Inc. (Nasdaq: AGAM) today announced after the bell that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to evaluate the safety and efficacy of its AMPLATZER® Cardiac Plug, or ACP, to close the left atrial appendage. The trial is designed to demonstrate efficacy in preventing stroke in atrial fibrillation patients who are eligible to receive Warfarin, as well as safety of the device and the procedure..
CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has withdrawn its $2.00 per share proposal to acquire Medafor, Inc. CryoLife previously notified the Medafor board of its intention to withdraw its offer in five business days. Based on the limited information that Medafor has made available to its shareholders, CryoLife continues to believe that the Medafor board's stated strategic rationale for entering into the Magle transaction does not justify the significant dilution suffered by Medafor shareholders.Steven G. Anderson, CryoLife's chairman, president and chief executive officer.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy. "There is a need for better tolerated, more effective therapies for narcolepsy, especially narcolepsy with cataplexy," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "Based upon preclinical data, we believe that APD916 may substantially improve the treatment of these potential orphan indications."
News from earlier in the day:
Aastrom Biosciences, Inc. (Nasdaq:ASTM), moved higher today after the developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, reported that the final patient has been treated in the company's ongoing multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. This patient received intramuscular injections of either Aastrom's tissue repair cells (TRCs) or electrolyte solution (placebo) for the treatment of critical limb ischemia (CLI), the end-stage of peripheral arterial disease. People with CLI face a high risk of amputation and, in some cases, death. Approximately 1 million people in the U.S. suffer from CLI, which results in more than 160,000 amputations each year.
Celsius Holdings, Inc. (NASDAQ:CELH) soared today after the company released the results of the latest clinical study showing Celsius significantly reduces body fat when consumed prior to moderate exercise. This sixth clinical study is part of the ongoing research studies that continue to reveal the benefits of Celsius' MetaPlus® formula. Multiple studies show that Celsius burns calories and provides lasting energy. This latest study finds that Celsius®, when consumed fifteen minutes prior to exercise, helps reduce body fat and build lean muscle as compared to exercise alone.
The Celsius group on average experienced the following benefits: *78% greater fat loss *114% greater decrease in percent body fat *79% greater endurance performance *32% greater resistance to fatigue (increased energy). *5.5 lbs of fat loss
Chief Researcher of the study, Jeffrey R. Stout, PhD., stated, "What is extremely important is that the significant reduction in body fat we observed does not appear to be the result of any differences or restrictions in diet, but rather it appears to be the result of drinking Celsius. Additionally, Celsius proved to be significantly more effective than exercise alone at improving aerobic fitness, and the ability to delay the onset of fatigue. This research has validated that Celsius enhances the benefits of exercise and helps reduce body fat while building lean muscle, resulting in positive changes to positive changes to body composition." Shares of Celsius moved up 18.87% or 57 cents to close the day at $3.59. Volume was 5 times the daily average.
Celera Corporation (NASDAQ:CRA) today announced the publication of data reporting that elderly (over age 70) carriers of the KIF6 gene variant with prior vascular disease received significant benefit from pravastatin (Pravachol®) therapy. Previous research has shown that a variant of the KIF6 gene, a member of the molecular motor protein kinesin family, is associated with up to a 55% increased risk of primary and recurrent coronary heart disease (CHD) events in the placebo arms of the clinical trials, and that this increased risk is virtually eliminated with statin therapy.
Genzyme Corporation (NASDAQ: GENZ) shares were hit hard today after the company announced that the FDA intends to take enforcement action to ensure that products manufactured at the Allston plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant's operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme would also be required to make payments to the government and could incur other costs.
The Allston plant has been hit with problems for many months now. Last year, Genzyme temporarily ceased production at the facility which resulted in worldwide shortages of its two top-selling products, Cerezyme and Fabrazyme.
Genzyme said the consent decree would not disrupt production of those two medications but that its thyroid drug Thyrogen might be affected. Shares closed off $3.77 to $55.33.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced interim results through Week 12 following the end of treatment in a Phase 2b clinical trial conducted by Novartis to evaluate the safety and efficacy of ZALBIN™ (albinterferon alfa-2b), an investigational agent, administered monthly in combination with ribavirin in 391 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C virus. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).
"These interim results may suggest that the efficacy of 1500-mcg albinterferon alfa-2b dosed every four weeks is comparable to the current standard of 180-mcg peginterferon alfa-2a dosed once weekly," said Stephen Pianko, M.D., F.R.A.C.P., Ph.D., Monash University, Melbourne, Australia. "The results of this study in patients infected with genotypes 2 and 3 hepatitis C support continued evaluation of albinterferon alfa-2b dosed every four weeks in a larger Phase 3 program."
Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), shares fell sharply after the company today announced a clinical and regulatory update on its lead product candidate, picoplatin. Following a detailed analysis of primary and updated data from the Phase 3 SPEAR study of picoplatin in small cell lung cancer (SCLC) and an evaluation of the ongoing New Drug Application (NDA) process with the U.S. Food and Drug Administration (FDA), the Company has decided to suspend its efforts to obtain regulatory approval for picoplatin in SCLC at this time. The Company will focus its resources on developing pivotal clinical strategies for picoplatin in small cell lung cancer, as well as colorectal, prostate, and ovarian cancers. Pursuant to this decision, the Company announced that it has engaged Leerink Swann LLC to conduct a comprehensive review of strategic alternatives aimed at enabling the execution of these strategies and optimizing shareholder value. These alternatives could include capital raising alternatives, merger, sale or partnership.
PSS World Medical, Inc. (Nasdaq:PSSI) announced today that its Board of Directors has authorized the purchase of up to three million shares of its total common stock.
ViroPharma Incorporated (Nasdaq:VPHM) today announced that the European Medicines Agency (EMA) has accepted the filing of its Marketing Authorization Application (MAA) for Cinryze for acute treatment and prophylaxis against hereditary angioedema (HAE), which was submitted through the centralized procedure in March 2010. ViroPharma is seeking European approval for both prevention and treatment of acute attacks of hereditary angioedema (HAE).
Also Wednesday:Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, reminds shareholders that James A. Joyce, Chairman and Chief Executive Officer of Aethlon Medical, Inc., will present a corporate update from the NASDAQ Marketsite at the 2010 RedChip New York Equities Conference on March 24, 2010, at the market close (4:00 p.m. EDT).
Agilent Technologies Inc. (NYSE:A) today announced that its entire portfolio of DNA microarrays is now manufactured under ISO 13485 certification, an internationally recognized standard for quality management systems (QMS).
American Bio Medica Corporation (Pink Sheets: ABMC) today announced financial results for the fourth quarter and the year ended December 31, 2009.
Arcadia Resources, Inc. (NYSE Amex: KAD), a leading provider of innovative consumer health care services under the Arcadia HealthCare(SM) and DailyMed Pharmacy program, today announced the healthcare reform bill advanced in the U.S. House of Representatives on March 21st contains important provisions related to medication therapy management (MTM) including a series of grant and pilot programs.
China Medicine Corporation (OTC Bulletin Board: CHME), a developer, manufacturer and leading distributor in China of Western pharmaceuticals, traditional Chinese medicine products, other nutriceuticals, medical devices, and medical formulations, today announced that it will conduct a conference call at 9:00 a.m. Eastern Time on Monday, March 29, 2009 to discuss its fourth quarter and full year 2009 results.
Cord Blood America, Inc. (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, announced today that it has acquired 51 percent of stellacure GmbH, the third largest cord blood banking service in Germany.
Dyax Corp. (NASDAQ: DYAX) today announced that it is offering to sell shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. is acting as the sole book-running manager of the offering with Needham & Company, LLC acting as the co-lead manager.
Emerging Healthcare Solutions, Inc. (Pinksheets:EHSI) today said that they expect to reap many benefits from the Biotech industry’s new 12-year haven from Biosimilar competition that was included in the healthcare reform legislation passed by the US House of Representatives on Sunday.
NexMed, Inc. (Nasdaq:NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced that management will hold a conference call to discuss 2009 fourth quarter and full year financial results and ongoing corporate activities, on Thursday, April 1, 2010 at 1:00 p.m. EDT.