|Derma soars on strong Phase II results. Hansen Medical surges on Phillips agreement. Marina Biotech higher on license agreement|
|By BioMedReports.com Staff|
|Thursday, 03 February 2011 19:45|
After the bell, pSivida Corp. (NASDAQ:PSDV) reported that its licensee, Alimera Sciences, Inc. (Nasdaq:ALIM) announced month 36, top-line results for the FAME Study. The study consisted of two 3-year, Phase III pivotal clinical trials to assess the safety and efficacy of ILUVIEN in the treatment of Diabetic Macular Edema (DME).
DME is the primary cause of vision loss associated with diabetic retinopathy, a disease affecting the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME.
Alimera reported a statistical significance was seen in both trials as late as month 33. "We believe the statistical significance observed in both trials at month 33 meets the criteria for replication of efficacy in the two studies," said Susan Caballa, senior vice president of regulatory affairs at Alimera. "We will provide this safety and efficacy data to the FDA so that it will have the opportunity to review it as part of our pending NDA for ILUVIEN for the treatment of DME."
In extended trading, shares of Alimera traded down 19 cents to $9.95 while pSivida fell 41 cents to $4.42.
Shares of Derma Sciences, Inc. (Nasdaq:DSCI), surged today after the medical device and pharmaceutical company focused on advanced wound care, announced positive results from its Phase II clinical trial with DSC127 in patients with diabetic foot ulcers. The company said the drug met the trial’s primary endpoint, the proportion of study ulcers healed by 12 weeks as defined by 100% epithelialized with no drainage. DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon injury to tissue. The company said the drug was well-tolerated and there were no significant adverse events associated with the treatment. Derma went on to say that potential partners could emerge for the drug within six to nine months and that the drug could eventually bill around $200-300 million per year worldwide. Estimated launch for the drug is pegged at 2014-15.
Shares of Derma gained $2.28 or 34% to $8.95.
On heavy volume, shares of Hansen Medical, Inc. (NASDAQ:HNSN) soared today after the company announced that it has entered into patent and technology license, sublicense and purchase agreements with Philips Healthcare to allow them to develop and commercialize the non-robotic applications of Hansen Medical's Fiber Optic Shape Sensing and Localization (FOSSL) technology.
According to the agreement, Hansen will receive up front payments of $29 million and will be eligible to receive up to an additional $78 million in future payments associated with the successful commercialization or licensing by Philips or its collaborators of products containing FOSSL technology.
Hansen is a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement. Shares surged 62 cents or 40% to $2.20. Nearly 14 million shares traded hands.
Shares of Marina Biotech, Inc. (NASDAQ:MRNA) saw strength today after the company announced that they entered into an exclusive agreement concerning the development and commercialization of Marina Biotech's pre-clinical program in bladder cancer with The Debiopharm Group, a global independent biopharmaceutical development group of companies with a main focus in oncology and serious medical conditions. Debiopharm and Marina Biotech will work together to advance to market an RNAi-based therapy for the treatment of non-muscle invasive bladder cancer. Debiopharm will pay Marina Biotech up to $25 million based on predefined research and development milestones as well as royalties on the sales of products resulting from the partnership. In addition, all Marina Biotech research and development costs for the bladder cancer program will be funded by Debiopharm beginning in February 2011.
After hitting an intra-day high of $1.32, shares of Marina finished the day up 11 cents or 10.5% to $1.15.
Abiomed, Inc. (NASDAQ:ABMD) surged more than 20% today after the company reported third quarter fiscal 2011 revenue of $27.2 million, up 19% compared to the same period of fiscal 2010. The company cited strong sales of it's Impella Cardiac Assist Device system reporting that Impella revenue climbed 33 percent to $21.1 million and that U.S. revenue from reorders more than doubled to $16.9 million from $8.2 million.
The Impella system is used during and after surgery to relieve heart failure, allowing surgeons to implant a device that keeps a patient's blood flowing. The company expects higher revenues for fiscal 2011, raising its outlook from $93-97 million to $99-101 million.
In heavy trading, shares gained $2.19 or 21.64% to $12.31.
GlaxoSmithKline (NYSE: GSK) and Theravance, Inc. (NASDAQ:THRX) today announced major milestones in two clinical development programmes focused on new treatments for patients with chronic obstructive pulmonary disease (COPD), a leading cause of chronic illness and death worldwide.
The first is the initiation of the Phase III program for the once-daily LAMA/LABA dual bronchodilator GSK573719/vilanterol ('719/VI), which will evaluate over 5,000 patients globally. Patients are now being enrolled in a large safety study, which will be followed shortly by four large pivotal studies that will compare improvements in lung function between '719/VI, its components, placebo and tiotropium. The program will also include two further studies assessing the effect of '719/VI on exercise endurance.
The second is the start of an extensive study of 16,000 patients to assess the potential for Relovair to improve survival in those with COPD and a history of, or at risk from, cardiovascular disease. Relovair is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist combination treatment, currently under development, comprising fluticasone furoate and vilanterol (FF/VI).
Shares of Theravence surged $1.22 or 5.33% to $24.13.
Hospira, Inc. (NYSE:HSP), the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration approval of Topotecan Injection, the first solution formulation of the oncology drug approved in the United States. The medication is a generic version of Hycamtin, which had 2010 U.S. sales of more than $140 million. Hospira's topotecan is indicated for treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy.
Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX.to) today announced that its subsidiary, Biovail Laboratories International SRL, has signed agreements to acquire all U.S. and Canadian rights to non-ophthalmic topical formulations of Zovirax from GlaxoSmithKline for $300 million. The transaction significantly increases profitability of the brand for BLS which had previously been the exclusive distributor in the United States, and expands BLS' geographic rights to include Canada.
As reported earlier here on BioMedReports, Richard Franco, the Chairman and Chief Executive Officer of DARA BioSciences (NASDAQ: DARA), a biopharmaceutical development company in the business of acquiring promising therapeutic candidates, developing them through proof of concept in humans and subsequently selling or out-licensing them to larger pharmaceutical players, says his company's Phase II drug candidate is getting attention, just as he planned it.