|RxNews Recap for Tuesday 03-02-10. CombinatoRX surges on FDA approval. Questcor pops on financial results. Sequenom upgraded.|
|By BioMedReports.com Staff|
|Tuesday, 02 March 2010 19:59|
Below is a list of the companies that made news in the healthcare sector on Tuesday, March 2, 2010.
CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
CombinatoRx will receive a $40 million milestone payment from Covidien based on Exalgo approval and is eligible to receive tiered royalties on Exalgo net sales. Under the terms of the agreements relating to the merger with Neuromed Pharmaceuticals, effective with the FDA approval of Exalgo, approximately 38,609,168 additional shares of CombinatoRx common stock are outstanding, resulting in CombinatoRx having total shares of common stock outstanding following FDA approval of Exalgo of approximately 88,610,640.
"Our considerable product development expertise played a key role in facilitating this successful NDA submission, with the goal of providing much needed relief to those who suffer from chronic pain," commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx. "We will continue to apply our strong development capabilities to the many promising drug candidates in our pipeline going forward."
Shares shot up 32.43% to close the day at $1.47, up 36 cents. Shares hit $1.72 at one point during the trading session.
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) saw its shares soar today after the company reported financial results for the fourth quarter and year ended December 31, 2009 after the bell yesterday. The Company's financial performance in the fourth quarter of 2009 was driven primarily by: * a 223% increase in the number of new paid Acthar commercial prescriptions for the treatment of multiple sclerosis (MS) exacerbations versus the fourth quarter of 2008, * a sequential 56% increase in new paid Acthar commercial prescriptions for the treatment of infantile spasms (IS), and *lower sequential Medicaid usage.
In addition to the financial improvement in the quarter, the Company also received an encouraging initial set of Acthar prescriptions for the treatment of nephrotic syndrome (NS). Also, during the fourth quarter, the FDA accepted for review Questcor's supplemental New Drug Application (sNDA) filing which seeks approval for an indication for Acthar in the treatment of IS.
Shares of Questor ran up 93 cents or 19.42% to finish the day at $5.72.
Sequenom, Inc. (Nasdaq:SQNM) saw its shares continue their recent run after Cantor Fitzgerald analyst Pamela Bassett raised her rating and price target on the company. The stock has been on a run since the middle of February. Bassett upgraded the company to "Buy" from "Hold" and raised her share price target to $16 from $4. The stock closed the day at $8.05, up 16.33%.
In other news Tuesday:
Abbott (NYSE:ABT) and Enanta Pharmaceuticals announced today the advancement of their Hepatitis C (HCV) collaboration into Phase 2 clinical trials. The trial will evaluate three HCV antiviral agents, including the investigational protease inhibitor ABT-450, part of the Abbott-Enanta collaboration, and polymerase inhibitors ABT-333 and ABT-072 currently being developed exclusively by Abbott. Each antiviral agent will be dosed individually in combination with the current standard of care (SOC).
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it will report its unaudited financial results for the fourth quarter and year ended December 31, 2009 on Tuesday, March 9, 2010, after the U.S. financial markets close.
Antares Pharma, Inc. (NYSE Amex: AIS) announced today that it has completed enrollment in the double-blind portion of the Company’s Phase 3 clinical trial of Anturol™, its transdermal oxybutynin ATD™ gel for the treatment of overactive bladder (OAB). Top line data from this pivotal trial, which is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), is expected in the third quarter of this year.
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that Hank Fuchs, M.D., Chief Medical Officer of BioMarin, will present a company update at the Cowen and Company 30th Annual Health Care Conference in Boston on Tuesday, March 9, 2010 at 3:00 p.m. ET.
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients. The belatacept Biologics License Application was submitted to the FDA for an indication of prophylaxis of organ rejection and preservation of a functioning allograft in adult patients receiving renal transplants with use in combination with an interleukin-2 (IL-2) receptor antagonist, a mycophenolic acid (MPA), and corticosteroids.
Capstone Therapeutics (Nasdaq:CAPS) shot up today after announcing that it has completed a limited analysis of a subset of data from one of its two ongoing AZX100 Phase 2a clinical trials in keloid scarring. The clinical trial will continue to its planned 12-month endpoints. "We have met our objectives for this preliminary analysis," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "Following a limited review by our independent statistician of the safety and quality of the dataset, we have been advised to continue the trial. The primary endpoint is the 12-month POSAS score; we expect to report data from this trial during 4Q2010."
Cerus Corporation (NASDAQ:CERS) announced today that Claes Glassell, president and chief executive officer, is scheduled to present a corporate update at the Cowen and Company 30th Annual Health Care Conference on Tuesday, March 9th at 4:30 pm ET. The conference will be held at the Boston Marriott Copley Place.
GeoPharma, Inc. (Nasdaq:GORX) jumped up today after the company announced that the FDA Office of Compliance has completed the evaluation of its Largo, Florida manufacturing facility dedicated to the production of Cephalosporin antibiotics and has indicated, based on the adequacy of the Company's written response, that it is acceptable to manufacture upon FDA approval of its Cephalexin ANDA. Commenting on the milestone GeoPharma CEO Mihir Taneja stated, "The approval of this facility has been long anticipated. We are so pleased to have finally gained the endorsement of our facility by the FDA and we look forward to the related Cephalexin ANDA approval during the fiscal year ending March 31, 2011.
Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK) announced today the signing of a definitive agreement under which Hi-Tech acquired the Mag-Ox® line of Magnesium Nutritional supplements from Blaine Company, Inc., a privately held company for $4.1 million in an all-cash transaction. Under the terms of the acquisition Hi-Tech receives rights to Mag-Ox®, Maginex®, Uro-Mag® and Corban™. The products had net sales of approximately $3.4 million in calendar 2009. The brands will be sold through the Company’s Health Care Products OTC division.
iBio, Inc. (OTCBB: IBPM) announced today the appointment of Major General (ret.) Philip K. Russell, M.D. to its Board of Directors.
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. (Korean Stock Exchange: 011000) has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza.
InterMune, Inc. (Nasdaq:ITMN) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.
"IPF is a debilitating and universally fatal disease that affects as many Europeans as Americans," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Today's MAA submission marks an important first step toward making the first IPF treatment available to patients in Europe. It also represents an important milestone for InterMune, demonstrating our commitment to developing and commercializing new treatments for unmet medical needs, including advancing care for patients with this devastating disease."
Medtronic, Inc. (NYSE: MDT), today announced it will participate in the 30th Annual Cowen and Company Health Care Conference on Tuesday, March 9, 2010, in Boston, MA.
Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall® Capsules. Ursodiol Capsules had U.S. sales of approximately $30 million for the 12 months ending Dec. 31, 2009 according to IMS Health. Mylan's version is available for immediate shipment.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the launch of PROLARIS(TM), a 46-gene prognostic test which quantitatively determines the risk of recurrence in patients who have undergone prostatectomy surgery. For the first time, physicians now have a direct molecular measure of a prostate tumor's capacity to divide and grow by examining the mechanics of growth at the molecular level. PROLARIS is the Company's eighth molecular diagnostic product and the first of two that are planned to be launched this year.
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) shares rose today after the company announced the sale of its royalty rights from sales of REGPARA® (cinacalcet HCl) to a fund managed by DRI Capital, Inc., (Fund) for $38.4 million. Royalties in excess of cumulative royalties of $96 million or 2.5 times the upfront purchase price have been retained by NPS.
"This transaction allows us to access significant capital in a manner that is non-dilutive to our shareholders," said Francois Nader, M.D., president and chief executive officer of NPS Pharmaceuticals. "The proceeds from this sale will support our two registration programs, teduglutide in short bowel syndrome and NPSP558 in hypoparathyroidism."
OmniComm Systems, Inc. (OTCBB:OMCM), a global provider of eClinical solutions, announced today that it was selected by a leading pharmaceutical company to provide OmniComm's flagship EDC Solution, TrialMaster™, for a Phase III study of a drug to test a central nervous system disorder.
Orchid Cellmark Inc. (Nasdaq:ORCH), a leading international provider of identity DNA testing services, today announced that it has been awarded a contract to conduct all publicly funded DNA paternity testing for the State of Michigan.
The multi-year contract begins April 1, 2010 and is extendable for four years beyond its expiration in March 2015. Under the terms of the contract, Orchid Cellmark will be the sole provider of DNA paternity testing services for child support enforcement and children's protective services throughout the entire state.
Pacific Biomarkers, Inc. (OTC Bulletin Board: PBME) ("PBI"), a leading provider of specialized biomarker and contract research services, today announced that Ron Helm, Chief Executive Officer, will present at the ROTH Capital Partners 22nd Annual OC Growth Stock Conference.
"The collected clinical and preclinical data presented to the FDA and to our external scientific advisory board provided compelling evidence for resuming clinical development with elesclomol," said Vojo Vukovic, M.D., Ph.D., Chief Medical Officer, Synta. "The action by the FDA will allow us to further evaluate the potential of elesclomol in treating patients with cancer, incorporating the clinical experience and scientific understanding gained through a full analysis of the most recent data. Based on these results, we expect to initiate one or more clinical trials for elesclomol in the second half of this year. Further details will be announced over the coming months."
The Phase 3 SYMMETRY(SM) trial of elesclomol in metastatic melanoma was suspended in February 2009 based on an interim analysis that identified possible safety concerns.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Court of Appeals for the District of Columbia Circuit has ruled in Teva’s favor be overturning a July 31, 2009, district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's antihypertensive agents Hyzaar® (hydrochlorothiazide; losartan potassium) and Cozaar® (losartan potassium).
YM BioSciences Inc. (NYSE Amex: YMI, TSX:YM), announces that it filed a Form 6K describing that certain US patents for nimotuzumab licensed to YM's majority-owned Canadian subsidiary , CIMYM BioSciences Inc., have become subject to a lien in the United States, pursuant to a court order, to a third party. The lien is a consequence of a dispute unrelated to either YM, its licensor, or the patent owner, the Center of Molecular Immunology (CIM). Counsel has advised the Company that the lien does not affect the exclusive, royalty-free license for nimotuzumab issued by CIMAB S.A. to CIMYM for numerous territories, including the US.
None of the international patents for nimotuzumab for which YM is licensed are affected.
"We do not believe that this situation will have an impact on YM's continuing development of nimotuzumab in the US nor do we expect it to be material to YM," said David Allan, Chairman and CEO of YM. "We issue this press release solely in response to market activity."
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