|RxNews Recap for Tuesday 03-30-10. Myriad Genetics denied gene patent. After the bell Depomed submits NDA.|
|By BioMedReports.com Staff|
|Tuesday, 30 March 2010 19:30|
Below is a list of the companies that made news in the healthcare sector on Tuesday, March 30, 2010.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that Judge Robert W. Sweet of the Federal District Court for the Southern District of New York ruled that certain claims covering isolated DNA sequences in seven of the 23 patents covering BRACAnalysis(R) are invalid. Myriad will appeal the decision to the Court of Appeals for the Federal Circuit and will continue to vigorously defend this litigation.
"While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation," said Peter Meldrum, President and CEO of Myriad Genetics. "More importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents."
Shares of Myriad dropped 4.28% or $1.20 to close at $23.70.
In news after the market closed:
Depomed, Inc. (NASDAQ: DEPO) today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.
The application follows the completion of a randomized, double-blind, placebo-controlled Phase 3 study of 452 PHN patients. The study demonstrated that DM-1796 achieved a statistically significant reduction in average daily pain score associated with PHN versus placebo using the numerical Likert pain scale.
Immersion Corporation (NASDAQ:IMMR), the leading developer and licensor of haptics technology, today reported financial results for the fourth quarter and year ended December 31, 2009. In a separate press release, Immersion also announced today an agreement with CAE Healthcare, a division of CAE (NYSE: CAE) (TSX: CAE), a $1.6 billion world leader in simulation and modeling for civil aviation, to license TouchSense technology and acquire its Endoscopy AccuTouchTM, Laparoscopy VR, and Endovascular CathLab VR medical simulator product lines. As part of the agreement, CAE will retain existing manufacturing, operations, research and development, service and support, and sales personnel, and Immersion will grant CAE a non-exclusive worldwide license for the haptic-based technology in medical training applications.
SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) today announced topline results from the company's phase 2 clinical trial of SCV-07 for the prevention of severe oral mucositis (OM) (World Health Organization, WHO scale, grades 3 to 4) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. This proof of concept study was intended to provide an estimate of SCV-07's treatment effect and guide further studies of SCV-07 in addressing this serious unmet medical need. Patients receiving the study's higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset of severe OM, the study's primary endpoint. Patients in the low dose treatment arm (0.02 mg/kg) appeared to do worse than placebo, suggesting that the treatment effect is sensitive to dose. Additionally, SCV-07 was safe and well tolerated with no drug-related serious adverse events reported, indicating that there is potential to administer higher doses of SCV-07 in future clinical studies.
In news from earlier in the day:
AstraZeneca and Abbott (NYSE:ABT) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules which combines Astra's blockbuster cholesterol pill Crestor and Abbott's TriLipix. Abbott's TriLipix is part of a class of drugs called fibrates that raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol. AstraZeneca's Crestor is a statin drug that lowers bad cholesterol while raising good cholesterol. The companies are currently evaluating the CRL, will continue discussions with the FDA to determine next steps with respect to the CERTRIAD NDA and will respond to the agency's request for additional information.
Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceuticals Global Research & Development Center, Inc., U.S., today announced multiple posters on Hematide™/peginesatide have been accepted for presentation at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place April 13-17, 2010 in Orlando, Florida. Hematide is an investigational agent for the treatment of anemia in chronic renal failure
ArthroCare Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today the publication of an important clinical trial demonstrating that patients treated with ArthroCare’s Plasma Disc Decompression (PDD) products experienced reduced pain and better quality of life scores compared to patients treated with the current standard care, epidural steroid injections. Peter C. Gerszten, MD, MPH, Associate Professor of Neurological Surgery, at the University of Pittsburgh Medical Center, and principal investigator of the clinical study commented, "This study provides evidence that patients with low back pain associated with a contained disc herniation achieve better outcomes with Plasma Disc Decompression as compared to conventional treatment with epidural steroid injections." ArthroCare’s PDD products are minimally invasive and can be used in an out-patient basis. The products are used surgically to remove a tiny portion of a contained herniated disc. The products are recommended for those patients with contained herniated discs that have not ruptured. More aggressive surgical options have included laminectomy where portions of a vertebra are removed, or discectomy where most or the entire disc is removed.
Biodel Inc. (Nasdaq: BIOD) announced the appointments of Dr. Errol De Souza as president and chief executive officer and Dr. Charles Sanders as board chairman, effective immediately. Dr. Solomon Steiner, who co-founded Biodel in 2003, will become the company’s chief scientific officer, devoting his full-time attention to the development of Biodel’s product candidates to treat diabetes, and will remain a member of the board. Dr. Sanders is former chairman and CEO of Glaxo and was appointed to Biodel’s board in 2006. Dr. De Souza was previously president and CEO of Synaptic Pharmaceuticals, president and CEO of Archemix Corp., co-founder and chief scientific officer of Neurocrine Biosciences, senior vice president and U.S. site head of drug innovation and approval (R&D) at Aventis and director of CNS diseases research at DuPont Merck; he is currently a board member of several biopharmaceutical companies. With Biodel’s appointment of a non-executive board chairman, the company has eliminated the role of lead director, which had been held by Biodel director Scott Weisman.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the successful completion of the Azur Pharma Elestrin royalty buydown, and financial results for the year ended December 31, 2009. In December 2009, the company announced that it had entered into an agreement with Azur (BioSante’s licensee for Elestrin in the U.S.) to monetize its Elestrin royalty stream and certain potential milestones through a royalty and milestone buydown. In 2009, the company received $1.0 million and the company now reports receiving the balance of $2.16 million in the first quarter of 2010. BioSante maintains the right to receive up to $140 million in sales-based milestone payments from Azur, based on Elestrin reaching certain predefined sales in a calendar year.
Clinical Data, Inc. (NASDAQ: CLDA), today announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI). Currently available adenosine agonists must be used with caution or are contraindicated in patients with asthma and COPD. The high selectivity of Stedivaze offers a potential advantage for the safe use in this population, accounting for approximately 10 percent of the 7.6M MPI tests performed annually.1 The Company is also actively enrolling patients in ASPECT 1, a Phase III trial designed to demonstrate the safety and effectiveness of Stedivaze.
Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose. The sNDA includes data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have a significantly improved chance of survival without a transplant. These patients can also survive a significant number of days longer without transplant, providing patients requiring transplant increased time for a donor organ to become available.
CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it filed an emergency motion for a preliminary injunction against Medafor, Inc. in the United States District Court for the Northern District of Georgia, Atlanta division. CryoLife contends that Medafor is improperly attempting to terminate the exclusive distribution agreement ("EDA") between the parties, and CryoLife has requested that the Court enjoin Medafor from proceeding with the termination.
Encorium Group, Inc. (Nasdaq: ENCO) soared today on no apparent news. Early in the day the stock hit an intra-day high of $5.15, nearly a 150% gain from its previous close of $2.11. Shares settled back down and closed the day at $3.65, up $1.07 or 55%. Trading volume of over 9 million shares was nearly 20 times the daily average. Encorium Group, Inc. is a global clinical research organization (CRO) specializing in the design and management of complex clinical trials and Patient Registries for the pharmaceutical, biotechnology and medical device industries.
Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy.
Icagen, Inc. (Nasdaq:ICGN) reported today its financial results and operational highlights for the fourth quarter and full year ended December 31, 2009. For the fourth quarter of 2009, the Company reported revenues of $1.4 million and a net loss of $3.3 million. For the full year 2009, the Company reported revenues of $9.6 million and a net loss of $12.8 million. As of December 31, 2009, the Company's cash and cash equivalents totaled $18.1 million. "We were pleased recently to announce positive proof-of-concept data in epilepsy for ICA-105665, our novel KCNQ agonist," noted P. Kay Wagoner, CEO. "We look forward to determining next steps in the clinical development of this compound. We were also pleased to renew our collaboration with Pfizer during the third quarter of 2009 and look forward to continued progress in this program, which focuses on three sodium channel pain targets, including Nav1.7, which both we and Pfizer believe are promising."
Lpath, Inc. (OTC.BB:LPTN), the category leader in lipidomics-based therapeutics, announced positive summary results of its dose-escalation Phase 1 clinical trial of the investigational drug ASONEP(TM) in cancer patients with a wide variety of solid tumors. Study results included demonstration that lymphocyte counts in the vascular space were reduced in a dose-related fashion. As such, Lpath achieved an objective established by Merck KGaA (Darmstadt, Germany) and received a $2 million payment according to the terms of Lpath's license agreement with Merck KGaA.
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that its over-the-counter (OTC) pain reliever, Cobroxin, is now available for purchase in CVS. "We are excited to announce the availability of Cobroxin in CVS, as this represents the first major drug store chain to carry Cobroxin nationwide," explained Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. "As an over-the-counter, non-narcotic, and non-addictive analgesic, we believe that Cobroxin will become the treatment of choice among those suffering from moderate to severe chronic pain," he added.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) outlined today the Company's development program for the Company's lead drug candidate, NX-1207, currently in Phase 3 trials in the U.S. for the treatment of benign prostatic hyperplasia (BPH). The drug has been successful in a series of blinded controlled multi-center U.S. clinical trials where it has been found to produce improvements that are about double that reported for currently approved BPH drugs. Positive results from animal studies have shown the potential for the use of high dosages of NX-1207 for the focal treatment of clinically localized prostate cancer and of primary liver cancer (hepatocellular carcinoma or HCC).
Oncolytics Biotech Inc.(TSX:ONC, NASDAQ:ONCY) announced today that the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC) has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN(R) in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lungs (SCC lung cancer). The Principal Investigator is Dr. Alain C. Mita of the CTRC.
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that the Company's Board of Directors has appointed Eric I. Richman to the position of President and Chief Operating Officer. Previously Senior Vice President, Business Development and Strategic Planning, in this new role, Mr. Richman will assume management oversight of all day-to-day operations of the Company.
Pro-Pharmaceuticals, Inc. (OTC: PRWP), a developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that it has granted PROCAPS S.A. exclusive rights to market and sell DAVANAT® to treat cancer in Colombia, South America. Phase ll clinical trial results for late-stage colorectal cancer patients demonstrate that when DAVANAT® is co-administered with the chemotherapy drug 5-FU, survival increased by 46% over the best standard of care and reduced serious adverse events associated with chemotherapy. PROCAPS S.A. is a large, international, privately held pharmaceutical company based in Barranquilla, Colombia.
Sanofi-aventis (EURONEXT: SAN, and NYSE: SNY) announced today that the National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document (ACD) for Multaq(R) (dronedarone) indicating its intention to recommend Multaq(R) use for the management of patients with atrial fibrillation (AF).
Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application (BLA) for KRYSTEXXA™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy. The FDA has deemed the resubmission a complete, class 2 response and has established September 14, 2010 as the PDUFA action date. The FDA also acknowledged that the BLA resubmission contains additional chemistry, manufacturing and controls (CMC), Safety Update, Labeling, Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide submitted in response to the FDA's July 31, 2009 complete response letter.
Valeant Pharmaceuticals International (NYSE:VRX) announced today that its board of directors has authorized the repurchase of up to an additional $500 million of its securities, including its outstanding senior notes, convertible debt or common stock under the securities repurchase program approved in October 2008 and increased in May 2009. This repurchase authorization raises the aggregate repurchase authorization to $1.0 billion from $500 million over a period ending in March 2013. To date, the Company has repurchased approximately $415 million in total of its convertible debt and its common stock out of the $1.0 billion now authorized under the securities repurchase program.
YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), announced that it has received ethics board approval to expand enrolment in its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis, a chronic debilitating condition, where patient's bone marrow is replaced by scar tissue.Ayalew Tefferi, Professor of Hematology at Mayo Graduate School and Chair of the study.
Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP) signed a collaborative development agreement with bioRASI, LLC, a full-service global CRO specializing in the accelerated development of novel therapeutics, to facilitate clinical development for its Cobalamin™-based oral insulin and other Cobalamin-based products.
Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) (www.symbollon.com) is pleased to announce that Iogen™ is now available for sale on Amazon.com®.Iogen™ is a patented dietary supplement for improving women's breast health.
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