RxNews Recap for Wednesday 02-03-10. Auxilium (AUXL) and BioSpecifics (BSTC) jump on FDA approval while LaboPharm (DDSS) drops Print E-mail
By Mary Davila   
Wednesday, 03 February 2010 19:34

Below is a list of the companies that made news in the healthcare sector on Wednesday, February 03, 2010.

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), along with thier partner, BioSpecifics Technologies Corp. (Nasdaq: BSTC),  announced early this morning that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. The Company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March. "With the safety and effectiveness of XIAFLEX demonstrated across multiple clinical trials, physicians can now use XIAFLEX to treat any symptomatic cords in patients with Dupuytren's contracture," said Larry Hurst, M.D., study investigator and Professor and Chair, Department of Orthopaedics at SUNY Stony Brook. "I believe that XIAFLEX, as a new nonsurgical treatment, could potentially become the standard of care for Dupuytren's contracture."

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, also announced the news the today. "We believe that patients afflicted with Dupuytren's contracture will greatly benefit from XIAFLEX, the first pharmaceutical treatment for this disabling disease. We would like to acknowledge the efforts of the scientists and clinicians who have worked with XIAFLEX over many years to usher in a new era of hope for millions of patients that suffer from this condition," stated Thomas L. Wegman, President of BioSpecifics. "We look forward to its commercial launch and to the results of clinical trials of XIAFLEX in other indications." Meanwhile, Pfizer, Inc.,(NYSE:PFE) Auxilium's marketing partner for XIAFLEX in Europe, has stated that the scientific/technical review procedure for the Marketing Authorization Approval (MAA) for XIAFLEX in Europe began in January 2010. Pfizer is responsible for marketing XIAFLEX for Dupuytren's contracture and Peyronie's disease in 27 member countries of European Union and 19 other European and Eurasian countries.

Shares of Auxilium rocketed more than 17% to close the day up $4.88 to $32.96. BioSpecifics saw its shares rise almost 6% closing the day at $28.54 while shares of Pfizer were off around 2%.

Other big movers today:

Home Diagnostics, Inc. (NASDAQ: HDIX), saw its shares soar $5.40 to close at $11.45, up more than 89% as the manufacturer and marketer of diabetes testing supplies, announced today that it signed a definitive merger agreement with Nipro Corporation (Tokyo Stock Exchange and Osaka Stock Exchange Ticker Code 8086), a global manufacturer and distributor of medical devices, pharmaceutical products and medical and glass products headquartered in Osaka, Japan, under which Nipro will acquire all outstanding shares of Home Diagnostics’ common stock, $.01 par value, for a cash purchase price of $11.50 per share (or aggregate consideration of approximately $215 million). The offer price represents an approximately 90% premium to the closing price of Home Diagnostics’ common stock on February 2, 2010, and an approximately 83% premium to Home Diagnostics’ average closing price for the preceding 90 days.

Health Discovery Corporation (OTCBB: HDVY) shares jumped today as the company announced that it has received the final payment that was due under the agreement that settled the Company’s patent infringement lawsuit against Vermillion (Pink Sheets: VRML), formerly known as Ciphergen Biosystems, Inc. In 2006, Health Discovery Corporation sued Ciphergen Biosystems in Federal District Court for infringement of several of its patents covering the use of support vector machines (SVMs) for the discovery of biomarkers. As alleged in the complaint, Ciphergen’s researchers had used SVMs to identify the most promising biomarkers for diagnosis of ovarian cancer, the results of which had been reported in a number of medical publications. The settlement agreement, through which Ciphergen was granted a limited license to continue its use of the Company’s SVM technology only in conjunction with its protein based SELDI mass spectrometry technology, was inked in July 2007. No rights were granted under the license to use HDC's SVM technology for gene-based molecular diagnostic discovery, digital pathology interpretations, digital radiology interpretation nor any other discovery use outside of the very narrow field of SELDI-based protein discovery. Vermillion went on to further develop these biomarkers into the OVA1™ test, which was approved by the FDA in September 2009 and exclusively licensed to Quest Diagnostics. Based on these favorable developments, Vermillion recently emerged from bankruptcy and has enjoyed phenomenal growth in its share prices.

“The results achieved by Vermillion provide further testimony to the value of Health Discovery Corporation’s proprietary SVM technology, both from a technical and a financial perspective,” said Dr. Stephen Barnhill, Chairman and CEO of Health Discovery Corporation. “In addition to our own biomarker discovery programs, we are continuing to pursue revenue-producing licensing opportunities, retroactively, as in the case of Vermillion, and going forward, to develop new applications of the technology within our intellectual property portfolio.” The applicability of SVM technology to countless uses is allowing Health Discovery Corporation to direct its licensing efforts both within and outside of the healthcare arena, including high-tech applications such as Internet search engines, electronic health records, fraud detection, security and surveillance, and fault detection and prediction in vehicles and aircraft.

Shares of Health Discovery closed the day at $.35, up 25% on nearly 10 times the average volume.

In news from after the market close today:

Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, after the bell today announced financial results for its fiscal second quarter ended December 31, 2009.

Revenue in the second quarter rose to $15.1 million, an 8-percent increase over revenue of $14.0 million in the second quarter of last fiscal year. The net loss improved at a higher rate of 22 percent to $(6.8) million, benefiting from improved gross margins and lower operating expenses. Adjusted EBITDA, calculated as loss from operations, less depreciation and amortization and stock-based compensation expense, improved by 39 percent to a loss of $(4.3) million versus $(6.9) million in the year-ago period.

David L. Martin, CSI president and chief executive officer, commented, “Revenue grew in line with our expectation this quarter, while the net loss narrowed significantly through careful expense management. We installed optimal large vessel protocols for using the Diamondback 360° at selected target accounts. The result was an increase in device usage of over 50 percent in those accounts from the first quarter of this fiscal year. Given this success, we have broadened our program substantially for the third quarter of fiscal 2010.” The company’s Diamondback 360® PAD System treats peripheral arterial disease (PAD) in vessels throughout the leg in a few minutes of treatment time.

Inverness Medical Innovations, Inc. (NYSE: IMA), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced after the bell today that it has entered into a binding agreement with Kroll Inc., a subsidiary of Marsh and McLennan Companies, Inc. (NYSE: MMC) to purchase its Substance Abuse Testing division (Kroll Laboratory Specialists, Inc.), its business unit providing forensic quality substance abuse testing products and services across the United States. The purchase price is $110 million cash subject to a customary working capital adjustment. The acquisition is expected to close in the first quarter of 2010 but remains subject to customary closing conditions.

News from earlier Wednesday:

AEterna Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ), a late-stage drug development company specialized in oncology and endocrinology, today announced that its partner, Keryx Biopharmaceuticals ( KERX), has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, perifosine (KRX-0401), in patients with refractory metastatic colorectal cancer.

Affymetrix, Inc., (NASDAQ: AFFX) today reported its operating results for the fourth quarter and fiscal year ended December 31, 2009. Total revenue for the fourth quarter was $88.8 million, as compared to total revenue of $78.6 million in the fourth quarter of 2008.

Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced preliminary results indicating that, in a recently completed Phase 2 clinical trial conducted in Perth, Australia at the University of Western Australia with Professors David Smith and Manfred Beilharz as principal investigators, the rate of influenza-like illness was significantly (p=0.01) reduced from 71% to 43% in interferon-treated subjects who received Fluvax (an influenza vaccine) prior to the study, compared to subjects in the placebo group who were vaccinated.

BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the fourth quarter and full year ended December 31, 2009 on Wednesday, February 10, 2010.

Catalyst Health Solutions, Inc. (NASDAQ:CHSI) announced today that Hai Tran, Chief Financial Officer, and Richard Bates, Executive Vice President, are scheduled to present at the UBS 20th Annual Global Healthcare Services Conference on Tuesday, February 9, 2010, at approximately 8:30 a.m. (ET) in New York City.

CEL-SCI Corporation (NYSE CVM) announced that Geert Kersten, Chief Executive Officer, will be presenting at the 2010 BIO CEO & Investor Conference.

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that Nasdaq notified the Company that it has regained compliance with the minimum bid price requirement in Listing Rule 5550(a)(2) and met the requirements of the Nasdaq Listing Qualification Panel (the “Panel”) decision dated November 2, 2009.

ERT (Nasdaq: ERES), announced today that it will release its results for the fourth quarter and full year 2009 on Thursday, February 25, 2010, after the market closes.

Genzyme Corporation (NASDAQ: GENZ) announced today that Scott Canute, the former manufacturing head at Eli Lilly & Company and a respected leader in the field, joined the company as President of Global Manufacturing and Corporate Operations.

GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced today that Geoffrey Cox, Ph.D., GTC’s Chairman and CEO, is scheduled to present on Tuesday, February 9, 2010 at 8:30 a.m. during the 12th Annual BIO CEO & Investor Conference.

HealthSport, Inc. (OTC Bulletin Board: HSPO), the preeminent formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion, announced today that the Mexican Institute of Industrial Property has approved HealthSport's patent application relating to its bi-layer edible film strip technology.

ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceuticals company that develops targeted anticancer therapeutics using its Targeted Antibody Payload (TAP) technology, invites investors, journalists and the general public to listen to a live webcast of the Company's investment community meeting on February 25, 2010.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.

"OLEPTRO(TM) represents Labopharm's second CONTRAMID(R) technology-based product to receive FDA approval in just over a year," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We are excited about the opportunity for OLEPTRO(TM) and are preparing the product for launch into the $11 billion-plus U.S. antidepressant market. We are working towards finalizing a commercialization path for OLEPTRO(TM) that will maximize the value of our product in this market."

MDD is a common mental illness often characterized by a combination of social and somatic symptoms. It affects more than 14 million adults in the U.S. and is the leading cause of disability globally. OLEPTRO(TM) will offer physicians another therapeutic alternative for their MDD patients. Shares of Labopharm dropped more than 15% on the news.

Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the dermal fillers RESTYLANE®-L and PERLANE®-L. RESTYLANE-L is approved for implantation into the mid to deep dermis, and PERLANE-L is approved for implantation into the deep dermis to superficial subcutis, both for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds

MedLink (OTCBB: MLKNA) announced today the formation of the MedLink Community Physician Advisory Board.

MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) announced today that it is partnering with DoctorDirectory.com, Inc. (DoctorDirectory) to promote MOXATAG through DoctorDirectory’s virtual marketing solution, IncreaseRx®. IncreaseRx® utilizes web-based educational and promotional tactics to reach thousands of prescribers with targeted sales and marketing messages.

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a personalized T-cell immunotherapy for multiple sclerosis (MS), today announced that Neil K. Warma, Opexa’s president and chief executive officer, will deliver a corporate presentation at the 12th Annual BIO CEO & Investor Conference.

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Gregory S. Weisnar, Chief Executive Officer, will make a presentation regarding the Company at the UBS 20th Annual Global Healthcare Services Conference in New York City, on Monday, February 8, 2010, at 9:00 a.m. Eastern Time.

Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that the results of a pre-clinical study in an animal model of ischemic stroke demonstrated that its PLacental eXpanded (PLX) cell therapy may be an effective treatment for this disorder. Results will be published in the journal Brain Research (Brain Research, Feb. 22, Vol. 1315) under the title “Transplantation of placenta-derived mesenchymal stromal cells upon experimental stroke in rats.” The study was conducted in collaboration with the Fraunhofer Institute for Immunology and Cell Therapy (IZI) in Leipzig, Germany. “The study’s positive results suggest that PLX cells may increase the time interval for successful treatment in humans suffering from ischemic stroke, but our knowledge concerning modes of action and optimal treatment paradigms must be enlarged in further experiments before considering clinical application,” said Dr. Johannes Boltze, head of the stroke research group at The Fraunhofer Institute for IZI in Leipzig, Germany and senior author of the publication.

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), said it would cut more than half of its workforce to focus resources on the development of its key cancer drug picoplatin. Poniard also named Ronald Martell its new chief executive officer, succeeding Jerry McMahon, who held the post for about six years.Poniard expects to incur a charge of $1 million related to the job cuts, which brings the company's total number of employees to 21, in the first quarter of 2010.The company expects to cut operating expenses by $4 million in 2010.

The company has been trying to find a partner to market picoplatin to treat lung cancer, an indication in which the drug failed a late-stage study in November 2009.Further development of the drug to treat colorectal cancer and prostate cancer were also pegged on the partnership, which would have funded the late-stage studies of picoplatin in the two other cancer types.

The reduction in force is a difficult but necessary step to preserve our resources as we pursue our goals of establishing a regulatory path forward for picoplatin and evaluating our strategic opportunities for this novel therapy,” said Martell in a statement.

Poniard, however will remain fully staffed to provide clinical support activities and for its meetings with the Food and Drug Administration in the first half of 2010. The company expects $4 million in reduced annualized operating expenses due to the workforce cut. It also expects to acquire a $1 million in the first quarter of 2010 because of the reduction. Shares of Poniard fell 10% to $1.65.

PSS World Medical, Inc. (Nasdaq: PSSI) today announced that its Board of Directors has unanimously appointed Gary A. Corless, currently the Company's Executive Vice President and Chief Operating Officer, as President and Chief Executive Officer, effective immediately. Mr. Corless succeeds David A. Smith, who has terminated his employment with the Company by mutual agreement. Mr. Corless has also been appointed a Director on the Company's Board and a member of the Executive Committee. In addition, Delores P. Kesler, a Director since 1993, has been appointed Chairman of the Board of Directors. Shares of PSSI closed down on the day.

Repligen Corporation (Nasdaq: RGEN) announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering a recombinant form of Protein A which is identical in structure to the commercial form of Protein A from Staphylococcus aureus which is used in the production of many of the world's approved monoclonal antibodies. The patent, which will remain in force until 2028, covers a new Repligen proprietary product which is now available in commercial quantities. This product has been developed as an alternative to the legacy Staphylococcus aureus Protein A and will be the basis of Repligen's future chromatography product development. Proteins manufactured with recombinant technology have multiple advantages over a natural source such as Staphylococcus aureus including higher quality, product consistency and purity as well as improved supply chain security and a lower cost of production.

"This action by the patent office reflects our continuing investment and commitment to our Bioprocessing business," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "This recently launched recombinant Protein A product is an important step in expanding our business through both organic growth and product acquisition."

Sanomedics International Holdings, Inc. (Pink Sheets: SIMH) announced the appointment of Jordan Serlin as Chief Operating Officer for the company. Additionally he will sit on the company’s Board of Directors. Serlin has served as both an advisor to company CEO Keith Houlihan and operational consultant to Sanomedics since September, 2009.

SDI (Strategic Diagnostics Inc., Nasdaq: SDIX), a provider of biotechnology-based products and services, today announced that Dr. Klaus Lindpaintner began serving as Vice President of Research & Development and Chief Scientific Officer (CSO) on February 1, 2010 as previously disclosed in its January 11, 2010 news release.

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients.

ULURU Inc. (Amex: ULU), a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products, today announced it has entered into definitive agreements to sell 5,000,000 shares of its common stock at a price per share of $0.20 pursuant to a registered direct offering to institutional investors, resulting in gross proceeds of $1.0 million. The price per share represents the closing price of ULURU's common stock on February 1, 2010. There were no warrants issued to the institutional investors in this transaction.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 inpatients with cystic fibrosis (CF) who are homozygous for the F508del mutation. VX-809, an oral investigational Cystic Fibrosis Transmembrane Conductance Regulator protein (CFTR) corrector, was well-tolerated across all four dose groups studied.

Vystar® Corporation (OTC Bulletin Board: VYST), the creator of Vytex® Natural Rubber Latex (NRL), a patented, all-natural raw material that significantly reduces antigenic proteins found in natural rubber latex, has engaged The Investor Relations Group ("IRG"), a thirteen-year-old, award-winning, corporate communications firm based in New York City, to serve as its investor relations and public relations agency.

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