FDA grants Repligen orphan drug designation. After the bell Neurocrine Biosciences soars on Phase II study results Print E-mail
By BioMedReports.com Staff   
Monday, 24 May 2010 18:49
Below is a list of the companies that made news in the healthcare sector on Monday, May 24, 2010.

Neurocrine Biosciences, Inc. (Nasdaq:NBIX) shares soared in the after hours session today after the company announced statistically significant and clinically meaningful top-line efficacy results from its Phase II Daisy PETAL study using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

Endometriosis causes parts of the uterine lining to grow outside the womb, which can result in sticking to other organs. The condition may cause infertility and currently has no cure.

"The Daisy PETAL study was successful, all primary and secondary efficacy endpoints were met, and provided exactly the information we need to move this program forward," said Chris O’Brien, M.D., Chief Medical Officer at Neurocrine. "We now have confirmation that the daily scales for menstrual and non-menstrual pelvic pain, developed with extensive input from the FDA and patients, function well in a clinical trial setting. These daily endpoints reflect the way women with endometriosis experience their symptoms and also demonstrate improvement with elagolix."

The company reported that elagolix was found to be generally safe and well tolerated with the most common adverse side effect being nausea.

Shares of Neurocine surged nearly 50% in the after hours market, closing at $4.04, $1.31 higher.

In news from earlier in the day:

Repligen Corporation (Nasdaq:RGEN) announced today that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation to RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor for the treatment of Friedreich's ataxia. Orphan drug designation qualifies Repligen to receive seven years of marketing exclusivity in the United States if the company is the first to obtain marketing approval for RG2833 for the treatment of Friedreich's ataxia, a degenerative disorder of the nerves controlling muscle movements in the arms and legs and the nerve tissue in the spinal cord.

Shares initially spiked higher on the news, reaching $3.70 in early morning trading before sliding back in the afternoon, ultimately closing the day at $3.19, down 2 cents.

Abbott (NYSE: ABT) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new FreeStyle Lite blood glucose test strips. The new FreeStyle Lite test strips minimize interference during blood glucose testing and are designed to offer a better testing experience. The new FreeStyle Lite test strips do not use the GDH-PQQ enzyme, which can be affected by common non-glucose sugars. The new FreeStyle Lite test strips use a GDH-FAD enzyme which is unaffected by common non-glucose sugars, such as maltose or galactose, and minimizes the potential for other interference.

Biogen Idec (NASDAQ: BIIB) and Abbott (NYSE: ABT) today announced enrollment of the first patient in a global Phase III study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX ) in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). The trial, called DECIDE, will investigate a subcutaneous formulation of daclizumab intended for monthly administration, which has the potential to provide a new immunomodulatory approach for treating MS. Under the terms of the collaboration agreement, Biogen Idec will make a $30 million milestone payment to Abbott. This payment is due upon enrollment of the first patient in the DECIDE trial.

Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration has accepted for filing the Company’s New Drug Application (NDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT receptor partial agonist. The NDA will be subject to a standard review.

"The acceptance of the NDA for review by the FDA is another positive step toward our goal of bringing vilazodone to market, and if approved, vilazodone will offer a novel treatment to the millions of people suffering from depression," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. The NDA submission is based on a comprehensive development program for vilazodone, which included two randomized, double-blind, placebo-controlled Phase III clinical trials. In both of these eight-week trials, the efficacy of vilazodone was shown to be superior to placebo with statistically significant results for the primary endpoint and for multiple secondary measures of the symptoms of depression. Results from efficacy measures in an uncontrolled 52-week study were consistent with these findings. The NDA is supported by a database of nearly 2,900 subjects.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical products in China, announced today an exclusive distributor agreement for HEYER Medical's Cumulus ultrasonic nebulizer in China. Dehaier is authorized to distribute all models of this product.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP) announced today the acquisition of a currently approved Abbreviated New Drug Application (ANDA) for hydromorphone hydrochloride 8 mg tablets from Mikah Pharma LLC. The hydromorphone hydrochloride tablets are the generic equivalent of Dilaudid(R) 8 mg. The brand product and its generic equivalents had annual sales of approximately $28 million in 2009 and there are currently four other approved generic manufacturers plus the innovator. The transfer of the ANDA will begin immediately and Elite expects to begin manufacture of the product later in the year.

"This acquisition continues our strategy of leveraging the manufacturing expertise of the company into products that can generate positive cash flow to support our research activities. We hope to be able to announce other such product acquisitions in the future," stated Elite Chairman and CEO Jerry Treppel.

Gentiva Health Services, Inc. (Nasdaq:GTIV) and Odyssey HealthCare, Inc. (Nasdaq: ODSY) announced today that they have entered into a definitive merger agreement whereby Gentiva will acquire Odyssey in an all cash transaction for a price of $27 per share of Odyssey common stock, for an aggregate purchase price of approximately $1.0 billion.

Founded in 1996 and based in Dallas, Texas, Odyssey is one of the leading providers of hospice care in the US in terms of both average daily patient census and number of locations. Gentiva, which is among the leading home healthcare providers in the US, anticipates that the combination of Odyssey's and Gentiva's existing hospice operations will create a leading hospice care provider in the US, with a combined average daily patient census of approximately 14,000 and operations in 30 states. Additionally, we anticipate the combination of the two companies will create the largest US healthcare provider focused on home health and hospice services.

Based on results from continuing operations for the respective companies' 2009 fiscal years, we anticipate that the combination of Gentiva and Odyssey will create a company with more than $1.8 billion in annual revenue, comprised of approximately 60% in home healthcare revenue and approximately 40% in hospice revenue. Gentiva expects the transaction to be accretive to adjusted earnings per share, exclusive of one-time costs, within the first 12 months following closing.

ICON plc, (NASDAQ:ICLR) (ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has acquired Timaq Medical Imaging, a leading European provider of advanced imaging services to pharmaceutical and biotech firms. "The acquisition of Timaq will complement our existing US operations by giving ICON a European base for our Medical Imaging operations," commented Ted Gastineau President, ICON Medical Imaging. "Alongside the immediate access to an experienced imaging team, Timaq's strong links to leading medical institutions gives us access to important scientific expertise in the imaging field that will bring significant benefits to our clients."

ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that there will be several clinical data presentations for compounds utilizing the Company’s Targeted Antibody Payload (TAP) technology at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago on June 4-8, 2010.

"These presentations at ASCO will include the first clinical data for our IMGN388 compound for solid tumors, and also the first data for a TAP compound used in a combination regimen," commented Daniel Junius, President and CEO. "Our clinical pipeline not only continues to grow through progress with additional TAP compounds, but also to mature through an increase in planned and ongoing advanced clinical trials."

Marshall Edwards, Inc. (NASDAQ:MSHL), a specialist oncology company focusing on the clinical development of novel anti-cancer therapeutics, announced today that on May 18, 2010 it received a notice from Nasdaq indicating that the Company failed to comply with the minimum stockholders' equity.

Neuralstem, Inc. (NYSE Amex: CUR) updated the progress of its ongoing Phase I human clinical trial to treat ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing the safety data from the first cohort of three patients, the Safety Monitoring Board has approved moving to the next cohort and transplantation of the fourth patient. The first cohort of patients received five injections of the Company's spinal cord stem cells on one side of the spinal cord. The second cohort of three patients will receive ten injections, five on each side of the cord.

The FDA-approved Phase I trial to evaluate the safety of Neuralstem's spinal cord stem cells in the treatment of ALS has been underway since January, 2010. The trial will ultimately consist of up to 18 ALS patients, who will be examined at regular intervals post-surgery, with final review of the data to come six months after the last patient is treated.

Novavax, Inc. (Nasdaq:NVAX) announced today the appointment of Mark O. Thornton, M.D., M.P.H., Ph.D., as the company's Senior Vice President, Development and Chief Medical Officer. Before joining Novavax, Dr. Thornton was a medical officer in the U.S. Navy and the U.S. Food and Drug Administration's (FDA) immunology and infectious diseases branch and division of therapeutic biologic oncology products, Chief Medical Officer of ZioPharm Oncology, Inc., Managing Director of clinical and regulatory affairs at Angiotech Pharmaceuticals, Inc. and, most recently, Senior Vice President of product development at GenVec, Inc.

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) a biopharmaceutical company focused on the treatment of serious infections such as Clostridium difficile infection (CDI), and Biocon Limited (NSE: BIOCON), one of India's premier biotechnology companies and a global provider of manufacturing services, announced today that they have entered into a long-term supply agreement for the commercial manufacturing of the active pharmaceutical ingredient fidaxomicin, Optimer's lead product candidate for the treatment of CDI.

Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced plans to submit a Phase III trial design for DAVANAT to the U.S. Food and Drug Administration (FDA) during the second half of 2010. The Company has added the talent of Peter G. Traber, M.D., to its FDA approval strategy and trial design team. Dr. Traber is a respected researcher, medical, regulatory and clinical expert, and serves on the Company’s Board of Directors.

"Dr. Traber brings to the Pro-Pharmaceuticals team years of successful experience in drug development and approval. He has gained a thorough understanding of our trial results and our products," said Theodore D. Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "We believe Dr. Traber to be a valuable asset in producing a comprehensive Phase III design with a greater probability of a successful FDA approval."

PURE Bioscience (NASDAQ:PURE) today announced the direct sales channel launch of its revolutionary silver dihydrogen citrate (SDC)-based disinfectant, IV-7 Ultimate Germ Defense (IV-7).

Quest Diagnostics Incorporated (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration has issued 510(k) clearance to the Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is the first to be cleared by the FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that in a preclinical research paper published in the May 2010 issue of the Journal of Neurosurgery, scientists found that the systemic administration of thymosin beta 4 (Tb4) significantly reduced brain tissue damage and improved brain function in rats with traumatic brain injury, or TBI. In the study, 10 rats were injected with Tb4 one day following the inducement of TBI and four times thereafter over a 12-day period, while 9 rats were injected with a placebo or saline solution. In the group of rats treated with Tb4, researchers observed reduced cell loss in the hippocampus, a part of the brain that plays an important role in long-term memory, as compared to the placebo group. The rats treated with Tb4 also experienced growth of new blood vessels and neurons in the injured cerebral cortex, growth of brain cells known as oligodendrocytes in the CA3 field of the hippocampus, and recovery of sensory and motor functions as well as spatial learning. The researchers noted that the data for the first time demonstrate that delayed administration of Tb4 significantly improves histological and functional outcomes in rats with TBI, indicating that Tb4 has considerable therapeutic potential for patients with TBI.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announced today that the results of a joint study with the NYU Langone Medical Center were published on May 12th, 2010 in the online issue of The Journal of Biological Chemistry. The study "Pro-tumorigenic Effects of miR-31 Loss in Mesothelioma," demonstrates the potential of miR-31 to be used for the development of new therapies against mesothelioma and other cancers.

Sangamo BioSciences, Inc. (Nasdaq:SGMO) announced today that data from research and preclinical programs focused on the development of zinc finger DNA-binding protein (ZFP) Therapeutics were described in fifteen presentations given by Sangamo scientists and collaborators at the 13th Annual Meeting of the American Society of Gene and Cell Therapy. "Sangamo's ZFP technology provides an exciting new approach for the development of novel human therapeutics," said Luigi Naldini, M.D., Ph.D., Director of the San Raffaele Telethon Institute for Gene Therapy, Milan, and the principal investigator on several papers presented at the meeting. "ZFP nucleases (ZFNs) enable us to edit the human genome with unprecedented specificity and efficiency. This opens the way to correction of inherited mutations, a potentially revolutionary approach as it can restore a gene's function while preserving its natural regulation, likely overcoming the risks associated with random gene addition approaches. We are using this technology to investigate novel therapies for monogenic diseases and cancer."

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced that they have completed enrollment of a phase II clinical trial of brentuximab vedotin (SGN-35) for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, which is highly expressed on ALCL cells.

Senesco Technologies, Inc. (NYSE Amex: SNT) today announced that Leslie J. Browne, Ph.D., an accomplished executive in biopharmaceutical drug development and clinical research, has been named President and Chief Executive Officer of the Company, effective as of May 25, 2010. Dr. Browne, age 60, succeeds Jack van Hulst, who has served as Senesco’s CEO since November 2009 and remains a Director of the Company.

Somanetics Corporation (Nasdaq:SMTS) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to expand features on its Vital Sync™ bedside monitor and research data aggregation system. The clearance allows for interface with a broader range of bedside devices, display of derived parameters of calculated clinical indices, and an automated events trigger to alert clinicians when patient parameters fall outside desired thresholds.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that clinical activity seen in the first stage of its trial for STA-9090 in Stage IIIB and Stage IV patients with non-small cell lung cancer (NSCLC), support advancing to the second stage of the trial. This result was achieved in the first pre-defined patient cohort to complete enrollment. STA-9090 is a potent small molecule Hsp90 inhibitor with a novel chemical structure that has shown strong activity in a broad range of solid tumor and hematologic cancer models including lung, prostate, colon, breast, gastric, pancreatic, melanoma, AML, and CML. STA-9090 is currently being evaluated in eight ongoing clinical trials, including Phase 2 trials in NSCLC, gastrointestinal stromal tumors, colon cancer, gastric cancer, and AML. Synta expects a total of up to 15 trials for STA-9090 by the end of 2010 and is targeting initiating one or more Phase 3 registration trials for STA-9090 in 2011.

Volcano Corporation (Nasdaq:VOLC) announced today the company's plans to highlight its new product launches, presence in live cases, and participation in late breaking trials during EuroPCR from May 25 – 28 in Paris.

"Through both imaging and therapy, Volcano continues to lead the way in providing innovative solutions to best meet the complex needs of the interventional vascular physician and their patients," said Michel Lussier, Group President for Advanced Imaging Systems, Scientific Affairs, and Volcano Europe, Africa, and the Middle East (EAME). "We look forward to furthering the most progressive year of internally-developed technological innovations our company has seen yet that address the limitations of angiography. Not only do we continue to launch new-to-the-world technologies, we are also pleased to further optimize already commercialized intravascular ultrasound (IVUS) and fractional flow reserve (FFR) products to make some of our best products even better."

Watson Pharmaceuticals, Inc. (NYSE:WPI), today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC's VALTREX tablets. Watson intends to begin shipping the product shortly.

VALTREX 500 and 1000 mg had total U.S. sales of approximately $1.8 billion for the twelve months ending March 2010, according to IMS Health. Valacyclovir hydrochloride tablets are indicated for treatment of cold sores (herpes labialis), initial episodes of genital herpes in immunocompetent adults, recurrent episodes of genital herpes in immunocompetent adults, chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults, the reduction of transmission of genital herpes in immunocompetent adults, and the treatment of herpes zoster (shingles) in immunocompetent adults.

Also Monday:

Aoxing Pharmaceutical Company, Inc. (NYSE Amex:AXN), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced that the Company will be presenting at the UBS Global Specialty Pharmaceuticals Conference at 11:30 AM BST on June 3, 2010 in London.

Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, today announced the availability of a new series of video taped interviews of CEO, Clayton Hardman where he presents the world's first handheld Integrated Optical Biosensor (IOBS), which was recently licensed under an agreement with Los Alamos National Security LLC.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, today announced the launch of the BioPlex® 2200 MMRV IgG kit for use on the company's BioPlex® 2200 system.
Celgene Corporation (NASDAQ: CELG) today announced its presentation at the Citi Global Health Care Conference on Wednesday, May 26, 2010 at 11:00 a.m. ET will be webcast live and will be available in the investor relations section of the company’s Web site at www.celgene.com.
China Yongxin Pharmaceuticals Inc. (OTC Bulletin Board: CYXN), one of the leading health products distribution and retail sales companies in China, today announced its financial results for the first quarter ending March 31, 2010.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Company has added two regulatory affairs executives to its development team.Donald Handley has been appointed Director of Regulatory Affairs, and Ann Hards, Ph.D., has been appointed Vice President of Regulatory Affairs.
Fero Industries, Inc. (OTCBB: FROI) is pleased to announce that Alan M. Schechter and Walter D. Wallach have been retained by the Company to assist in the due diligence and the acquisition of Sucanon® from Gvest, Inc.
Genzyme Corporation (NASDAQ: GENZ) announced today that the terms for the consent decree regarding the Allston manufacturing plant have been finalized.
ICON plc, (NASDAQ:ICLR) (ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has acquired Timaq Medical Imaging, a leading European provider of advanced imaging services to pharmaceutical and biotech firms.
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer of novel acute care pain products, today announced that Therabel Pharma UK Limited, a subsidiary of Therabel Pharma N.V. and Javelin's licensee of commercial rights to Dyloject (diclofenac sodium) in the European Union recently informed Javelin and publicly announced that it is withdrawing all batches of Dyloject (diclofenac 75mg/2ml) from the UK market with a Drug Alert Class 2 Medicines Recall.
Newport Corporation (Nasdaq: NEWP) today announced that it will present at the B. Riley & Co. Investor Conference tomorrow, May 25, 2010, at 3:30 pm Pacific time.
PPD, Inc. (Nasdaq: PPDI) announced today its board of directors has set the shareholder of record and distribution dates in connection with the spin-off of its wholly-owned subsidiary, Furiex Pharmaceuticals, Inc.
SDIX (Nasdaq: SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic and food safety applications, today announced that Wayne P. Yetter has been elected to the Board of Directors, effective May 18, 2010.
SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, announced today that the Company has received a purchase order for protein-based nutraceutical products in India.
SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that REPEL-GYN™, the company's bioresorbable adhesion barrier film for the reduction of adhesions following gynecologic surgery, has received CE Mark approval in the European Union (EU).
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