|Discovery Labs revalidates BAT. Javelin drops after Hospira extends tender offer. Geron reports positive IPF data|
|By BioMedReports.com Staff|
|Wednesday, 19 May 2010 18:25|
Below is a list of the companies that made news in the healthcare sector on Wednesday, May 19, 2010.
Discovery Laboratories, Inc. (Nasdaq:DSCO) moved higher today after the company announced that the revalidation of its optimized fetal rabbit Biological Activity Test (BAT) has been completed, having met all pre-specified acceptance criteria. The optimization and successful revalidation of the BAT is a key milestone in Discovery Labs' plans to resolve the sole remaining Chemistry, Manufacturing & Control (CMC) issue necessary to potentially gain U.S. Food and Drug Administration marketing approval for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a comprehensive Phase 3 clinical program. In April 2009 the FDA declined approval of Surfaxin citing concerns regarding certain aspects of the BAT.
To complete the comprehensive preclinical program, Discovery Labs will now employ the optimized BAT in a series of prospectively-designed, side-by-side preclinical studies with the well-established preterm lamb model of RDS.
Jerry Orehostky, Senior Vice President, Quality Operations, commented, "We believe that optimizing and revalidating the BAT has improved its performance and increased the likelihood that the results of our preclinical program will demonstrate, to the FDA's satisfaction, a level of comparability between data generated using the BAT and the preterm lamb model."
Discovery Labs has also been communicating with the FDA regarding other important aspects of the comprehensive preclinical program and submitted for FDA review and comment a protocol outlining a proposed study design and success criteria for the side-by-side preclinical studies.
Shares of Discovery Labs closed at 51 cents, up more than 3% on the day.
Hospira, Inc. (NYSE:HSP) today announced the extension of its $145 million, tender offer to purchase all outstanding shares of the common stock of Javelin Pharmaceuticals, Inc. (NYSE - Amex: JAV) for $2.20. Hospira delivered notice of the extension of the tender offer to Javelin based on, what Hospira claims, are unsatisfied conditions of the offer. The offer, which was scheduled to expire Tuesday, has been extended to June 2. Although Hospira did not provide specific information regarding the "unsatisfied conditions," the company stated that it intends to continue to work with Javelin to confirm the satisfaction of the conditions to the offer. Javelin disagrees with the claims and said that Hospira is using a supply chain problem in the UK as an excuse.
Javelin had a deal with Myriad in April to be acquired by that company for in exchange for stock, but reneged, citing the offer as too low.
To date, Hospira has tendered approximately 79% or 51.1 million of Javelins outstanding shares.
Shares of Javelin tanked on the announcement, dropping more than 17% or 38 cents, ending the day at $1.82. Shares of Hospira were off 48 cents to $52.43.
Geron Corporation (Nasdaq: GERN) today announced positive data on its orally available small molecule telomerase activator, TAT153, in an animal model of idiopathic pulmonary fibrosis (IPF). The data show that administration of TAT153 increased telomerase activity in the lung tissue, reduced inflammation, preserved functional lung tissue, slowed disease progression and attenuated loss of pulmonary function.
"This is the first demonstration that a telomerase activator can affect fibrotic disease progression in a model system," said Thomas B. Okarma, Ph.D., M.D., Geron’s president and chief executive officer. "The data indicate that telomerase activation may be a useful therapeutic modality in IPF. Currently, there are no drugs that reduce the fibrotic process in lung disease or other organs. This is a very large unmet medical need."
In other news Wednesday:
Abbott (NYSE:ABT) announced today that the company received Biologic License Application (BLA) approval from the United States Food and Drug Administration for the ABBOTT PRISM Chagas test. The test is a fully automated blood screening assay that can detect antibodies to Trypansoma cruzi (T. cruzi), a parasite found only in the Americas and most commonly acquired through contact with the blood-sucking triatomine or "kissing bug." According to the Centers for Disease Control and Prevention, an estimated eight to 11 million people are infected worldwide with Chagas disease and an additional 108.6 million people are considered to be at risk. If left undiagnosed and untreated, Chagas disease can result in death.
Alkermes, Inc. (NASDAQ: ALKS) today announced that new data from several company-sponsored studies of naltrexone for extended-release injectable suspension (XR-NTX) are scheduled to be presented at the 2010 American Psychiatric Association (APA) Annual Meeting in New Orleans, May 22-26, 2010.
XR-NTX is marketed by Alkermes as VIVITROL and is approved in the U.S. for the treatment of alcohol dependence. The company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the treatment of opioid dependence and, if approved, XR-NTX has the potential to be the first and only non-narcotic, non-addictive drug agent available in a once-monthly formulation.
Allergan, Inc. (NYSE: AGN) today announced that the United States Food and Drug Administration has approved ZYMAXID, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia. ZYMAXID is now the highest concentration gatifloxacin ophthalmic solution on the market in the United States. "As pathogens continue to evolve and become more resistant to antibiotics, it is important to develop more potent formulations of anti-infective drugs," said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development and Chief Scientific Officer.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) reported that the Board of Appeals of the European Patent Office (EPO) has ruled that claims of the Kreutzer-Limmer ’945 (EP 1214945) patent meet needed requirements under European patent law. The ’945 patent comprises broad claims covering the length and certain structural requirements for siRNAs that are important for advancement of RNAi therapeutics.
Antares Pharma, Inc. (NYSE Amex: AIS) announced the receipt of a milestone payment from Ferring International Center S.A. The payment was related to achieving a development-based milestone under the license and asset purchase agreements announced in November 2009 regarding certain intellectual property relating to transdermal gel delivery technology. The amount of the milestone payment was not disclosed.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, "We are pleased to receive this milestone payment from Ferring. Our agreements with Ferring allowed us to focus on our growing parenteral injector business while retaining the potential upside from our marketed and clinical stage transdermal gel programs. At the same time we have been able to reduce our overhead costs and burn rate as we continue to strengthen Antares and execute our strategy".
BIOLASE Technology, Inc. (NASDAQ:BLTI), moved higher today after the leading dental laser company, announced that Discus Dental, LLC and Zap Lasers, LLC filed a First Amended Complaint related to their ongoing lawsuit against BIOLASE, pending in the United States District Court for the Central District of California. The Amended Complaint, which the plaintiffs filed after BIOLASE threatened to file a motion to strike with the Court, dropped the allegation of fraud, as well as certain allegations related to the claims for trademark infringement and unfair competition.
David M. Mulder, Chief Executive Officer of BIOLASE, stated, "We are very pleased that the Plaintiffs dropped their unjustifiable allegations, which we always felt were inappropriate and worthy of being stricken from the complaint. This serves to validate the fact that we run a reputable, professional business that continues to maintain a leadership role in the dental laser industry."
Boston Scientific Corporation (NYSE:BSX) today announced the U.S. and European launches of the Sterling SL PTA Balloon Dilatation Catheter, a high-performance balloon dilatation catheter designed for use in peripheral angioplasty procedures below the knee. The Company plans to launch the product immediately in both markets.
The Sterling SL Balloon Catheter was developed specifically to address physicians' needs in treating below-the-knee arteries by providing a low tip profile, excellent deliverability and rapid deflation time. It expands the Company's leading line of low-profile peripheral angioplasty balloon catheters, which includes the Sterling and Sterling ES products.
Cannabis Science, Inc. (OTCBB:CBIS), a pioneering U.S. biotech company developing pharmaceutical cannabis products, is pleased to announce that as reported in a recent article in USA TODAY the use of marijuana for Medical purposes is becoming more accepted by government officials and by the overwhelming majority of the people. According to the article, "a consensus is growing across the country that at least marijuana will someday be regulated and sold like tobacco and alcohol."
China-Biotics, Inc.(Nasdaq:CHBT), a leading developer, manufacturer and distributor of probiotics products in China, today announced that a number of its probiotics strains appear on the expanded probiotics list for food industry recently approved by the Ministry of Health in China.
China-Biotics currently carries all of the 21 probiotics strains in the list approved by the Ministry of Health. These probiotics strains are widely used in the Company's bulk additive products.
Curis, Inc. (NASDAQ: CRIS) today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NBI), which will become effective prior to market open on Monday, May 24, 2010.
"We are very pleased to be included in the NASDAQ Biotechnology Index, which we believe underscores Curis' consistent progress and achievements over the past year," said Dan Passeri, Curis’ President and Chief Executive Officer. "We are committed to advancing our pipeline programs and look forward to continued momentum as we expect to report several key milestones over the remainder of 2010, including for GDC-0449, a first-in-class Hedgehog pathway inhibitor in collaboration with Genentech, and CUDC-101, an HDAC/EGFR/Her2 inhibitor and our lead proprietary drug."
Enzo Biochem, Inc., (NYSE: ENZ) announced today that Enzo Clinical Labs, Inc., its reference lab division serving physicians and medical facilities in the New York metropolitan area, has entered into a trial co-marketing services agreement with privately-owned MMF Systems, Inc., of New York City, involving MMF’S state of the art medical records system.
GenVec, Inc. (Nasdaq:GNVC) today announced that Mark O. Thornton, M.D., M.P.H., Ph.D., will resign as Senior Vice President, Product Development effective May 23, 2010 in order to accept a position with another company. Paul H. Fischer, GenVec's President and CEO stated, "Over the past three and a half years, Mark made important contributions to the company and we wish him well with his new endeavors."
Heska Corporation (Nasdaq:HSKA) a leading provider of veterinary diagnostic and specialty products, announced today the first installations of the Company's new VitalPath Blood Gas & Electrolyte Analyzer.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) reported that Inspire scientists and collaborators will present data on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during an oral presentation at the American Thoracic Society (ATS) 2010 International Conference May 14 - 19, 2010 in New Orleans, LA. The data suggest that denufosol, an inhaled ion channel regulator, has properties that allow it to reach and improve lung function in the small airways, which may support its potential as an early intervention therapy.
"It is well known that cystic fibrosis lung disease begins in the small airways; however, there has been limited research into treatments that reach these areas of the lungs," said Felix Ratjen, M.D., Ph.D., Professor of Pediatrics and Division Chief, Respiratory Medicine, University of Toronto, and lead principal investigator of TIGER-2. "Since pathological changes in small airways of CF patients are seen as early as six months of age, and mandatory newborn screenings in all 50 states means earlier diagnoses, there is strong need for early intervention treatments in the CF community right now."
Medtronic, Inc. (NYSE: MDT), today announced that the first patient has been treated with the company’s Valiant Thoracic Stent Graft with the Captivia Delivery System in Medtronic’s RESCUE Clinical Study.
Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) announced today that the Company has formalized working relationships with an international cosmetic company and a site monitoring company.
The cosmetic company has agreed to evaluate the patented technology underlying the Company's non-prescription topical beauty care products for potential use in a product line targeted for retail-based channels of trade, including mass market retailers.
The site monitoring company has agreed to assist the Company as it expands into India to initiate new sites for its Phase II-b clinical trial, "A Randomized, Placebo-Controlled, Double-Blind, Single-Dose Escalation Study to Evaluate the Safety and Tolerability of Oxycyte in Patients with Severe, Non-Penetrating Traumatic Brain Injury." Terms of the agreements and identities of the companies involved were not disclosed.
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (NASDAQ: BIIB) today announced their decision to discontinue the ocrelizumab clinical development programme in patients with rheumatoid arthritis (RA).
Following a detailed analysis of the efficacy and safety results from the RA programme, the companies concluded that the overall benefit to risk profile of ocrelizumab was not favourable in RA taking into account the currently available treatment options.
Ocrelizumab is also being evaluated for relapsing remitting multiple sclerosis (RRMS). Treatment in the ocrelizumab RRMS Phase II study is ongoing and data from this study will be submitted for presentation at the upcoming ECTRIMS conference.
Soligenix, Inc. (OTC Bulletin Board:SNGX.ob) a late-stage biopharmaceutical company, announced today that the United States Patent Office (USPTO) has issued a patent (US 7,704,985) entitled "Treatment of Irritable Bowel Syndrome and Related Bowel Diseases." The patent claims the use of beclomethasone dipropionate (BDP) to treat irritable bowel syndrome (IBS). "There is an increasing awareness that IBS results in part from an inflammatory cascade in the GI tract, which makes it amenable to treatment with topically active steroids such as oral BDP," said Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix. "This potentially expands the available treatment options for IBS. The granting of the US patent for BDP in IBS further demonstrates its potential novelty and utility in treating inflammatory GI diseases."
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in adults with attention deficit/hyperactivity disorder (ADHD). TC-5619 is a novel small molecule that is highly selective for the alpha7 neuronal nicotinic receptor, which Targacept refers to as NNR, and was discovered by Targacept scientists using Targacept’s proprietary drug discovery platform known as Pentad (TM). Targacept expects this Phase 2 trial of TC-5619 to complete in the first half of 2011.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that its subsidiary, Teva Canada received a Notice of Compliance from Health Canada to market its generic version of Pfizer’s Lipitor Tablets, a product indicated for lowering cholesterol. Shipment of this product will commence immediately. Lipitor Tablets had annual brand sales of approximately C$1.3 billion in Canada.
Volcano Corporation (Nasdaq:VOLC) announced today it received both 510(k) clearance and CE Mark approval for its PrimeWire PRESTIGE™ Pressure Guide Wire for use with patients who have both single-vessel and multi-vessel disease. This next generation pressure wire is compatible with Volcano's full suite of integrated multi-modality consoles and stand-alone physiology systems as well as various hemodynamic monitoring systems. The first clinical cases with the device have taken place at various U.S. and European sites. Commercial launch of the PrimeWire PRESTIGE is expected in June 2010.
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that Jean-Jacques Bienaime, Chief Executive Officer of BioMarin, will present a company update at the Citi Global Healthcare Conference in New York City on Wednesday, May 26, 2010 at 11:30 a.m. ET.
Bristol-Myers Squibb Company (NYSE: BMY) will present at the Citi Global Health Care Conference on Wednesday, May 26, 2010, in New York City.
Cerus Corporation (NASDAQ:CERS) announced today that William "Obi" Greenman has been promoted to chief business officer. This position capitalizes on his demonstrated leadership in achieving business goals for INTERCEPT Blood System and guiding Cerus' corporate strategy.
China Ruitai International Holdings Co., Ltd. (OTC Bulletin Board: CRUI), a manufacturer and distributor of cellulose ether additives for use in the production of pharmaceuticals, construction materials, PVC products, foods and beverages and cosmetics, today announced financial results for its first quarter ended March 31, 2010.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it will hold its Annual Meeting of Stockholders on Thursday, May 20, 2010 beginning at 10:00 am Eastern Time at the Willard InterContinental Washington, 1401 Pennsylvania Avenue NW, Washington, DC 20004.
NMT Medical, Inc. (NASDAQ: NMTI) announced today that it has appointed Paul H. Kramer, MD, 59, to its Board of Directors. With his appointment, NMT is increasing the number of seats on its Board to eight.
PharmaGap Inc. (OTCBB:PHRGF) today released initial testing results for PharmaGap's cancer drug GAP-107B8.
Rite Aid Corporation (NYSE: RAD) announced today that John Standley, president and chief operating officer, Frank Vitrano, chief financial and chief administrative officer, and Matt Schroeder, group vice president, strategy, investor relations and treasurer, will address the Citi Food & Drug Retail Conference on May 25, 2010 in New York City. Rite Aid's presentation is scheduled for approximately 1:45 p.m. EDT.
Senomyx, Inc. (NASDAQ: SNMX), a leading company focused on using proprietary taste receptor technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that Sharon Wicker, the Company's Senior Vice President and Chief Commercial Development Officer, and Gwen Rosenberg, Vice President, Investor Relations and Corporate Communications, will present a corporate overview on Wednesday, May 26, 2010 at 10:30 a.m. Eastern Time (7:30 a.m. Pacific Time) during the 2010 Janney Consumer Conference.
SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced that its SurModics Pharmaceuticals facilities in Birmingham, Alabama have been certified by Det Norske Veritas (DNV) Certification, Inc. as compliant to the Quality Management System Standards ISO (International Standards Organization) 9001:2008 and ISO 13485:2003.
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