|RxNews Recap for Friday 02-05-10. Optimer (OPTR) gains on positive Phase 3 results|
|By Mary Davila|
|Friday, 05 February 2010 18:50|
Below is a list of the companies that made news in the healthcare sector on Friday, February 05, 2010.
Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI).
In the late-stage study, fidaxomicin, an anti-biotic pill, proved to be as efficacious as existing standard of care Vancocin in treating clostridium difficile infection -- a bacterial infection in the gut.
This study was conducted in approximately 100 clinical sites throughout North America and Europe. Optimer plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.
The San Diego based company focuses on discovering, developing, and commercializing anti-infective products that treat gastrointestinal infections and related diseases
Optimer shares gained 68 cents, or 5.73 percent, to close the day at $12.54. Earlier in the day, shares traded as high as $13.70.
After the bell today:
Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced after the bell through its wholly owned subsidiary, Strativa Pharmaceuticals, that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.
Due to an agency-wide restriction on foreign travel in India, the FDA has been unable to perform an inspection of the clinical and analytical sites for a bioequivalence study, and therefore, cannot approve the application at this time. The FDA advised that they will schedule and perform an inspection of these sites as soon as possible. Strativa will continue to work with the FDA on completing these site inspections and finalization of product labeling. No issues related to the study data or film product were identified. Shares of Par were off 2.27% in the after hours market.
In news from earlier in the day:
Alkermes Inc.(Nasdaq: ALKS) gained 6.27% today after Jeffries analyst issued an upgrade from Hold to Buy based on strong sales of its schizophrenia drug during the third quarter. Alkermes is an integrated biotechnology company, offering extended-release injectable, pulmonary, and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction, and diabetes. It primarily develops, manufactures, and commercializes VIVITROL, an extended-release Medisorb formulation of naltrexone for the treatment of alcohol dependence, as well as for the treatment of opioid dependence. The company also manufactures RISPERDAL CONSTA, a formulation of risperidone for the treatment of schizophrenia and bipolar disorder.
Amicus Therapeutics (Nasdaq: FOLD) announced today that its Board of Directors has elected John F. Crowley as Chairman of the Board in addition to his current role as Chief Executive Officer (CEO), effective immediately. Mr. Crowley will succeed Donald J. Hayden, Jr., who will become the Lead Independent Director of the Board. Amicus Therapeutics is developing orally-administered, small molecule drugs called pharmacological chaperones, a novel, first-in-class approach to treating a broad range of diseases including lysosomal storage disorders and diseases of neurodegeneration. Amicus' lead program is in Phase 3 for the treatment of Fabry disease.
Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that Barry D. Quart, Pharm.D., president and chief executive officer, will present at the 12th Annual BIO CEO and Investor Conference.
AVI BioPharma Inc (Nasdaq:AVII) announced Friday that its experimental drug for the treatment of genetic muscle-wasting disease received an orphan drug status from the European Medicines Agency (EMEA).
The designation may provide AVI BioPharma up to 10-year market exclusivity in Europe, following marketing approval, for its AVI-5038 product.
Duchenne muscular dystrophy (DMD) is a disease characterised by progressive muscle degeneration, affecting young children, almost exclusively boys. It leads to paralysis and death in young adulthood.
In 2008, AVI BioPharma received an orphan drug status from the EMEA for another drug, AVI-4658, to treat DMD.
Products granted an orphan drug designation by the EMEA are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the EU.
Shares closed the day unchanged at $1.42.
BioTime, Inc.(NYSE Amex:BTIM) today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.“The U.S. Army has deployed Hextend for initial resuscitation of battlefield casualties because less Hextend is required compared to commonly used saline solution to achieve the same plasma volume expansion effect. This offers a major logistic advantage for a combat medic who has to carry all his supplies in his backpack,” said Dr. Proctor. “Our team was one of the first to evaluate the potential use of Hextend as a resuscitation fluid in the laboratory but no one had evaluated the safety and efficacy specifically in trauma patients even though there had been several other studies by other investigators in various other types of surgical patients.” Dr. Proctor cautioned that their “...study design has several limitations, but that the results are encouraging and warrant a randomized controlled clinical trial.” He also stated that it is “...extremely rewarding to provide solid evidence that our heroes in Iraq and Afghanistan are receiving state of the art fluid resuscitation on the battlefield.”
Pfizer Inc. (NYSE: PFE) and DxS (a wholly owned subsidiary of QIAGEN N.V.) (NASDAQ: QGEN); (Frankfurt, Prime Standard: QIA) today announced that they have entered into an agreement to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM). Financial terms of the diagnostic agreement have not been disclosed. “We look forward to collaborating with QIAGEN's DxS unit in the development of this important diagnostic tool that could potentially help physicians better define the most appropriate treatment for patients who suffer from glioblastoma multiforme,” said Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit.
Regenerex Biopharmaceutical, Inc. (Amex:RGN) announced today that a research team in Washington, D.C. has found that dystrophin-deficient Mdx mice, treated twice a week for six months with Tβ4, showed a significant increase in skeletal muscle regenerating fibers compared to untreated mice. No effects related to muscle function or fibrosis and no adverse reactions were observed in the mice. Mdx mice are used as models for Duchenne muscular dystrophy to evaluate potential therapeutic compounds. According to the research team, “In exercised dystrophin deficient mice, chronic administration of Tβ4 increased the number of regenerating fibers in skeletal muscle and could have a potential role in the treatment of skeletal muscle disease in Duchenne muscular dystrophy.” Because Tβ4 stimulates cell migration and anti-apoptosis pathways in skeletal muscle cultures, these data further suggest a role for Tβ4 in muscle degenerative diseases and injury.
“This study is particularly important as it provides the first direct correlation of gene expression data with in vivo administration and histological localization of Tβ4 in muscle tissue,” stated Dr. Allan L. Goldstein, Professor of Biochemistry and Molecular Biology at the George Washington University Medical Center, Washington, DC, and RegeneRx’s chief scientific advisor. Shares of Regenerex closed up more than 11% to 59 cents.
Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI), a commercial-stage biotechnology company with a focus in oncology, announced today that Rajesh C. Shrotriya MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, will provide an overview of the Company’s business strategy at the 2010 BIO CEO Investor Conference on Tuesday, February 9, 2010, at 11:30am Eastern Time.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.