|Aeterna Zentaris and Keryx rise on Orphan drug designation|
|By BioMedReports.com Staff|
|Wednesday, 14 July 2010 19:40|
Below is a list of the companies that made news in the healthcare sector on Wednesday, July 14, 2010.
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), has been granted orphan-drug designation by the U.S. Food and Drug Administration for perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral Akt inhibitor, for the treatment of neuroblastoma. Neuroblastoma is a cancer of the nervous system affecting mostly children and infants for which there are no FDA approved therapies. Keryx is Aeterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Æterna Zentaris has also out-licensed perifosine to Handok in South Korea, while retaining rights for the rest of the world.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "The orphan-drug designation in neuroblastoma is another important milestone in the development of perifosine as a novel approach to treating cancer patients, particularly in this area of unmet medical need. We are looking forward to perifosine's future development in neuroblastoma and in other indications with our partner Keryx."
Phase 1 data of perifosine in recurrent pediatric solid tumors, including neuroblastoma, were presented last month in the pediatric solid tumor poster discussion session held at the 46th Annual Meeting of the American Society of Clinical Oncology ("ASCO"). Investigators from the Memorial Sloan-Kettering Cancer Center concluded that perifosine was demonstrated to be safe and well tolerated in children with advanced solid tumors and that perifosine may have antitumor clinical activity as a single agent in neuroblastoma. Additionally, in a preclinical study recently published in the Journal of the National Cancer Institute, perifosine showed a statistically significant reduction in neuroblastoma cell survival, slowed or regressed tumor growth, and increased survival in mice bearing neuroblastoma tumors.
A decreased level of activated Akt was also observed in perifosine-treated neuroblastoma cells and xenograft tumors.
Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials in the United States for advanced colorectal cancer and multiple myeloma, under Special Protocol Assessment and Fast Track designation granted by the FDA for both indications. FDA has also granted perifosine orphan-drug designation for multiple myeloma and neuroblastoma. In Europe, the European Medicines Agency ("EMA") has issued positive Scientific Advice for perifosine in multiple myeloma and colorectal cancer, as well as positive opinion for Orphan Medicinal Product designation for perifosine in multiple myeloma.
Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.
A5 Laboratories Inc. (OTCBB:AFLB) is pleased to announce that it has reached an agreement to provide full CRO and development services to Neolabs of Concord, Ontario. Upon obtaining health Canada laboratory establishment licence the company will be providing raw material, finished product and stability services to Neolab.
Allscripts-Misys Healthcare Solutions, Inc. (Nasdaq: MDRX) ("Allscripts") today announced that a record date and a special meeting date have been established for Allscripts stockholders to consider and vote upon a proposal to approve the issuance of shares of Allscripts common stock to stockholders of Eclipsys Corporation (Nasdaq: ECLP) pursuant to the previously announced merger agreement with Eclipsys.
AmStem Corporation (OTCBB: AMST), a leading provider of biotherapeutic and cosmetic stem cell products, stem cell collection and storage expertise and access to nanotechnology vital to stem cell research, announced today positive early results from its preliminary consumer study of SteMixx™.
Beacon Enterprise Solutions Group, Inc. (OTCBB: BEAC) (www.askbeacon.com), an emerging global leader in the design, implementation and management of high perform nce Information Technology Systems (ITS) infrastructure solutions, today announces the execution of a new contract with an existing Beacon customer, a Fortune 100 pharmaceutical company with domestic and international locations.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria dete tion, and other innovative technologies, today announced the results of recent testing of the unique PVA film formulation produced by Lanzhou Sanhuan New Technology Development Ltd. of Ganzu, China.
Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, will report financial results for the second quarter of 2010 on Thursday, July 29, 2010.
Eclipsys Corporation (NASDAQ:ECLP), The Outcomes Company®, today announced its response to the Center for Medicare and Medicaid Services’(CMS) final rule on ‘meaningful use’ of an electronic health records (EHR). Countering opinions describing any criteria to include Computerized Provider Order Entry (CPOE) in 2011 as “too ambitious,” Eclipsys applauds CMS for coming forward to add electronic medication order entry as a requirement for achieving “meaningful use.”
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company's large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.
Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) will release its second quarter 2010 financial results on Wednesday, August 11, 2010, after the market closes.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has filed a lawsuit in U.S. District Court in New Jersey against Lupin Limited for infringement a ainst Gilead's patents for Ranexa® (ranolazine extended-release tablets).
Illumina, Inc. (NASDAQ:ILMN) today announced that it will issue results for second quarter 2010 following the close of market on Tuesday, July 27, 2010.
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.
Itronics Inc. (PINKSHEETS: ITROD) reported today that its wholly owned subsidiary, Itronics Metallurgical, Inc., has scheduled its Stage I silver refinery expansion for start up in August 2010.
Kendle (Nasdaq: KNDL) announced today it will release its second quarter 2010 financial results after the market closes on Wednesday, Aug. 4, 2010.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that KRX-0401 (perifosine) has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants for which there are no FDA approved therapies.
The Medicines Company (NASDAQ: MDCO) has scheduled its quarterly conference call for Wednesday, July 28, 2010 at 8:30 a.m. Eastern Time to discuss second quarter 2010 financial results and operational developments.
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nabumetone Tablets USP, 500 mg and 750 mg. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Nabumetone Tablets, a treatment for osteoarthritis and rheumatoid arthritis. The product will be distributed by Mylan Pharmaceuticals Inc.
Pall Corporation (NYSE:PLL) today announced that it has entered into a new $500 million five-year revolving credit facility.
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that it has initiated a second randomized Phase IIb non-small cell lung cancer (NSCLC) trial, this one in front-line patients.
Perrigo Company (Nasdaq: PRGO; TASE) announced its filing with the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Emulsion Foam, 0.05% and notified Stiefel Research
Radient Pharmaceuticals Corporation (NYSE Amex: RPC), a US-based pharmaceutical company, has announced the launch of its newly designed website located at www.radient-pharma.com and new corporate video featured onRPC's new corporate website and recently launched Onko-Sure™ product website located at www.onkosure.com.
Renhuang Pharmaceuticals, Inc. (NYSE Amex: CBP) ("Renhuang" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM"), today announced that Renhuang showcased its range of all-natural, plant-based Botanical, Traditional Chinese Medicines and Biopharmaceutical products at the 45th China National New and Special Drugs Fair 2010 (the "Drug Fair") from July 8th to July 10th.
Samsung Medical Center and the world's leading bio-pharmaceutical company Pfizer Inc. (NYSE:PFE) announced that they have formed a research partnership to jointly analyze tumors from Korean patients to generate gene expression profiles and that may ultimately direct therapies and enhance clinical outcomes in the patients with liver cancer.
SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, reports the European launch of the orthoPACE™ device intended for use in orthopedic, trauma and sports medicine indications following CE mark approval last month.
Simcere Pharmaceutical Group (NYSE:SCR) ("Simcere" or the "Company"), a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China, today announced that the annual general meeting of shareholders (the "Meeting") will be held on Wednesday, July 28, 2010 at 10 a.m. Beijing time, at No.699-18, Xuanwu Avenue, Xuanwu District, Nanjing, People's Republic of China.
Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded harmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that it has established a commercial team to promote Silenor® (doxepin) for the treatment of insomnia characterized by difficulties with sleep maintenance.
SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today that it will host a live webcast of its third quarter 2010 conference call on Wednesday, July 28, at 4:00 p.m. CT.
Talecris Biotherapeutics Holdings Corp. (Nasdaq: TLCR) today confirmed that it filed its premerger notification and report form with respect to its proposed merger with Grifols S.A. under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with the Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice on July 6, 2010.
The board of directors of Walgreen Co. (NYSE: WAG)(NASDAQ: WAG) today increased the quarterly dividend 27.3 percent to 17.5 cents per share from the previous rat of 13.75 cents per share.
Wright Medical Group, Inc. (NASDAQ: WMGI) today announced that it will host a conference call on Monday, August 2, 2010 at 3:30 p.m. Central Time to discuss the Company's operating results for its second quarter ended June 30, 2010. Operating results will be released at 3:00 p.m. Central Time that day.