Jazz rallies on FDA comments. ImmunoGen granted orphan status Print E-mail
By BioMedReports.com Staff   
Wednesday, 18 August 2010 20:06
Below is a list of the companies that made news in the healthcare sector on Wednesday, August 18, 2010.

Jazz Pharmaceuticals Inc. (Nasdaq:JAZZ) moved higher Wednesday after the FDA said that its drug candidate for fibromyalgia appears to be effective in treating the chronic pain disorder. The drug is set to be reviewed this Friday, August 20th by an FDA review panel. After closing Tuesday's trading at $10.25, shares shot up as high as $11.90 before pulling back and settling the day at $10.61, up 36 cents or 3.51%. Shares continued higher in the after hours market.

ImmunoGen, Inc (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, today announced that the US Food and Drug Administration has granted orphan drug designation to its lorvotuzumab mertansine (formerly IMGN901) product candidate when used for the treatment of small-cell lung cancer (SCLC). Through a separate process, ImmunoGen has received a positive opinion for lorvotuzumab mertansine as an orphan medicinal product for the treatment of SCLC from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) and is awaiting final designation from the European Commission. The compound previously was granted orphan drug designation for the treatment of Merkel cell carcinoma in both the US and European Union (EU).

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced today that the application has been granted a priority review designation by the FDA.

Hemispherx Biopharma, Inc. (AMEX:HEB) today announced that its six-year litigation battle with the South African investment conglomerate JCI Ltd., traded on the Johannesburg Stock Exchange, ended in victory August 11, 2010, with the entry of a $188 million judgment in Hemispherx's favor and against Johannesburg Consolidated Investments (JCI) and former JCI officers R.B. Kebble and H.C. Buitendag. Kebble and Buitendag used JCI Ltd. to pull off what South African authorities have called the largest financial fraud in that country's history, engaging in numerous acts of securities fraud. As stated in Hemispherx's complaint, this included the illegal attempt to take over and pillage Hemispherx.

Immunomedics, Inc. (Nasdaq:IMMU) and GE Healthcare, a business unit of General Electric Company (NYSE:GE), announced today that they have entered into a license and collaboration agreement for the evaluation of labeling technologies based on Immunomedics' patented F-18 peptide labeling method. Terms of the agreement were not disclosed, but GE Healthcare will fund all costs related to this collaboration.

Intellect Neurosciences, Inc. (OTCBB:ILNS) a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has locked the database of the Company's Phase 1b clinical trial for its lead Alzheimer's candidate, OXIGON(TM) (OX1). The Company tested OX1 for safety and tolerability in 36 healthy elderly volunteers aged 60 or more during 14 days of repeated dosing in a double blind, randomized, placebo-controlled, multiple escalating dose study. Locking of a database is done after review, query resolution, and a determination that the database is ready for analysis. Intellect is the sponsor of this trial, which was conducted by Kendle, a global clinical research organization, through the Kendle Clinical Pharmacology Unit located in Utrecht, The Netherlands. As the sponsor, Intellect takes responsibility for the initiation and management of the clinical trial.

Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company has requested a Type B Meeting in order to review the Company’s Phase III protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

Revolutions Medical Corporation (OTCBB:RMCP), announces detailed studies to further expand the value of its proprietary MRI imaging tools. Tom O'Brien, President of Revolutions Medical and an early pioneer in the launch of Magnetic Resonance with Johnson & Johnson's Technicare Corporation states, "30 years ago the founders and Nobel Prize winners envisioned applications of Magnetic Resonance in color where the diagnosis could be made and success of treatment could be monitored. With these first application studies we will hopefully realize that dream of the MRI founders. Future applications may be possible where we can follow hemorrhage history through clear indications as well as assess effectiveness of cancer treatments more easily through changes in color."

XOMA Ltd. (Nasdaq:XOMAD), a leader in the discovery and development of therapeutic antibodies, announced today that it has sold its royalty interest in CIMZIA(R) (certolizumab pegol) marketed by UCB S.A. for $4 million to an undisclosed buyer. The manufacture of CIMZIA is covered by a license to XOMA's Bacterial Cell Expression technology. The licensed U.S. patents will expire in 2014. CIMZIA is a pegylated antibody fragment that targets tumor necrosis factor alpha. It is approved in the U.S. to treat Crohn's disease and rheumatoid arthritis.

"The sale of our royalty interest in CIMZIA provides non-dilutive funding to support the development of XOMA 052 for Type 2 diabetes and other diseases and our preclinical programs," said Steven B. Engle, Chairman and CEO of XOMA.

Also Wednesday: 

AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer of advanced polymer materials for a broad range of medical devices, today announced financial results for its fiscal 2011 first quarter ended June 30, 2010.
Advaxis, Inc., (OTC:ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has completed the nine (9) doses to be administered to the three (3) vanguard patients in the low dose group of its phase II cervical dysplasia clinical trial study.
Agilent Technologies Inc. (NYSE:A) and the Agilent Foundation today announced that Dr. Thomas Hartung has received an Agilent Thought Leader Award in support of his research for the use of toxicity pathways to predict developmental neurotoxicity.
Axxess Pharma, Inc. (PINKSHEETS: AXXE), a pharmaceutical company specializing in the marketing and distribution of both prescription and non-prescription drugs, wishes to advise shareholders and other interested parties that Senior Management has become awareof an unauthorized press release being disseminated to the public by Mina Mar Marketing Group.
Biogen Idec (NASDAQ: BIIB) and Knopp Neurosciences today announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and potentially other indications.
Bohai Pharmaceuticals Group, Inc. (OTCBB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine in China, today announces the availability of a new online Investor Fact Sheet.
Celera Corporation (NASDAQ:CRA) today announced the publication of a review article on the KIF6 gene variant as a predictor of risk of coronary heart disease (CH ) and reduction of CHD events from statin therapy. 
Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI) announced today that the Company has signed an option with Regenevita, owner of the right to license Neo Natal Proenitor Cell Expansion Technology in Latin America. 
Martek Biosciences Corporation (Nasdaq:MATK) announced today that it intends to release the results of its third quarter of fiscal 2010 on Wednesday, September 1, 2010, at approximately 4:00 p.m. Eastern Time (ET).
Regenicin, Inc. (OTC Bulletin Board:WDSTD), a development stage biotechnology company, announced today that it has completed an initial $3.25 million funding in conjunction with its acquisition of a worldwide exclusive license to know-how technology controlled by Lonza Walkersville.
Sigma-Aldrich Corporation (Nasdaq:SIAL) is pleased to announce that Magnus Borg has been named Vice President and Chief Information Officer, effective August 16, 2010.
Smokefree Innotec, Inc. (Pink Sheets:SFIO) confirmed today the announcement by the Biotech company Cannabis Science (OTCBB:CBIS) regarding entering into a joint venture agreement to develop and market several high-tech smoke-free vaporized medical cannabis pharmaceutical products, as released by CBIS on August 13.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it has opened a Technology Center in Shanghai, building on its engineering and development capabilities to meet the specific needs of customers in China.
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.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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