|Health Canada asks Osiris for more info. Apricus receives Japanese patent. After the bell: GE Healthcare gets FDA nod|
|By Mary Davila|
|Friday, 14 January 2011 19:53|
Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced today that Health Canada has requested additional information wth regard to the company's application for Prochymal, a stem cell therapy, for the treatment of graft vs. host disease (GvHD), a side effect of organ or bone marrow transplants. Health Canada said the application in its current form is not in full compliance with the current Canadian Food and Drug Regulations. Osiris has 90 days to answer certain questions raised during the review. The company said that it intends to fully respond to these questions within that time frame.
"We thank the professionals at Health Canada for their rapid and thoughtful consideration of this important application," said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. "We intend to work with Health Canada to expeditiously provide them the additional information necessary to complete the application and make this important therapy available to patients in need."
Osiris is developing Prochymal through a partnership with Genzyme Corp. Shares of Osiris rose 36 cents or 5% to $7.42.
Apricus Biosciences, Inc., (Nasdaq:APRI) today announced that the Japanese Patent Office recently issued a Decision to Grant a Patent for the Company's development of a topical cream that utilizes vasoactive prostaglandin E to treat premature ejaculation ("PE"). This patent, entitled, "Compositions and Methods for the Treatment of Premature Ejaculation", when issued, will provide Japanese patent protection until March 2024. The patent is one in a series of issued patents and pending applications that Apricus Bio owns in the male sexual dysfunction field utilizing its proprietary NexACT technology, which includes its Vitaros product to treat erectile dysfunction ("ED"), among others in research and development.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are very pleased with this patent allowance in Japan for the use of vasoactive prostaglandin E to treat PE, which includes the same pharmaceutical composition as Vitaros, combined with a local anesthetic. While we are aggressively pursuing licensing applications for Vitaros, we are also developing related products utilizing our NexACT technology that may add to the value of our existing portfolio of drugs to treat sexual dysfunction. We are very excited about the issuance of this newest patent and we are actively seeking patent protection for this PE application in the U.S. and in other countries."
On heavy volume, shares gained 13 cents or 3.4%, closing at $3.95.
ICON plc, (NASDAQ:ICLR)(ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the expansion of its Late Phase and Outcomes Research services through the acquisition of Oxford Outcomes, a leading international health outcomes consultancy. Elizabeth Thiele, formerly ICON’s Executive Vice President of Business Development, has been appointed President of this specialised service unit.
Headquartered in Oxford, UK, and with offices in the USA and Canada, Oxford Outcomes provides specialist services in the areas of patient reported outcomes (PRO), health economics, epidemiology and translation and linguistic validation.
Peter Gray, CEO at ICON plc, commented, "The biopharmaceutical industry and regulators are more than ever before using post-marketing studies to demonstrate efficacy and safety, as well as demonstrating the economic value of products. Oxford Outcomes has grown to become a leader in its field and brings to ICON a wealth of expertise in the fields of health economics, outcomes research and epidemiology and a strong reputation for excellent client service."
Amarillo Biosciences, Inc. (ABI) (OTC.BB:AMAR) and Oasis Diagnostics Corporation today announced that they have entered into an agreement under which Oasis will exclusively market Maxisal, ABI's dietary supplement for enhancement of salivary function, promotion of oral comfort and relief of dry mouth, in North, Central and South America, China and Taiwan.
After the bell, GE Healthcare, a unit of General Electric Company (NYSE:GE) announced that the US Food and Drug Administration has approved DaTscan, a radiopharmaceutical agent intended for use with single photon emission computed tomography (SPECT) imaging, for the detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes (PS). The first FDA-approved diagnostic imaging agent to help physicians evaluate neurodegenerative movement disorders, such as idiopathic (of unknown cause) Parkinson's disease (PD), DaTscan may be used as an adjunct to other diagnostic evaluations to help differentiate essential tremor (an involuntary shaking of the hands, head, and face) from tremor due to PS. DaTscan cannot differentiate between the different types of PS.