TMCnet News
Other News To Note(BioWorld Today Via Acquire Media NewsEdge) , of Hopkinton, Mass., said that Cethrin has been granted designation as an orphan medicinal product for the treatment of traumatic spinal cord injury by the European Commission. The EU's decision was adopted following the favorable opinion issued by the European Medicine Agency Committee of Orphan Medicinal Products. The designation was granted to Triskel EU Services, Alseres' representative in the EU. ? Amsterdam Molecular Therapeutics BV, of Amsterdam, the Netherlands, obtained a license from Amgen Inc., of Thousand Oaks Calif., to use its GDNF gene for the development of a gene therapy treatment for Parkinson's disease. AMT said its gene-delivery platform potentially may provide a solution for delivering GDNF to the brain. The GDNF gene contains the information for a protein necessary for the development and survival of nerve cells. ? Biogen Idec Inc., of Cambridge, Mass., said the FDA granted fast-track status to BG-12 (dimethyl fumarate), an oral therapy for multiple sclerosis currently in the final stages of development. The FDA's fast-track programs are designed to expedite the review of new drugs intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Although BG-12 currently is marketed for other uses, it is not approved for use in patients with MS. ? Crucell NV, of Leiden, the Netherlands, said it has signed an exclusive commercial license agreement with Talecris Biotherapeutics Inc., of Research Triangle Park, N.C., for an undisclosed and specific protein to be produced using the PER.C6 cell line. Under the deal, Crucell will receive an up-front payment of $2.5 million following the execution of the agreement and will be eligible for milestone payments of about $30 million across multiple indications. Further financial details of the agreement were not disclosed. ? Dynavax Technologies Corp., of Berkeley, Calif., said in an 8-K filing that it submitted a response to the FDA's request for information regarding the clinical hold on two investigational new drug applications for Heplisav, a hepatitis B virus vaccine in development with partner Merck & Co. Inc., of Whitehouse Station, N.J. The clinical hold was placed on Heplisav in March, after a patient in the study began showing symptoms of vasculitis, also known as Wegener's granulomatosis. Dynavax's response contained a review of clinical and preclinical safety data, including data from a 2,427-patient Phase III trial that recently met its primary endpoint. The company said one patient tested positive for cytoplasmic-staining antineutrophil cytoplasmic antibody associated with vasculitis two months after the second Heplisav dose, and one patient in the control group receiving Engerix-B (GlaxoSmithKline plc) developed systemic vasculitis associated with perinuclear-staining antineutrophil cytoplasmic antibody four months after the second dose of Engerix-B. The FDA will evaluate the company's response and determine whether the data provided are satisfactory to allow the clinical program to continue. Heplisav is an immunostimulatory sequence that targets Toll-like receptor 9 with hepatitis B surface antigen. Shares of Dynavax (NASDAQ:DVAX) lost 2 cents, to close Thursday at $1.13. (See BioWorld Today, March 19, 2008, and Aug. 7, 2008.) ? Flamel Technologies SA, of Lyon, France, said it will receive $500,000 from Wyeth Pharmaceuticals, of Madison, N.J., under a 2007 license agreement for the development of a marketed protein to be delivered using Flamel's Medusa technology. Flamel said it also is receiving additional revenues from Wyeth for work being conducted on the development of the Medusa-enabled formulation of the protein. ? Neose Technologies Inc., of Horsham, Pa., said it agreed to sell its assets to its partners Novo Nordisk AS, of Bagsvaerd, Denmark and BioGeneriX AG, of Mannheim, Germany, in an all-cash deal for $43 million. Certain intellectual property rights, including those related to producing glycolipids, have been retained by Neose for future disposition. The asset sales, subject to approval by Neose stockholders, are the initial step in a contemplated liquidation of the company. The preliminary estimate of aggregate distribution amounts represents 27 cents to 45 cents per share of common stock. The closing price of Neose's common stock on Sept. 17 was 23 cents per share. Morgan Lewis acted as special transaction counsel, and RBC Capital Markets acted as exclusive financial advisor to Neose in the transactions. ? Oncothyreon Inc., of Seattle, was notified by Nasdaq that it did not comply with the requirements for continued listing on the Nasdaq Global Market because it did not meet the rules specifying, among other things, that the market value of its common stock be at least $50 million. The company had 30 days to regain compliance but was notified that it has not. ? Rosetta Genomics Ltd., of Rehovot, Israel, said an in vitro study published online in Biochemical and Biophysical Research Communications showed that over-expression of the microRNA product miR-451 inhibited the growth of glioblastoma and increased the efficacy of Gleevec (imatinib mesylate, Novartis AG) in the indication. Rosetta's first microRNA-based cancer diagnostics are expected to launch later this year. ? SIGA Technologies Inc., of New York, said it received an additional $20 million from the National Institute of Allergy and Infectious Disease (NIAID) to accelerate the development of smallpox antiviral ST-246. The funding comes from the Biomedical Advance Research and Development Authority (BARDA) to support biodefense products such as ST-246, and the recent award will be supplemental to SIGA's existing $16.5 million contract. It will be used for process development related to large-scale manufacturing and packaging of the drug and commercial-scale validation. Earlier this month, SIGA was awarded a $55 million contract from NIAID and BARDA to develop a parenteral formulation of ST-246 and to advance the drug in prophylactic use against smallpox. (See BioWorld Today, Sept. 4, 2008.) ? SurModics Inc., of Eden Prairie, Minn., said Merck & Co. Inc., of Whitehouse Station, N.J., is discontinuing its 2007 license and research collaboration agreement. Merck's decision, which triggered an additional $9 million payment to SurModics, was made following a strategic review of its business and product development portfolio and was not based on any concerns about the safety or efficacy of I-vation TA, the I-vation platform or any other SurModics sustained-drug delivery systems, SurModics stated. ? Tengion Inc., of East Norriton, Pa., said a preclinical study of its Neo-Bladder augment found that the product regained native bladder histology by three months, regained baseline capacity at three to six months, regained baseline compliance by 12 to 24 months, and adapted in size and function as the animal grew. The autologous replacement organ technology is in Phase II trials. The data were published in the journal Regenerative Medicine. ? ? Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |