TMCnet News
Other News To Note(BioWorld Today Via Acquire Media NewsEdge) , of Buffalo Grove, Ill., said it has received approval for its abbreviated new drug applications for dexamethasone sodium phosphate injection 4 mg (base)/mL in 1mL, 5 mL and 30 mL vials, and dexamethasone sodium phosphate injection 10 mg (base)/mL in 10 mL vials. Dexamethasone sodium phosphate injection is indicated to treat various conditions, including endocrine disorders, arthritis, blood disorders, dermatologic diseases, severe allergic reactions, eye diseases and certain cancers, gastrointestinal diseases and respiratory diseases. Recent IMS data estimated an annual market size for dexamethasone of about $28 million. ? Alpharma Inc., of Bridgewater, N.J., said the FDA accepted and designated for priority review its new drug application for pain product Embeda (morphine sulfate-extended release with sequestered naltrexone hydrochloride) capsules. Priority status provides for a review period of six months from the June 30 submission date. Embeda was developed using Alpharma's technology, which is designed to combine an extended-release opioid with sequestered naltrexone for an abuse-resistant product. ? Anavex Life Sciences Corp., of Geneva, said it completed preclinical studies of anavex 2-73, a sigma-1 receptor agonist in development for Alzheimer's disease, in which it demonstrated significant neuroprotective, anti-amnesic and anticonvulsive properties in vitro and in vivo in mice. It also exhibited a good safety profile, as well as therapeutic activity at very low doses. Anavex expects to prepare an investigational new drug application to start human testing. ? Arpida Ltd., of Reinach, Switzerland, filed a new drug submission seeking Canadian approval of intravenous iclaprim for complicated skin and skin structure infections. Approval applications for the antibiotic have also been filed in the U.S. and Europe. ? Avantogen Ltd., of Brisbane, Australia, and Hawaii Biotech Inc., of Aiea, Hawaii, said the U.S. Walter Reed Army Institute of Research will include their recombinant DNA-based Dengue vaccine candidate in a broader clinical trial program. The two companies combined their vaccine programs in 2006 and initiated a Phase I study with their West Nile vaccine candidate earlier this year. ? Burnham Institute for Medical Research, of La Jolla, Calif., received a six-year, $97.9 million National Institutes of Health grant to establish one of four small-molecule screening centers in the Molecular Libraries Probe Production Centers Network. The Orlando, Fla.-based facility will open in 2009 and will use robotic systems for ultra-high-throughput screening of the NIH's library of 300,000 small molecules. ? Debiopharm Group, of Lausanne, Switzerland, said that it has signed a research project with the Ecole Polytechnique Federale de Lausanne, aimed at the identification of small molecules and peptides that interfere with pathways controlling cell fate specification. That project, Debio 0826, could lead to the development of potential therapeutic compounds and to the identification of new targets to fight cancer stem cells, the company said. ? Diamyd Medical AB, of Stockholm, Sweden, said that its nerve targeting drug delivery system expressing enkephalin effectively relieved pain due to diabetes in animal models. The finding, published in Journal of Neuroscience, suggested that the NTDDS platform allows focal delivery of the human enkephalin gene directly to nerves experiencing pain, according to the company. Diamyd's product NP2 (NTDDS expressing enkephalin), is currently in Phase I safety studies. ? DxS Ltd., of Manchester, UK, said it signed a nonexclusive global licensing agreement with Wellcome Trust. DxS will provide a research test for use in clinical trials to detect the presence of the V600E B-RAF mutation, which is found in melanomas, lung and thyroid cancers. Researchers will use the test to determine a patient's cancer mutation status, which may predict how they respond to cancer therapies. If clinical trials are successful, that could lead to a companion diagnostics to predict response for cancer therapies for skin, thyroid and large intestine cancers, the company said. Financial details were not disclosed. ? Evotec AG, of Hamburg, Germany, said that a third milestone has been achieved in its collaboration with Boehringer Ingelheim GmbH, of Mannheim, Germany. Under the terms of the drug discovery contract, Evotec will receive a milestone payment from Boehringer Ingelheim, which was granted for the selection of an advanced compound for profiling to enable the start of preclinical development. Further financial details of the payment were not disclosed. ? Idera Pharmaceuticals Inc., of Cambridge, Mass., said it will receive an undisclosed milestone payment from Novartis AG, of Basel, Switzerland, under the firms' partnership for Idera's QAX935, an agonist of toll-like receptor 9. The payment was triggered by the initiation of a Phase I clinical study by Novartis. ? Ikaria Holdings Inc., of Clinton, N.J., is acquiring North American rights to Lucassin (terlipressin) from Lebanon, N.J.-based Orphan Therapeutics LLC. Financial terms were not disclosed. Orphan has initiated a rolling new drug application for Lucassin, a synthetic vasopressin analogue, in hepatorenal syndrome Type 1, and the drug has been granted orphan drug and fast-track status in that indication. Under its agreement with Ikaria, Orphan will transfer North American rights following marketing approval. Ikaria then will be responsible for postmarket development and commercialization. ? InterMune Inc., of Brisbane, Calif., said it has earned a $15 million development milestone under its development collaboration with F. Hoffmann-LaRoche AG, of Basel, Switzerland, for ITMN-191 (also known by Roche as R7227), an NS3 protease inhibitor compound currently in a Phase Ib trial in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) as a treatment for the hepatitis C virus. Under the terms of a 2006 deal, the clinical program for ITMN-191 is being transitioned to Roche, which starting in Phase II will have primary responsibility for completing the global development and registration program. ? OncoGenex Pharmaceuticals Inc., of Bothell, Wash., said that it has granted to Eagle Pharmaceuticals Inc., of Vancouver, Canada, the exclusive worldwide rights to develop and commercialize tocosol paclitaxel. Under the terms of the agreement, OncoGenex is entitled to receive royalty payments from future sales of the product and a percentage of sublicensing royalty and milestone payments received by Eagle. All development expenses are the sole responsibility of Eagle Pharmaceuticals. No up-front payments or milestone payments were included in the transaction, and no further terms have been disclosed. ? Pain Therapeutics Inc., of San Mateo, Calif. said Tuesday it has received $20 million from partner King Pharmaceuticals Inc., of Bristol, Tenn., in milestone payments. Pain Therapeutics said $15 million was paid by King after the FDA accepted the new drug application for Remoxy, a long-acting oral formulation of the opioid oxycodone, to treat moderate to severe chronic pain. Pain and King, which entered into a $400 million deal in 2005, submitted the application for Remoxy in June. (See BioWorld Today, June 11, 2008.) ? QLT Inc., of Vancouver, British Columbia, said it closed an agreement to sell the land and building comprising its corporate headquarters and the adjacent undeveloped parcel of land to Discovery Parks Holdings Ltd. for C$65.5 million (US$61.4 million). In conjunction with the sale, QLT has entered into a five-year lease with Discovery Parks for about 30 percent of the facility and will provide a two-year 6.5 percent interest-only second mortgage vendor financing for C$12 million. ? Stem Cell Sciences plc, of Cambridge, UK, said it achieved germ-line transmission from embryonic stem cells in rats. The achievement was based on technology licensed from Edinburgh University, and the company plans to sublicense the cells to others for use in drug discovery applications, such as the creation of knockout and knock-in rat models. ? ZymoGenetics Inc., of Seattle, will receive a $5 million milestone payment triggered by partner Leverkusen, Germany-based Bayer AG's submission of a marketing authorization application seeking European approval of Recothrom Thrombin (Recombinant Thrombin) as a topical aid to control surgical bleeding. The product received FDA approval in January, and ZymoGenetics posted second-quarter revenues of $1.4 million from its U.S. sales efforts. (See BioWorld Today, Jan. 18, 2008.) ? ? Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |