(BioWorld Today Via Acquire Media NewsEdge) , of Santa Clara, Calif., said the FDA granted regulatory clearance to its GCS3000Dx platform for in vitro gene expression diagnostic testing. That microarray system, cleared along with the Pathwork Tissue of Origin Test from Sunnyvale, Calif.-based Pathwork Diagnostics Inc., is designed to analyze a tumor's gene expression profile to aid in diagnosing the source of hard-to-identify tumors.

? Basilea Pharmaceutica Ltd., of Basel, Switzerland, said European regulators recommended approval of Toctino (alitretinoin) as an oral therapy for severe refractory chronic hand eczema for use in adults who are unresponsive to corticosteroids. If approved, the drug will be the first authorized treatment for the disease. Applications for the product in severe chronic refractory hand eczema also are under regulatory review in Canada and in Switzerland.

? BioCancell Therapeutics Inc., of Jerusalem, closed a previously announced $2.5 million financing agreement with Tikcro Technologies Ltd., of Tel Aviv, Israel. The money is part of a $3.7 million private financing to support BioCancell's cancer clinical trials.

? Enzon Pharmaceuticals Inc., of Bridgewater, Pa., said that it filed a Form 10 Registration Statement with the U.S. Securities and Exchange Commission related to its previously announced plan to spin off its biotechnology business to Enzon's shareholders. In May, Enzon announced its plan to spin off its biotechnology business, named Evivrus Inc., to create a separate, publicly traded, biotechnology company. Evivrus will concentrate on the discovery and development of cancer medicines.

? Invitrogen Corp., of Carlsbad, Calif., licensed an engineered stem cell line used to study neurodegenerative disease from the Buck Institute for Age Research. Financial terms were not disclosed.

? Lux Biosciences Inc., of Jersey City, N.J., reported preclinical data demonstrating the safety and pharmacokinetics of LX214 as a potential once-daily topical treatment for chronic inflammatory diseases of the eye. Data, presented at the ARVO Summer Eye Research Conference in Monterey, Calif., showed that concentrations of the drug established therapeutic levels in tear fluid and most ocular tissues after single or multiple topical applications and there was minimal distribution of LX214 to the nontreated eye. LX214 is a micellar formulation of voclosporin, a next-generation calcineurin inhibitor licensed in 2006 from Isotechnika Inc., of Edmonton, Alberta. Lux is developing the product for dry eye syndrome, blepharitis and atopic keratoconjunctivitis.

? MediGene AG, of Martinsried, Germany, said it has sold its European rights of rosacea drug Oracea to Galderma Pharma SA, of Lausanne, Switzerland. MediGene said it will receive successive milestone payments totaling ?32 million (US$49.9 million), including an up-front payment of ?8 million.

? Memory Pharmaceuticals Corp., of Montvale, N.J., presented preclinical data for MEM 68626, its lead 5-HT6 antagonist drug candidate, at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD) in Chicago. The results demonstrated that MEM 68626 is effective in models of cognition that are considered predictive of efficacy in Alzheimer's disease and mild cognitive impairment. In addition, the data suggested the potential for once-daily oral dosing with a favorable safety and toxicology profile.

? MitoSciences Inc., of Eugene, Ore., said it signed an agreement with UK-based Roche Pharma to generate mitochondrial toxicity profiles for more than 100 known kinase inhibitors. Under the terms, Roche will provide the compound library plus previously gathered data from in vivo and in vitro experiments, and MitoSciences will apply its MitoTox technology to provide in vitro data for a broad set of mitochondrial toxicity endpoints. MitoTox uses antibody-based assays for measuring the function, express and post-translational modification of mitochondrial enzymes in dosed cells. Terms of the deal were not disclosed.

? Orexo AB, of Stockholm, Sweden, and ProStrakan Group plc, of Galashiels, Scotland, said they have extended their existing European licensing agreement for Abstral (rapinyl) for breakthrough cancer pain to include North America. The North American partner change follows the decision by Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., to return all rights for the drug to Orexo. Endo invested about $40 million in the development of Abstral, and Orexo has received an additional $26.9 million in licensing payments. Endo will finalize and finance the current Phase III studies of the drug, which are expected to end in December. Abstral received a positive opinion last month from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending approval. Under the terms of the new agreement for North America, ProStrakan will pay up-front and certain regulatory and sales milestone payments totaling $29 million, including a $2 million signing fee.

? PharmAthene Inc., of Annapolis, Md., said it submitted a response to a request for proposals for an anthrax recombinant protective antigen vaccine for the strategic national stockpile. The Department of Health and Human Services' RFP outlined a requirement to procure 25 million doses. PharmAthene is developing SparVax, an rPA anthrax vaccine consisting of rPA adsorbed into Alhydrogen and packaged as a liquid-filled syringe for intramuscular injection. The product has shown promising efficacy in preclinical trials and has been tested in Phase I and Phase II studies involving more than 700 healthy volunteers.

? Regenerx Biopharmaceuticals Inc., of Bethesda, Md., said it was awarded an additional $136,245 from the FDA's Office of Orphan Products Development for continued work on RGN-137, a thymosin beta 4 peptide, in epidermolysis bullosa, a rare skin blistering disorder. The drug is in a Phase II trial, which Regenerx expects to complete in 2009.

? Sequenom Inc., of San Diego, expanded its global alliance with SensiGen LLC, of Ann Arbor, Mich., covering SensiGen's molecular diagnostics using Sequenom's platform technology and reagents. Financial terms were not disclosed, but the agreement provides Sequenom with the future right to a minority equity interest in SensiGen.

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