• ABR-Affinity BioReagents, of Golden, Colo., said it entered distribution agreements on research antibodies with Genesis Biotech Inc. and Good Biotech Corp., both of Taiwan. Genesis Biotech manufactures antibodies focusing on gene function and discovery. Good Biotech manufactures antibodies focused on disease research. ABR-Affinity will distribute the products in the U.S. Terms of the deals were not disclosed.

• Adolor Corp., of Exton, Pa., said the FDA notified it and partner GlaxoSmithKline plc, of London, that the agency needs additional time to complete its review for releasing the clinical hold on alvimopan (Entereg). As a result, the clinical hold for all alvimopan investigational new drug applications remains in effect. The FDA did not indicate when its review might be completed. The hold was placed due to concerns about serious cardiovascular events in trials in opioid-induced constipation and bowel dysfunction. A new drug application for the management of postoperative ileus remains on track, with an FDA Prescription Drug User Fee Act goal date of Feb. 10. (See BioWorld Today, April 11, 2007, and Aug. 29, 2007.)

• AlphaRx Inc., of Markham, Ontario, said it is advancing to preclinical development ARX828, an orally administered inhibitor of iNOS, or inducible nitric oxide synthase. It plans to file an investigational new drug application in 2008. The company has initiated two pivotal animal studies for ARX828. The plan is to develop ARX828 for the treatment of rheumatoid arthritis and inflammatory bowel disease.

• Encysive Pharmaceuticals Inc., of Houston, announced the commercial availability of Thelin (sitaxsentan) 100-mg tablets in Spain for the treatment of pulmonary arterial hypertension. Encysive received European Union marketing authorization for Thelin in August 2006. The selective endothelin A receptor antagonist will be sold in Spain by a marketing partner. Encysive said Thelin will be launched in successive EU member states as local government reimbursement approvals are obtained.

• Medisyn Technologies Inc., of Minneapolis, and the Mount Sinai School of Medicine in New York entered a collaboration to develop beta-amyloid-lowering drugs as a treatment for Alzheimer's disease. MSSM has research data from testing early stage lead compounds. They will use Medisyn's molecular topology Forward Engineering platform to build a pipeline of drug candidates. The goal is to complete in vivo efficacy validation of the drug candidates by the end of 2007. Validated and characterized lead compounds would be out-licensed for further clinical development. Commercialization rights will be shared between MSSM and Medisyn.

• Mutabilis SA, of Paris, and Oroxcell, a French contract research organization, entered a second research collaboration. Oroxcell will conduct certain preclinical work on an anti-Staphylococcus preclinical candidate from Mutabilis, which is developing small-molecule inhibitors of antibacterial targets. Terms of the deal were not disclosed.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the amendment to its new drug application for ISO-Vorin (levofolinic acid, or LFA) for injection has been accepted by the FDA. It said the FDA targeted Jan. 11 as its action date regarding the approval of the NDA, which is seeking approval of the product for treating osteogenic sarcoma. ISO-Vorin is the pure active isomer of calcium leucovorin, a chemotherapy agent. The FDA's Oncology Drug Advisory Committee already recommended ISO-Vorin for approval, based on clinical data demonstrating the efficacy, safety and bioequivalency in comparison to the racemic leucovorin form, Spectrum said. The amendment to the NDA provided additional manufacturing information and stability data.

• Virium Pharmaceuticals Inc., of Princeton, N.J., licensed rights to 4'-Thio-Ara-C, also known as SR9025, from Southern Research Institute in Birmingham, Ala., to develop against cancer. The compound, registered to Virium as VP700, is a third-generation nucleoside analogue and has completed two Phase I trials. Under the terms, Southern Research will receive cash and stock in Virium. John Secrist, president and CEO of Southern Research, will join Virium's scientific advisory board, and Nancy Gray, vice president of corporate development at Southern Research, was named to the company's board.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., said a paper published in Leukemia Research reported on the results of an in vitro study conducted by Xanthus in multidrug-resistant leukemia cell lines. In the study, the cytotoxic effect of Xanafide (amonafide malate) was found to be unaffected by the overexpression of P-glycoprotein in acute myeloid leukemia cell lines and that Xanafide was neither a substrate nor an inhibitor of Pgp. The company said it believes the finding supports the positive levels of complete remissions observed with Xanafide, an ATP-independent topoisomerase II inhibitor, in Phase I and II trials in AML.