• BioAlliance Pharma SA, of Paris, said that in vivo and in vitro results for its new drug candidate plasmid AMEP, which codes for an anti-invasive peptide, showed that the compound binds to cellular receptors, integrins, which are present on the endothelial cells of neovessels and on some tumoral cells. The in vitro research showed that AMEP inhibits both proliferation and invasion of endothelial cells that cause the formation of neovessels. It also inhibits the proliferation and migration of human melanoma cells. The in vivo research results were achieved with the AMEP plasmid on an invasive melanoma model using intratumoral electrotransfer. The effect of a single dose gives more than 80 percent inhibition of tumoral growth. With repeated doses, there is a 97 percent inhibition of tumoral growth and in 40 percent of cases complete and lasting regression of the tumors.
• BTG plc, of London, will receive $10 million from its licensee Tolerx Inc., of Cambridge, Mass., following the deal between Tolerx and London-based GlaxoSmithKline plc to develop and commercialize the humanized anti-CD3 monoclonal antibody TRX4 (otelixizumab) for Type I diabetes and other autoimmune and immune-mediated inflammatory diseases. BTG is entitled to receive 50 percent of any future milestone payments received by Tolerx and has rights to royalties on product sales also.
• Elan Corp. plc, of Dublin, Ireland, said Johnson & Johnson Pharmaceutical Research & Development LLC, a subsidiary of Johnson & Johnson, of New Brunswick, N.J., has submitted a new drug application to the FDA for paliperidone palmitate, an investigational, once-monthly atypical antipsychotic intramuscular injection for schizophrenia and the prevention of recurrence of the symptoms of schizophrenia. Paliperidone palmitate is a long-acting injectable ester of the active ingredient in Invega and utilizes Elan's NanoCrystal Technology. Under the terms of Elan's license agreement with J&JPRD, it is eligible to receive payments for milestones and royalty payments based on sales if the product is commercialized.
• Glycominds Ltd., of Lod, Israel, has entered into a research agreement with the Fox Chase Cancer Center in Philadelphia, part of the National Cancer Institute, to collaborate on a breast cancer diagnostic blood test using Glycominds' anti-glycan antibodies biomarkers. Glycominds also is planning an early 2008 U.S. launch of its lead product, IBDX, a blood test for inflammatory bowel disease and Crohn's disease.
• Innate Pharma SA, of Marseille, France, announced the launch of another Phase IIa clinical trial of IPH 1101, the lead drug candidate derived from the company's T cell platform, in the indication of chronic myeloid leukemia (CML). That will be the fourth exploratory Phase II trial conducted of IPH 1101 and the third in oncology. The drug already is being tested in metastatic renal cell carcinoma, follicular lymphoma and Type C viral hepatitis. A fifth Phase II trial of IPH 1101 will be conducted in a solid tumor indication (in which it will be administered in combination with a cytotoxic agent). The company plans to submit an application for that trial before the year-end. The first results from the Phase IIa trial in metastatic renal cell carcinoma should be available during the first part of 2008, while initial data from the other trials are expected later in 2008 and in 2009.
• Nycomed Denmark A/S, of Roskilde, Denmark, has licensed rights to distribute the synthetic bone hemostasis material Ostene from Ceremed Inc., of Los Angeles. The product is designed to stop bone bleeding in surgery that does not interfere with bone healing or increase the risk of surgical infections, including methicillin-resistant Staphylococcus aureus. It is used in cardiac, orthopedic and neurosurgery. Terms were not disclosed.
• Orexo AB, of Uppsala, Sweden, and Lake Forest, Ill.-based Hospira, a pharmaceutical delivery company, signed an agreement giving Hospira exclusive marketing and selling rights to Rapinyl, Orexo's sublingual tablet for break-through cancer pain. Hospira will market the drug in Australia, New Zealand and other Asian Pacific areas, and shoulder the responsibility for regulatory approval in those markets. Kyowa Hakko Kogyo Co. Ltd., of Tokyo, markets Rapinyl in Japan, and Eno Pharmaceuticals, of Chadds Ford, Pa., has distribution rights in North America.
• Sunway Biotech Co. Ltd., of Shanghai, China, and Genzyme Corp., of Cambridge, Mass, said they will collaborate to manufacture, develop and commercialize Genzyme's gene therapy Ad2/HIF-1a in China. The product is in Phase II clinical testing in more than 300 patients at 40 sites in the U.S. and Europe. Ad2/HIF-1a is an engineered form of the HIF-1a gene designed to promote the growth of new blood vessels and improve circulation in the limbs of patients with peripheral arterial disease. Under the collaboration with Sunway, Genzyme will transfer its process for manufacturing Ad2/HIF-1a to Sunway, which will produce the product at its Shanghai facility for clinical trials. Sunway will design, fund and conduct Phase I and Phase II studies in China.