BioLineRx has licensed Santhera Pharmaceuticals’ preclinical melanocortin-4 receptor (MC-4R) antagonist program for the treatment of cancer cachexia. The deal gives BioLineRx all rights to develop, sublicense, and commercialize the compound. The firm will also be responsible for all associated costs. Santhera will receive 22-25% of all BioLineRx’ sublicensing income, or royalites on future sales.
Santhera says the deal is in line with its strategy to focus on core late-stage or marketed products, namely Catena®, fipamezole, and omigapil. “We received considerable interest in this progam and concluded that BioLineRx is the best partner for development of our selective, first-in-class MC-4R antagonists based on their excellent track record in developing similar stage assets to proof-of-concept in man,” remarks Klaus Schollmeier, Santhera CEO.
Catena is marketed in Canada for the treatment of Friedreich’s ataxia. The drug is also in Phase III development for treating Duchenne muscular dystrophy, and in MELAS syndrome, and primary progressive multiple sclerosis. In September Santhera said it plans to submit a Marketing Authorization Application for Catena in the treatment of Leber's hereditary optic neuropathy during the first half of 2011. Regulatory approval filing discussions with regulatory authorities in other countries are also ongoing for this indication.
Fipamezole has successfully completed a confirmatory Phase IIb trial in the treatment of dyskinesia in Parkinson disease patients. It has been licensed for the U.S. and Canadian markets to Valeant (formerly Biovail) and to Ipsen for markets outside North America and Japan. Omigapil is in development for treating congenital muscular dystrophy, and is currently being prepared for Phase II/III trials.