Retrophin, Shin Nippon Biomedical Laboratories, Transcept deal
Shin Nippon granted Transcept exclusive, worldwide rights to develop and commercialize Shin Nippon's TO-2070 for $1 million up front. Shin Nippon will be eligible to receive $6.5 million in milestones through NDA approval and commercial milestones up to $35 million, plus tiered, low double-digit royalties. TO-2070 is an intranasal formulation of dihydroergotamine (DHE), a serotonin (5-HT) receptor agonist, delivered via Shin Nippon's nasal powder delivery technology. The product is in preclinical testing to treat acute migraine. Transcept plans to begin a clinical pharmacokinetic trial in 2H14. The company hopes to develop TO-2070 under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. TO-2070 is now listed as Transcept's lead compound.
Earlier this month, Transcept shareholders Roumell Asset Management LLC and New Leaf Venture Partners sent letters to Transcept's board saying they do not believe Transcept's plan to acquire a new product, along with its associated costs and risks, are in the best interests of shareholders. Instead, Roumell suggested the company begin an immediate buyback program while remaining liquid enough to pursue other possible strategies for insomnia drug Intermezzo zolpidem tartrate (see BioCentury, Sept. 16). ...