Date: 2014-11-06
Type of information: Licensing agreement
Compound: gacyclidine
Company: Ipsen (France) Otonomy (USA - CA)
Therapeutic area: Otorhinolaryngology
Type agreement: licensing
Action mechanism: Gacyclidine is a potent and selective antagonist of the NMDA receptor. Clinical studies, including pilot studies conducted with gacyclidine, support the use of NMDA receptor antagonists as a potential treatment for tinnitus. OTO-311 utilizes Otonomy’s proprietary drug delivery technology to achieve sustained exposure of gacyclidine in the inner ear from a single intratympanic (IT) injection.
Disease: tinnitus
Details: * On November 6t, 2014, Otonomy, a clinical-stage biopharmaceutical company focused on the development and commercialization of herapeutics for diseases and disorders of the inner and middle ear, and Ipsen, a global specialty-driven pharmaceutical company, announced that they have entered into an exclusive licensing agreement enabling Otonomy to utilize Ipsen’s gacyclidine data in the development and registration of OTO-311. OTO-311 is Otonomy’s sustained-exposure formulation of gacyclidine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, in development for the treatment of tinnitus.
Under the terms of the agreement, Otonomy will have an exclusive license to use Ipsen’s clinical and non-clinical gacyclidine data to support worldwide development and regulatory filings for OTO-311. These data include non-clinical studies which supported Ipsen’s initiation of clinical studies for systemic administration of gacyclidine, and clinical data from several Phase 1 and Phase 2 clinical trials conducted by Ipsen. In total, more than 300 patients were treated with systemic gacyclidine as a potential neuroprotectant in various neurologic trauma indications.
Financial terms: Financial terms of the agreement were not disclosed.
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