Ear disease-focused firm Otonomy has entered an agreement with Ipsen allowing Otonomy to use Ipsen's gacyclidine data in the development and registration of OTO-311, Otonomy's sustained-exposure formulation of gacyclidine in development for the treatment of tinnitus. Gacyclidine is an N-Methyl-D-Aspartate (NMDA) receptor antagonist; according to Otonomy, clinical studies show NMDA receptor antagonists could be used to treat the ear disorder.

Otonomy is getting an exclusive license to use Ipsen's clinical and nonclinical gacyclidine data to support worldwide development and regulatory filings for OTO-311, including data from nonclinical studies supporting Ipsen's initiation of clinical studies for systemic administration of gacyclidine, and clinical data from Phase I and Phase II trials Ipsen has conducted. Ipsen says over 300 patients in total were treated with systemic gacyclidine as a potential neuroprotectant in various neurologic trauma indications.

“Tinnitus is a debilitating disorder for which there are no FDA-approved drug treatments,” Ipsen's evp and CSO Claude Bertrand said in a statement. “Through this agreement, we are pleased that prior R&D studies with gacyclidine, conducted by Ipsen, could support Otonomy's development of OTO-311 for use in a population where there is a need for new therapeutic options.”

In October of 2013, Otonomy announced that it picked up certain assets and IP rights from an affiliate of NeuroSystec—a company founded to develop a drug-device combination product that could provide sustained delivery of gacyclidine to the inner ear—related to the use of gacyclidine for the treatment of tinnitus. Otonomy received the preclinical, clinical, and manufacturing data NeuroSystec produced in its development of gacyclidine and also acquired IP rights that augment the current patent estate protecting OTO-311, including patent applications.

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