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Nemus Bioscience Announces Milestones in the Development of Fully Synthetic Clinical-Grade Active Pharmaceutical Ingredient (API) for Drug Candidates NB1111 and NB2111 and Formulation Contract with AMRI and Catalent Pharma Solutions

COSTA MESA, CA / ACCESSWIRE / December 1, 2016 / NEMUS Bioscience, Inc. (OTCQB: NMUS) announced that work performed in conjunction with its API contract developer and manufacturer, Albany Molecular Research Inc. (NASDAQ: AMRI), resulted in a synthetic pathway to manufacture the clinical-grade proprietary prodrug tetrahydrocannabinol-valine-hemisuccinate (THCVHS), including the ability to scale-up production. In addition, the purity of the API achieved a standard exceeding FDA requirements of being at least 99.5% pure. Nemus has subsequently contracted with Catalent Pharma Solutions (Catalent) to begin formulation work associated with NB2111, the candidate product for managing chemotherapy-induced nausea and vomiting (CINV).

"Reliable and consistent API manufacturing is a major step necessary for human testing, regulatory approval and ultimate commercialization of a candidate molecule. The Nemus cannabinoid compounds of NB1111, which is intended for the treatment of glaucoma and NB2111, which is intended for managing chemotherapy-induced nausea and vomiting (CINV) both utilize the patented prodrug of THC as the active ingredient," commented Brian Murphy, M.D., M.B.A., CEO and Chief Medical Officer of Nemus. "In preparing for a pre-IND meeting with the FDA, the company is focused on formulation development of NB1111 and NB2111 to meet chemistry-manufacturing-controls (CMC) requirements of the FDA. We are working with Catalent in the formulation process to achieve a clinical-grade delivery of NB2111 in CINV."

"The company is exploring formulation options for the delivery of NB1111 into the eye. Nemus anticipates this process to be completed in the first quarter of 2017 resulting in a collaboration with an ocular drug delivery formulator that will help bring the candidate- glaucoma therapy forward to satisfy regulatory requirements for human testing," stated Dr. Murphy.