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Advancing Dronabinol Obstructive Sleep Apnea Program with Letter of Intent for Co-Development and Supply Agreement with Noramco, Inc.
BY GlobeNewswire
— 8:45 AM ET 06/19/2018
Glen Rock, N.J., June 19, 2018 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. ( RSPI ) (“RespireRx” or the “Company”), is pleased to announce that on June 13, 2018, it entered into a letter of intent (“LOI”) with Noramco, Inc., pursuant to which the parties have entered into a ninety-day period during which they will negotiate a definitive agreement regarding the Company’s development of dronabinol. Subject to successful completion of due diligence and execution of a definitive agreement, the Company and Noramco will cooperate in the co-development of both a first-generation gel capsule of dronabinol in sesame oil and a second-generation modified formulation of dronabinol with enhanced pharmaceutical properties. Dronabinol is a synthetic cannabinoid, also known as ?9-tetrahydrocannabinol or ?9-THC and is approved and marketed by other companies both as a branded product and in generic formulations for anorexia associated with AIDS and chemo-therapy induced nausea and vomiting. It is the Company’s intention to develop its own branded dronabinol for the treatment of obstructive sleep apnea (OSA).
The LOI sets out the principal terms of an intended agreement that would address: (i) the Company’s agreement to purchase dronabinol exclusively from Noramco Inc. and/or its affiliates (“Noramco”) at a fixed rate, most of which is anticipated to occur at or after commercialization commences and (ii) Noramco’s obligation to provide 100% of the active pharmaceutical ingredient (“API”) for the clinical development process for both the first- and second-generation products, three validation batches for NDA filing(s) and adequate supply for the initial inventory stocking for the wholesale and retail channels, subject to certain thresholds, as well as other aspects of the supply chain.
In summary, it is contemplated that the parties will agree for Noramco to provide a substantial portion of the supply chain inventory and infrastructure in exchange for a supply agreement and a limited participation in the success of the products upon launch. RespireRx would receive in-kind contributions of API inventory and supply chain services through the clinical development process and support into commercial launch.
“We are very pleased and excited to enter into this joint development agreement with Noramco, a leading dronabinol manufacturer,” said Dr. Arnold Lippa, the Company’s Executive Chairman and Chief Scientific Officer. “Noramco’s involvement greatly enhances the credibility of this project and their depth of expertise, will allow us to focus on the clinical and regulatory aspects of developing our dronabinol product, comfortable in the knowledge that the supply side development will be in very capable hands.”
