RespireRx Pharmaceuticals Inc has entered into a dronabinol development and supply agreement with Noramco Inc, a North American producer of controlled substances bulk active pharmaceutical ingredients (API). RespireRx is developing dronabinol for obstructive sleep apnea. RespireRx believes, subject to meeting with the Food and Drug Administration, that dronabinol is Phase 3 ready.
Under the terms of the agreement, Noramco agreed to provide all of the active pharmaceutical ingredient (API) estimated to be needed 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 limitations; maintain or file valid drug master files with the FDA or any other regulatory authority and provide the company with access or a right of reference letter entitling the company to make continuing reference to the DMFs during the term of the agreement in connection with any regulatory filings made with the FDA by the Company; participate on a development committee; and (make available its regulatory consultants, collaborate with any regulatory consulting firms engaged by the company and participate in all FDA or Drug Enforcement Agency meetings as appropriate and as related to the API.
In consideration for these supplies and services, the company agreed to purchase exclusively from Noramco during the commercialization phase all API for its products at a pre-determined price subject to certain producer price adjustments, and agreed to Noramco’s participation in the economic success of the commercialized product or products up to the earlier of the achievement of a maximum dollar amount or the expiration of a period of time.
“We are very pleased and excited to enter into this development and supply agreement with Noramco, a leading dronabinol manufacturer,” says Arnold Lippa, PhD, the company’s executive chairman and chief scientific officer, in a release. “There are significant FDA and DEA regulatory and manufacturing complexities surrounding the dronabinol supply chain, considered a DEA Schedule I drug as API and a Schedule III drug as a gel capsule. Through this arrangement with Noramco, we believe that we have solved not only some of our regulatory concerns, but also secured appropriate manufacturing capacity. We believe that the potential OSA market is extremely large, many times larger than the current market for dronabinol for currently approved indications, so the commitment by Noramco to provide clinical material and to ensure commercial supply demonstrates our mutual belief that dronabinol for OSA can be a commercial success.”
“Supplying a high-purity dronabinol to RespireRx to meet such a significant unmet medical need reflects the core of our capability,” said Tim Jones, Director of Global Cannabinoids Portfolio, Noramco. “We appreciate that RespireRx recognizes our ten years of experience in cannabinoids manufacture for pharmaceutical products, including the regulatory and supply chain expertise we bring to DEA Schedule I through III APIs. We look forward to partnering with RespireRx with high-quality dronabinol as the company moves toward regulatory approval.”
from Sleep Review http://www.sleepreviewmag.com/2018/09/respirerx-pharmaceuticals-secures-clinical-supply-dronabinol-obstructive-sleep-apnea/