RespireRx Takes Step to Advance Dronabinol Obstructive Sleep Apnea Program with Letter of Intent for Co-Development and Supply Agreement
On June 13, 2018, RespireRx Pharmaceuticals Inc entered into a letter of intent with Noramco Inc, a producer of controlled substances bulk APIs for the pharmaceutical industry, pursuant to which the parties have entered into a 90-day period during which they will negotiate a definitive agreement regarding the RespireRx’s development of dronabinol.
Subject to successful completion of due diligence and execution of a definitive agreement, RespireRx 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 Δ9-tetrahydrocannabinol or Δ9-THC and is approved and marketed by other companies both as a branded product and in generic formulations for anorexia associated with AIDS and chemotherapy induced nausea and vomiting. It is theRespireRx’s intention to develop its own branded dronabinol for the treatment of obstructive sleep apnea (OSA).
The letter sets out the principal terms of an intended agreement that would address: the company’s agreement to purchase dronabinol exclusively from Noramco Inc and/or its affiliates at a fixed rate, most of which is anticipated to occur at or after commercialization commences and 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.
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,” says Arnold Lippa, PhD, RespireRx’s executive chairman and chief scientific officer, in a release. “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.”
In a separate release, RespireRx Pharmaceuticals Inc announces the decision of James S. Manuso, PhD, MBA, to resign as president, CEO, vice chairman and member of the board of directors, effective as of September 30, 2018, the expiration date of his contract. He will remain in these positions until that date. In the future, Manuso will devote his full time attention to the management of Talfinium Investments Inc., a healthcare investment and merchant banking firm he established in 2013.
from Sleep Review http://www.sleepreviewmag.com/2018/06/respirerx-dronabinol-obstructive-sleep-apnea/