RespireRx Pharmaceuticals Inc, which is researching and developing cannabinoids for the treatment of sleep-related breathing disorders, has entered into a non-binding memorandum of understanding and exclusivity agreement with Impression Healthcare Ltd. The non-binding memo is for the purpose of negotiating terms by which the parties would enter in an arrangement, such as a license, joint venture, or partner agreement, so as to commercialize dronabinol for the treatment of obstructive sleep apnea (OSA) in Australia, New Zealand, and Southeast Asia.
To date, RespireRx has focused on dronabinol development in the United States. However, Australia also represents a potentially significant market opportunity. According to SNORE Australia, approximately 9% of women and 25% of men in Australia have clinically significant OSA.
As an alternative to CPAP, Impression currently markets and sells the Sleep Guardian Dorsal, a dental mandibular advancement device, which is sold through the company’s Preferred Practitioner Network. On December 4, 2018, Impression disclosed its intentions for commercializing dronabinol for certain indications and on February 15, 2019, disclosed its discussions with RespireRx about OSA.
The initial intent of the parties is to create an appropriate commercial vehicle in order to rapidly introduce dronabinol to the Australian market through the Special Access Scheme, which permits, under certain circumstances, prescriptions of identified unregistered drug products. It is anticipated that this potentially rapid commercialization will be followed by the introduction of a registered product following the completion of RespireRx’s planned phase 3 clinical trial program and marketing authorization.
“RespireRx looks forward to its discussions with Impression,” says Arnold Lippa, PhD, executive chairman, chief scientific officer and interim CEO of RespireRx, in a release. “Their ability to access the Australian OSA market through their existing distribution and sales network, along with their commitment to commercializing dronabinol, makes them an ideal partner to bring dronabinol to this market.”
Joel Latham, CEO of Impression, says, “Dronabinol has the potential to change the way in which sleep apnea is treated throughout the world and we’re excited to work with Respire towards our mutual goal to open this new market for dronabinol.”
from Sleep Review http://www.sleepreviewmag.com/2019/02/respirerx-commercialization-dronabinol/