M Pharmaceutical In-Licenses Novel Pediatric Orphan Drug
M Pharmaceutical Inc. recently announced that it has in-licensed a novel drug product that should qualify as an Orphan Drug under the US Orphan Drug Act. This new drug and its orphan status should also qualify for a Rare Pediatric Disease designation and a Priority Review Voucher (PRV). PRV’s are incentives designed by the FDA to spur the development on new treatments for diseases that would otherwise not attract development interest from companies due to the cost of development and lack of market opportunities (very small patient populations). M Pharma has structured the in-license agreements by forming a private joint venture LLC with the inventor and group of private investors associated with inventor, as minority stakeholders.
“We have an opportunity with this new technology to fill an unmet pediatric need,” said Gary Thompson, President and CEO of M Pharma. “Current treatments on the market can run in the hundreds of thousands/years for treatments and none are FDA approved for infants younger than 2 years of age.
“Our goal is to not only provide assistance to families fighting these Rare Pediatric Diseases but to also add a valuable Priority Review Voucher asset to M Pharma that offers the potential of a third-party transfer for hundreds of millions of dollars, which would be used to fund additional drug development.”
Formed in early 2015, M Pharmaceutical Inc. is a clinical-stage company developing innovative technologies for obesity, weight management, and female health and wellness. In addition to its recent acquisitions of C-103, a reformulation of Orlistat and assets from 40J’s LLC, the company is scheduled to launch their FDA cleared fertility product branded as ToConceive sometime in the third quarter of 2017. M Pharmaceutical Inc. trades on the Canadian Securities Exchange (CSE) under the ticker symbol MQ as well as on the OTCQB as MPHMF and FWB (Frankfurt Stock Exchange) as T3F2.
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