CINCINNATI, OH, USA (July 5, 2017) – M Pharmaceutical Inc. (CSE: MQ, OTCQB: MPHMF, FWB: T3F2), (the “Company” or “M Pharma”), a clinical-stage company developing innovative technologies for weight management and female health and wellness, today 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 a unmet pediatric need”, said Gary Thompson, President and CEO of M Pharma. “Current treatments on the market can run in the hundreds of thousands / year for treatments and none are FDA approved for infants younger than two years of age”, said Mr. Thompson.
“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”, added Mr. Thompson.
About Orphan Drug Development, Rare Pediatric Diseases and Priority Review Vouchers
Orphan Drug Act: Since the 1984 passage of the Orphan Drug Act, the US has begun to recognize that incentives can help spur development of new drugs for historically underserved conditions. Under the Orphan Drug Act, companies are eligible for several extra years of marketing exclusivity, during which time FDA is not permitted to approve a generic, as additional benefit for getting a “rare” disease drug approved. This gives companies an added incentive to produce drugs intended for rare diseases; it allows the company extra time to recoup its development costs and likely turn a profit as well.
Priority Review: Most drugs are reviewed by FDA under “standard” review times; meaning FDA has 10 months to review each product before it is supposed to render a decision. However, the review clock stops each time the FDA requests additional information from a sponsor, adding several months to the review process. However, for certain drugs, FDA accelerates its regulatory review in the hopes of getting products to market more quickly. For companies and patients alike, FDA’s priority review process can be extremely beneficial; for companies, it means they can market their product more quickly and begin recouping their often considerable development costs.
Priority Review Voucher: FDA’s priority review vouchers are incentives meant to spur the development of new treatments for diseases that would otherwise not attract development interest from companies due to the cost of development and the lack of market opportunities. To do this, companies are given a special voucher which allows them to have any one of their drugs reviewed under FDA’s priority review system.
Rare Pediatric Disease Voucher: The rare pediatric voucher was created in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), and specifically targets the need for additional therapies for rare pediatric subsets of other diseases. Section 908 of FDASIA defines a “rare pediatric disease” as one which “primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children and adolescents,” and is a rare disease according to federal statute (200,000 persons in the US or fewer).
Priority Review Voucher Sale & Transfer: PRV’s, as mentioned above, can be sold to other companies for expedited/priority review of any drug under development. BioMarin’s voucher, the first ever to be sold, was purchased for $67 million. Several months later, Gilead Sciences purchased Knight Therapeutics’ voucher for $125 million. In May 2015, Sanofi purchased yet another voucher for a record-setting $245 million, and in August 2015, AbbVie shattered that record by paying $350 million for a voucher originally awarded to United Therapeutics. However, since then the selling price for PRVs has continued to slide, with Gilead paying $200 million for a voucher in 2016, and $125 million for one in February 2017
About M Pharmaceutical
Formed in early 2015, M Pharmaceutical Inc. is a clinical-stage company developing innovative technologies for obesity, weight management and female health & 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.”
For more information contact:
M Pharma Investor Relations
Phone: +1 (859) 868-3131
Notice regarding Forward Looking Statements: This news release contains forward-looking statements. The use of any of the words “anticipate”, “continue”, “estimate”, “expect”, “may”, “will”, “project”, “should”, “believe” and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. This news release includes forward-looking statements with respect to the regulatory approval, commercialization of the rights to the Company’s biomedical & drug technologies, the value of priority review vouchers and acquisition of new products. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this news release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company’s disclosure documents which can be found under the Company’s profile on www.sedar.com and the Company’s filings to the CSE at www.cnsx.ca. Such risk factors may cause the inability of the Company to successfully commercialize any of its biomedical technologies.
Notice regarding investigational devices: C-103 and Extrinsa are investigational drugs or devices and are not currently available outside of approved clinical trials. Claims regarding the safety and efficacy of these devices have not been evaluated by Health Canada, the U.S. Food and Drug Administration, or any other international regulatory body.