VANCOUVER, B.C., CANADA (November 29, 2016) - M Pharmaceutical Inc. (CSE: MQ, OTCQB: MPHMF, FWB: T3F2), (the "Company" or “M Pharma”), is providing a preview of the business strategy for the commercialization of its recently acquired C-103 Project.
C-103 is a patented, proprietary combination of orlistat, simethicone and activated charcoal, which is designed to maintain the efficacy of orlistat while minimizing its bowel-related side effects. Orlistat is FDA-approved for weight management and sold by Roche as Xenical™ (Prescription) and by GlaxoSmithKline as alli™ (Over-The-Counter/OTC). Orlistat is the best-selling weight loss medication of all time with peak sales of over $900 million in 2007. The drugs are not systemically absorbed, have strong safety profiles and are approved by the FDA.
M Pharma, working with its contracted partners, is enacting an innovative regulatory strategy to develop its prescription (Rx) C-103 (orlistat 120mg) to address numerous existing and supported indications. This approach is possible in light of the previous FDA approval for Rx Xenical™ (120mg orlistat) in 1999.
In addition to the most prevalent indication for the adult population to prevent the progression of pre-diabetes to frank diabetes Rx C-103 (orlistat 120mg) will be indicated for the growing adolescent population aged from 12-16. M Pharma is announcing that it will be seeking indications for the prevention of nonalcoholic fatty liver disease (NAFLD), and for nonalcoholic steatohepatitis (NASH), a widely growing indication among the obese population. Clinical trials have been completed to support this indication, but not yet submitted to the FDA.
The CDC reports that in 2012, the prevalence of adolescent obesity in the US was 21%. The US prevalence of pre-diabetes was 40%, representing over one hundred million US adults. The US prevalence of adult nonalcoholic fatty liver disease (NAFLD) is reported as 30%. These significant and growing markets represent the central revenue driving opportunities for the Company.
“This strategy to focus on previously approved indications for adolescent obesity coupled with a focus on new indications for NAFLD and NASH requires intense focus by multiple scientific teams working to ensure a seamless and successful development process,” said Gary Thompson, President and CEO of M Pharmaceutical USA. “According to the World Health Organization, 1.9 billion adults globally are overweight or obese. Obesity increases the risk of heart disease, diabetes, kidney complications, joint disorders and certain cancers. M Pharma has a unique opportunity with C-103 to make a significant impact in treating this world epidemic.” said Thompson.
About M Pharmaceutical Inc.
Formed in early 2015, M Pharmaceutical Inc. is a clinical-stage company developing innovative technologies for obesity and weight management. In addition to its recent acquisition of C-103, a reformulation of orlistat from Chelatexx, LLC, the Company will focus on the development of its Trimeo capsules, temporary controllable pseudobezoars for non-invasive gastric volume reduction for the treatment of obesity, for which it has exclusive rights. The Company has also recently acquired an FDA cleared fertility product branded as ToConceive that represents its first offering in the women's health field.
M Pharma 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.”
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 commercialization of the rights to the Company’s biomedical & drug technologies. 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.thecse.com 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 Trimeo 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.