Better Health. Better Life.

M Pharmaceutical Inc. Previews Business Strategy For Developing And Commercializing Prescription Strength C-103, Reformulated Orlistat

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.”

For more information contact:
Investor Relations
Phone: +1 604 428 0511          
info@m-pharma.ca
www.m-pharma.ca

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.  

Drug Treatment Portfolio

Obesity, Weight Management Treatment

C-103 is a novel reformulation of orlistat, patented until 2030 in the U.S.  Orlistat is FDA-approved for weight management and sold by Roche as Xenical® (prescription) and by GlaxoSmithKline as alli® (over-the-counter).  Proven safe and effective in over 100 clinical trials, orlistat is the best-selling weight loss medication of all time with peak sales over $900 million in 2007.  The C-103 reformulation addresses adverse events reported by over 90% of orlistat users. These adverse events have led to the decline in Orlistat sales to approximately $200 million in recent years. 

C-103 is intended to maintain the efficacy of orlistat while minimizing its socially unacceptable adverse events. Unlike other weight loss drugs:

  • Orlistat is not an amphetamine
  • Orlistat does not affect the central nervous system
  • Orlistat is not systemically absorbed
  • Orlistat is the only FDA-approved OTC weight loss drug because of its safety
  • Orlistat is the only FDA-approved weight loss drug for adolescent patients (age 12-18)

Infertility Treatment

ToConceive is an innovative new infertility treatment that offers hope and assistance to the millions of couples worldwide struggling to start a family. Our product is an easy to use topical gel that helps to balance the pH of the vagina and is clinically proven to increases a women’s natural production of transudate (sexual lubrication). This increase in natural transudate is required for successful “Sperm Capacitation” to occur. Without the process of Sperm Capacitation, the sperm would not have the ability to travel the required distance to the ovum or have the appropriate chemical makeup for successful conception to occur.

ToConceive is a women’s health treatment supported by a FDA 510K clearance and is protected by four USPTO patents. ToConceive’s proven ability to increase a woman’s natural production of transudate results in significantly higher success rates for couples trying to conceive, without the added expense, or stress, associated with assisted reproduction treatments.