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M Pharmaceutical Inc (2)
Symbol MQ
Shares Issued 110,540,814
Close 2016-11-28 C$ 0.045
Market Cap C$ 4,974,337
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M Pharma to seek C-103 indications for liver disease

2016-11-29 07:17 ET - News Release

Mr. Gary Thompson reports

M PHARMACEUTICAL INC. PREVIEWS BUSINESS STRATEGY FOR DEVELOPING AND COMMERCIALIZING PRESCRIPTION STRENGTH C-103, REFORMULATED ORLISTAT

M Pharmaceutical Inc. 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 Food and Drug Administration approved for weight management and sold by Roche as Xenical (prescription) and by GlaxoSmithKline as alli (over the counter/OTC). Orlistat is the bestselling 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 120 milligrams) to address numerous existing and supported indications. This approach is possible in light of the previous FDA approval for Rx Xenical (120 mg orlistat) in 1999.

In addition to the most prevalent indication for the adult population to prevent the progression of prediabetes to frank diabetes Rx C-103 (orlistat 120 mg) will be indicated for the growing adolescent population aged from 12 to 16. M Pharma is announcing that it will be seeking indications for the prevention of non-alcoholic fatty liver disease (NAFLD) and for non-alcoholic 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 Centers for Disease Control and Prevention reports that in 2012 the prevalence of adolescent obesity in the United States was 21 per cent. The U.S. prevalence of prediabetes was 40 per cent, representing over 100 million U.S. adults. The U.S. prevalence of adult non-alcoholic fatty liver disease (NAFLD) is reported as 30 per cent. 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 chief executive officer 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 Mr. Thompson.

About M Pharmaceutical

M Pharmaceutical 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.

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