CINCINNATI, OH, USA (June 29, 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 will be pursuing a Joint Venture or Strategic Alliance for the development of its C-103 re-formulated Orlistat drug product. M Pharma recently announced a successful response to a pre IND Meeting Response Letter and Package from the US Food and Drug Administration (FDA) for the definitive clinical development plan through the 505(b)(2) pathway; under which the FDA is permitted to rely on data not developed by the applicant – such as published literature or the FDA’s finding of safety and/or effectiveness of a previously approved drug product.
“Now that we have a positive response from the FDA in hand, our plans for the development of C-103 are advancing quickly”, said Gary Thompson President & CEO of M Pharmaceutical Inc. “These plans include establishing a Joint Venture or Strategic Alliance with the appropriate partner who has the financial resources, drug development experience and an existing distribution infrastructure required for C-103 to global commercialization”, said Mr. Thompson.
C-103 & Orlistat Background Information
The development goal for the C-103 drug product is to maintain the proven efficacy of Orlistat for weight reduction or weight maintenance while minimizing or eliminating the undesirable adverse events (underwear issues) experienced by millions of patients. M Pharma holds issued U.S. patents covering C-103 technology until 2030.
Orlistat monotherapy is currently approved as a prescription product, under NDA 020766 (Xenical Capsules, 120 mg) and as an over-the-counter (OTC) drug, under NDA 021887 (Alli Capsules, 60 mg). Xenical is indicated as a treatment for obesity management, including weight loss and weight maintenance in conjunction with a reduced-calorie and low-fat diet; for individuals with a BMI of 30 or greater (obese); or 27 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes). Orlistat has been proven safe and effective in numerous clinical trials and remains the only FDA-approved weight management drug for the adolescent population (12 years and older). Orlistat, unlike all the other branded & generic prescription drugs for obesity, does not affect the central nervous system and it is not systemically absorbed. Recent sales of Orlistat have declined from its peak due to uncomfortable and well-publicized adverse event of the product.
About the US Obesity Market
Today 38% percent of American adults over 20 and 17.2% of children over age 7 are obese in the U.S., and an additional 30% are classified as overweight. The annual health cost related to obesity in the U.S. is nearly $200 billion, and nearly 21% of all medical cost in the U.S. can be attributed to obesity.
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, 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.