VANCOUVER, B.C., CANADA (9 August, 2016) – M Pharmaceutical, Inc. (CSE:MQ, OTCQB: MPHMF, FWB:T3F2 ), (the "Company"), a clinical-stage company developing innovative technologies for obesity and weight management, will release the first of three clinical studies for C-103 as soon as the data is compiled and interpreted.
The Company recently expanded its product pipeline with the recent C-103 acquisition from Chelatexx. Combined with existing Company obesity and weight management technology, the Chelatexx acquisition opens up a wide range of new possibilities to treat the disease. This focus on the ever growing obesity and weight management area is the foundation of the Company’s business plan.
To facilitate the most effective growth model, M Pharmaceutical has incorporated a wholly owned subsidiary, M Pharmaceutical USA Inc., which will be the Company’s operating entity for its production, testing and marketing of its C-103 project, the reformulated Orlistat drug recently acquired. This company will operate out of the Greater Cincinnati region and with Mr. Gary Thompson of Fort Thomas, Kentucky serving as President of the Company.
Gary has been intimately involved in the creation of C-103, and has the experience to oversee the various steps needed over the twelve to twenty four months to get this drug to market.
M Pharmaceutical carries a strong patent position to protect its technologies, strengthening the upside potential of its current valuation. The Company will continue to develop its presence in the investment community, especially in the United States; the largest and most important market for biomedical technologies in the world. In addition, it will be finalizing the appointment of key individuals in the coming months, including additional board members and consultants to the Company.
M Pharmaceutical is developing patented, best-in-class, orally administered products for weight loss: C-103. A novel formulation of Orlistat, C-103 has the potential to help patients lose significant weight with an acceptable side effect profile as compared to currently marketed products.
The Company’s mission is to being a leader in the management of obesity and weight loss, with 27% of the world population overweight or obese. Approximately 2.8 million people die annually as a result of being obese or overweight. More than $190 billion USD is spent annually on medical costs due to obesity in the U.S. alone. The global weight management market is
forecast to grow 6.9% annually - from $148.1 billion (2014) to $206.4 billion (2019). The market for oral medications is expected to grow 29% annually during the same time frame.
A key concern is that the sales potential of current weight loss treatments has been limited due to significant downsides (from serious adverse events to socially unacceptable side effects). M Pharmaceutical believes its C-103 development-stage product has the potential to treat obesity with fewer side effects than other currently available oral therapies.
Product Development Overview
C-103 is a novel formulation of Orlistat, patented until 2030 in the U.S. Orlistat is FDA-approved for weight management is currently 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. However, orlistat causes socially unacceptable “underwear issues” including fecal urgency/incontinence, oily discharge, flatus with discharge, and fatty/oily/liquid stools. As a result of these well-publicized side effects and the entry of new competitive drugs, Orlistat annual sales have declined to about $200 million in recent years.
C-103 is intended to maintain the efficacy of Orlistat while minimizing its socially unacceptable side effects. The FDA has confirmed that C-103 is eligible for U.S. approval under a 505(b)(2) pathway which would expedite C-103 approval versus traditional drug approval pathways. If clinical trials establish (a) the bioequivalence of C-103 with Orlistat and (b) that C-103 significantly reduces the “underwear issues” of orlistat as expected, M Pharmaceutical estimates peak sales for the product of over $200 million per year.
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 the intended acquisition of C-103 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.
M Pharmaceutical 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:
Phone: +1 604 428 0511
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 its biomedical 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.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 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 otherinternational regulatory body.