VANCOUVER, B.C., CANADA (27 October, 2016) –Mr. Brian Keane, President & Chief Executive Officer of M Pharmaceutical Inc. (CSE: MQ, OTCQB: MPHMF, FWB: T3F2 ), (“M Pharma” or the "Company"), a clinical-stage company developing innovative technologies for obesity and weight management, has issued a comprehensive update letter to shareholders.
Dear Shareholders of M Pharmaceutical Inc:
I would like to take this opportunity to provide an update on the Company’s growth initiatives and enhancement of shareholder value. The Company continues to make good progress with our product pipeline. We have retained Camargo Pharmaceutical Services in order to expedite the clinical trials process for C-103, our recently acquired reformulated orlistat drug technology. Combined with existing Company expertise in obesity and weight management, the C-103 acquisition opens up a wide range of new possibilities to treat the disease. The Company’s focus and expertise in the obesity and weight management area will enable us to develop and succeed in an increasingly competitive marketplace.
M Pharma carries a strong patent position to protect our technologies, strengthening the upside potential of our 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. We will be continually focused on the development of our portfolio through strategic acquisitions in the obesity, weight management and women’s health spaces. As we progress there will be further appointments of key individuals to the M Pharma team, including board members and consultants to the Company.
2016 Year to Date Highlights
- M Pharma acquired the rights to C-103. C-103 is a novel formulation of orlistat, patented until 2030 in the United States. Orlistat is FDA-approved for weight management and sold by Roche as Xenical® (prescription) and by GlaxoSmithKline as alli® (over-the-counter). Orlistat is the best-selling weight loss medication of all time with peak sales over $900 million in 2007. C-103 is intended to maintain the efficacy of Orlistat while minimizing its socially unacceptable side effects.
- M Pharma has entered into a letter of intent to acquire from ToConceive LLC., a private pharmaceutical company, the rights to an FDA cleared women’s health product for use as an infertility treatment in the form of a natural conception lubricant. This acquisition is subject to further due diligence and stock exchange approval, and would see the Company issue 20 million shares and agree to pay a 5% royalty on sales. In addition to this pending acquisition, the Company intends to expand into the women’s health market to complement and add to its existing portfolio aimed at obesity.
- An estimated 7.1 million couples in the United States are struggling with infertility
- ToConceive is positioned to capture a percentage of the $3 billion spent annually on assisted reproduction in the U.S.
- ToConceive is FDA cleared, gynecologist discovered and clinically proven
- Average cost of IVF treatment in the U.S. is $13,000
- Cost of three months of ToConceive is $120
- On September 20, 2016 M Pharma announced the final closing of its non-brokered private placement of convertible debentures resulting in a total of $2,013,100 of debentures being issued.
- Proceeds will be used to arrange manufacturing and testing of the Company’s reformulated orlistat drug, starting the regulatory process around the same, and for general administrative expenses.
- M Pharma created a new wholly owned subsidiary, M Pharmaceutical USA Inc. to be the Company’s operating entity for its production, testing and marketing of its C-103 project. This company will operate out of the Greater Cincinnati region.
- The company appointed Mr. Gary Thompson of Fort Thomas, Kentucky to serve as the President of M Pharmaceutical USA Inc. Mr. Thompson will oversee the production, testing and regulatory approval program for the C-103 project.
- M Pharma appointed Mathew Lehman to the company’s Advisory Board. Mr. Lehman served as Chief Executive Officer for M Pharmaceutical Inc., from August 2015 through March 2016. Mr. Lehman is a biopharma industry veteran whose role on the Advisory Board will be focused on the regulatory process for C-103.
- M Pharma. announced findings from three previously completed studies for its C-103 drug technology. FDA research has documented that over 90% of orlistat users have experienced adverse events like fecal incontinence, oily spotting and flatus with discharge. The findings from the three studies conducted demonstrate that the 90% rate of adverse events was significantly reduced to less than 2% when accompanied with the C-103 technology.
- M Pharmaceutical Inc. announced the successful design and engineering of its sequential release dual compartment gelatin capsule, required for the effective delivery of C-103. As the development of C-103 hinged on the engineering of a sophisticated delivery system, this advance represents a significant milestone.
- The new capsule allows for the release of three separate ingredients in a designed sequence while the capsule travels the digestive tract in order to gain the most effective result. In addition the manufacturing techniques and processes will be considered proprietary and offer an additional level of global patent protection.
- The new design means the Company can engage immediately with prospective capsule manufacturing partners in order to advance to clinical trials and commercialization.
- As previously noted, on November 15, 2015, the Canadian Intellectual Property Office allowed patent application 2,720,691, entitled “Bezoar-Forming Units for Weight Control,” to be issued. This patent was filed on April 28, 2009 and will remain in force for 20 years from that date.
- The patent claims cover the design, composition, and methods to use bezoar-forming units that are temporary and dissolvable. This patent is fundamental to the design of M Pharmaceutical’s Trimeo capsules, currently under development for weight loss. This Canadian patent covers substantially the same claims as in United States patent 9,066,877B2, previously issued in June 2015.
- M Pharma’s goals in relation to Trimeo over the next 4-6 months include optimizing production of the capsules and obtaining ISO certification to manufacture and to initiate a definitive proof of concept trial in patients to support the effort to attain a CE mark in Europe and overall to guide the Company in larger, pivotal efficacy trials.
- M Pharma has engaged Camargo Pharmaceutical Services in order to develop the regulatory strategy for the company’s recently acquired patented C-103 reformulation of orlistat.
- Camargo Pharmaceutical Services is an experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes.
- At this exciting and critical stage in the development of C-103, our leadership team and Advisory Board believe it is prudent to engage Camargo’s guidance and expertise.
M Pharma 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.
Our commitment to being a leader in the management of obesity and weight loss is unwavering, 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 Pharma believes its development-stage product has the potential to treat obesity with fewer side effects than 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 and sold by Roche as Xenical® (prescription) and by GlaxoSmithKline as alli® (over-the-counter). Proven safe and effective in over 100 clinical trials1, 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. M Pharma acquired the C-103 assets from Chelatexx, LLC for $200,000 cash, 10 million shares, and a low single-digit royalty. This transaction closed in July, 2016. 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 Pharma estimates peak sales for the product of over $200 million per year.
The Company has been focused on three key measures of success for our products: efficacy, safety, and manufacturing quality. All three of these factors are critical to the development of clinically and commercially successful medical devices. With the addition of key consultants, the Company is committed to the expedited development of these critical success factors.
Brian Keane, President & Chief Executive Officer
M PHARMACEUTICAL INC. INTELLECTUAL PROPERTY BACKGROUND
C-103 is a novel formulation of orlistat
Orlistat is currently marketed in prescription strength by Roche Laboratories, Inc. (Xenical® 120mg capsules) and in over-the-counter strength by GlaxoSmithKline Consumer Healthcare (alli® 60mg capsules). Orlistat has proven safe and effective in numerous clinical trials and remains the only FDA-approved weight management drug for a pediatric population (adolescents 12 years and older). Orlistat does not affect the central nervous system and it is not systemically absorbed, as compared to other approved weight management drugs.
Recent sales of orlistat have declined from its peak due to the well-publicized and uncomfortable side effects of the product. The development goal of the C-103 reformulation is to maintain the proven efficacy of orlistat while minimizing or eliminating the undesirable side effects. The Company now holds issued U.S. patents covering C-103 technology until 2030. The U.S. Food and Drug Administration has confirmed in writing that C-103 is eligible for 505(b)(2) approval in the U.S., under which the FDA is permitted to rely, for approval of the new drug, 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. The Company cautions that there is no guarantee that C-103 will achieve its development goals and that there are no guarantees that C-103 will be approved by any health regulatory agency.
Trimeois an oral capsule containing wrapped, super-absorbable, biodegradable polymers for oral administration. These pill-like devices are swallowed by patients with water and expand in the stomach to induce a feeling of fullness, thereby reducing food intake. Trimeo works in two stages, which differentiates it from other expanding capsules in development. First, as the capsules expand, the polymers stay enclosed in a biodegradable mesh sac which is similar to the sensation your stomach experiences when eating regular food. After a period of time, the sac disintegrates and the polymer particles continue to slow the gastric emptying of food to the small intestines. Prototypes of Trimeo have been tested in a 16-patient pilot trial and demonstrated a 6% reduction in weight and 6.1% reduction in BMI after two months.
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 recent 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 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.”
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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 company’s biomedical & drug technologies, and the acquisition of the rights to a new product. 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 other international regulatory body.