VANCOUVER, B.C., CANADA (February 10, 2017) - M Pharmaceutical Inc. (CSE: MQ, OTCQB: MPHMF, FWB: T3F2), (the "Company" or “M Pharma”) Mr. Gary Thompson, President and CEO of M Pharmaceutical USA Inc., has issued a comprehensive update letter to shareholders.
Dear Shareholders of M Pharma:
I am pleased to provide this update to shareholders regarding our growth initiatives as they relate to the Company’s market prospects and enhancement of value to our shareholders. Since July, 2016, the Company has seen significant corporate development, adding to its C-103 project by acquiring the global marketing rights to ToConceive in November, 2016 and entering into a Letter of Intent with Cincinnati based 40J’s LLP. Definitive documents for the 40J’s acquisition are currently being reviewed by attorneys with signing and closing anticipated by mid-February. This report assumes a successful 40J’s closing and includes updates on those assets.
- With significant assistance from Camargo Pharmaceutical Services the PIND meeting package for our reformulated Orlistat (C-103) has been completed and delivered to the FDA investigator.
- The FDA is scheduled to respond to our PIND package by March 6,2017. Once we incorporate their recommended adjustments, we should have an approved path including particulate partners and study requirements.
- The USPTO has issued an Office Action on the patent application for the “Dual Compartment Capsule for the Administration of Orlistat”. This is a common occurrence with applications. We responded to their questions on January 26, 2017 and should have an update sometime in March, 2017. This patent is not required to commercialize C-103, but would provide an additional level of patent protection.
- We suspended sales of ToConceive in December and contracted with Anstice Communications out of Calgary to develop and execute on a “Re-brand/Re-build” strategy.
- M Pharma purchased the website domain www.toconceive.com.
- The Anstice team has performed competition analysis, held several focus group discussions, online surveys and interviewed past customers and key stakeholders.
- Development of the new website is underway based on the results of our customer research.
- A Strategic Brief and Brand Model presentation is scheduled for February 14, 2017.
- Re-formulation of the product to be parabens free is complete and ready for production. Once a brand (look, size, price, etc) has been approved, inventory can be established.
- Online sales should launch in late April or May, 2017 with targeted sales of 2,000 units per month initially.
Female Sexual Dysfunction drug
- The original FSD Provisional patent application was submitted to the USPTO in April, 2015.
- The Non-Provisional patent application was submitted to the USPTO in April, 2016.
- Office Action was received from the USPTO in September, 2016 with a response submitted in October, 2016.
- We anticipate hearing from the USPTO by May, 2017.
- Camargo Pharmaceutical Services has been notified of our plans to engage their services to advance this product through the FDA approval process via the 505(b) (2) pathway, similar to our C-103 project.
- The original parabens free patent application was submitted to the USPTO in March, 2015.
- The Non-Provisional patent application was submitted in May, 2016.
- The USPTO patent response is expected by May, 2017
- If we are not granted an application, we are still allowed to use the technology and list all of our products as ‘parabens free.’
- If our patent is granted, we have a technology we can out license to other drug manufacturers.
Menthol & L-arginine patented technology
The foundation for most of the 40J’s products is based on the patented and FDA cleared topical gel combining Menthol & L-arginine. This innovative formulation can be paired with many different ingredients to address a multitude of medical issues.
Some of these products are currently distributed in China through an agreement with a third party, with current revenues to 40 Js of approximately US $800,000 per year.
Other business development opportunities (transfer pricing, private labeling & licensing) for many of these products have been identified in the US, Canada, the EU, Middle East, Asia and South America. These products provide us significant opportunities and some are listed below.
- Arousal Gels
- Phytoestrogen Gels
- Breast Enlargement Creams
- Male Enhancement Gels
- Lip Plumper Gels
- Diabetic Neuropathy Treatment Gels
- Oral THC/CBD
Our Company has two separate product lines - acquiring and marketing treatments for weight loss and the women’s health space including infertility and improved intimacy. Our objective is to offer the end user realistic solutions based on the principles of reduced invasiveness and enhanced effectiveness. We have advanced our mandate over the past two quarters by expanding and diversifying our treatment portfolio within our focus areas and accelerating the approval process with the FDA. Thank you for the opportunity to update you on the Company’s growth initiatives.
Mr. Gary Thompson
President & Chief Executive Officer
M Pharmaceutical USA 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.”
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 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.