12:29:04 EDT Tue 30 Apr 2024
Enter Symbol
or Name
USA
CA



M Pharmaceutical Inc (2)
Symbol MQ
Shares Issued 110,540,814
Close 2017-02-09 C$ 0.055
Market Cap C$ 6,079,745
Recent Sedar Documents

M Pharma expects orlistat response from FDA March 6

2017-02-10 06:19 ET - Shareholders Letter

Mr. Gary Thompson reports

M PHARMACEUTICAL INC. PROVIDES STRATEGIC REPORT TO SHAREHOLDERS HIGHLIGHTING ACQUISITIONS AND PRODUCT DEVELOPMENT

M Pharmaceutical 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.

C-103

  • With significant assistance from Camargo Pharmaceutical Services the PIND (preinvestigational new drug) meeting package for our reformulated orlistat (C-103) has been completed and delivered to the FDA (Food and Drug Administration) investigator.
  • The FDA is scheduled to respond to our PIND package by March 6, 2017. Once we incorporate its recommended adjustments, we should have an approved path including particulate partners and study requirements.
  • The USPTO (U.S. Patent and Trademark Office) 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 its questions on Jan. 26, 2017, and should have an update some time in March, 2017. This patent is not required to commercialize C-103, but would provide an additional level of patent protection.

ToConceive

  • We suspended sales of ToConceive in December and contracted with Anstice Communications out of Calgary to develop and execute on a rebrand/rebuild strategy.
  • M Pharma purchased the website domain for ToConceive.
  • The Anstice team has performed competition analysis, held several focus group discussions, on-line surveys, and interviewed past customers and key stakeholders.
  • Development of the new website is under way based on the results of our customer research.
  • A strategic brief and brand model presentation is scheduled for Feb. 14, 2017.
  • Reformulation of the product to be parabens free is complete and ready for production. Once a brand (look, size, price) has been approved, inventory can be established.
  • On-line 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 its services to advance this product through the FDA approval process via the 505(b) (2) pathway, similar to our C-103 project.

Paralt

  • The original paraben-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 and L-arginine patented technology

The foundation for most of 40J's products is based on the patented and FDA-cleared topical gel combining menthol and 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 40J's of approximately $800,000 (U.S.) per year.

Other business development opportunities (transfer pricing, private labelling and licensing) for many of these products have been identified in the United States, Canada, the European Union, Middle East, Asia and South America. These products provide us significant opportunities and some are listed below.

  1. Arousal gels;
  2. Phytoestrogen gels;
  3. Breast enlargement creams;
  4. Male enhancement gels;
  5. Lip plumper gels;
  6. Diabetic neuropathy treatment gels;
  7. Oral THC/CBD (tetrahydrocannabinol/cannabidiol).

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.

Sincerely,

Gary Thompson,

President and chief executive officer,

M Pharmaceutical USA Inc.

About M Pharmaceutical Inc.

Formed in early 2015, 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. 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.

We seek Safe Harbor.

© 2024 Canjex Publishing Ltd. All rights reserved.