Shares in drugs developer M Pharmaceutical Inc (CSNX:MQ, OTCMKTS:MPHMF) raced up 20% in Toronto as it updated on what has been a transformative year for the company, ahead of a corporate rebranding in the near future.
M Pharma has in the year expanded its treatment portfolio, added significant revenue to the bottom line and received FDA pathway approval for its C-103 - reformulated Orlistat- project, chief executive Gary Thompson said in letter to shareholders.
What does it do and what are the assets?
The firm's focus is on treatments for obesity, weight management, and female health. In addition to its recent acquisitions of C-103, a reformulation of slimming product Orlistat and assets from 40J's, the company is scheduled to launch its FDA cleared fertility product branded as 'ToConceive' in the third quarter of 2017.
Increasing production levels..
As part of its previous acquisition of the assets of Cincinnati-based 40J's LLC, the group bought an active contract for its female intimacy gel.
The partnership associated with that contract has now increased production levels of the gel by 50%, the group said, and is committed to expanding the distribution portfolio with up to four additional M Pharma products, with an anticipated release date before the end of 2017.
The 40J's deal gave the group new assets, which included current quarterly distribution revenues of around $170,000, along with eight patented and patent pending pipeline technologies, one of which is the new drug Extrinsa for female sexual dysfunction, which has a market opportunity estimated at $1bn a year
Significantly, M Pharma said it was now in talks with new distribution partners for these pipeline products in the Middle East, EU, Pacific Rim, Brazil and North America.
A launch for ToConceive..
And as reported yesterday, the group expects to launch its fertility product 'ToConceive' the North American market this September, after it was pushed back due to FDA regulatory requirements.
A two-month advance marketing strategy has been developed and begins this month, while net revenues for ToConceive are expected to be $160,000 per month.
Orlistat business plan underway..
Meanwhile, on its C-103 reformulated Orlistat slimming product, the group has received a positive response from its pre-IND (investigational new drug) filing with the FDA and now has a clear 505(b)(2) pathway defined.
A business plan development is currently underway to outline potential JV opportunities to drive pivotal clinical trials.
M Pharma is targeting $500mln in the US market alone as first year revenues for Orlistat, once it is approved by the FDA.
"M Pharma today is a much different company from M Pharma just one year ago. We believe that this new company with a new product portfolio and revived vitality deserved a refreshed public identity," Thompson said.
"A public identity that reflected our mission to offer our customer's realistic solutions based on the principles of reduced invasiveness and enhanced effectiveness. Plans are in place to announce our new corporate name, logo and website in the very near future."