CINCINNATI, OH / ACCESSWIRE / July 18, 2017 / M Pharmaceutical Inc. (CNSX: MQ, OTCQB: MPHMF, FSE: T3F2), (the ”Company” or ”M Pharma”), a clinical-stage company developing innovative technologies for weight management and female health and wellness announced today that it has taken important steps to draft and file a Pre Investigational New Drug (PIND) Meeting Request and Package to the US FDA for our Extrinsa™ topical drug product. With significant assistance from Camargo Pharmaceutical Services, submission should be made in the next 7 business days to the FDA, with a written response or face-to-face meeting expected in 60 days or less.
”The PIND Meeting Request Letter and Package Submission and subsequent Meeting Response Letter from the FDA for the C-103 development project gave us a very clear path to the requirements that must be met for approval of the C-103 drug product; we are hoping for the same level of response and clarity from the FDA for Extrinsa™,” said James Thompson, Chief Operating Officer of M Pharmaceutical USA Inc. ”Once we have a face-to-face meeting with the FDA staff or receive and incorporate their recommended adjustments from a written response letter, we should have clearly defined requirements for a path to drug approval and market in the US.”
Camargo Pharmaceutical Services has been engaged to advance our Extrinsa™ drug product through the FDA approval process via the 505(b) (2) pathway, similar to our C-103 project. They have already delivered a thorough GAP Analysis Report, outlining the tentative approval pathway, clinical and development requirements as well as initial cost estimates involved for the drug development program through NDA submission with US FDA.
Extrinsa™ is a topical form of the prescription drug Tadalafil (sold as Cialis as a men’s ED therapy). Our drug product is being developed and investigated as a possible prescription treatment for Female Sexual Arousal Disorder (primary indication); with a possible second indication for Female Sexual Orgasmic Disorder.
About Camargo Pharmaceutical Services
Camargo has established an unrivaled track record of drug development utilizing the 505(b)(2) pathway and the global equivalent processes. Experts at Camargo have participated in more than 1,100 Agency meetings, resulting in over 200 drug approvals. The Company has more than 30 PhDs with expertise in drug development, including comprehensive in-house specializations of pharmacokinetics; toxicology; and Chemistry, Manufacturing, and Controls (CMC), with offices in Durham, North Carolina, and Cincinnati, Ohio. To learn more about Camargo Pharmaceutical Services, please visit http://camargopharma.com.
About M Pharmaceutical
Formed in early 2015, M Pharmaceutical Inc. is a clinical-stage company developing innovative technologies for obesity, weight management and Female Health & Wellness. In addition to its recent acquisitions of C-103, a reformulation of Orlistat and assets from 40J’s LLC, the Company is scheduled to launch their FDA cleared fertility product branded as ToConceive in September of 2017.
M Pharmaceutical Inc. 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:
Mr. Gary A. Thompson
President and Chief Executive Officer
M Pharma Investor Relations
Phone: +1 (859) 868-3131
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 Extrinsa 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.
SOURCE: M Pharmaceutical Inc.