Cincinnati, Ohio (May 31, 2017)
M Pharmaceutical Inc. (CSE: MQ, OTCQB: MPHMF, FWB: T3F2), (the “Company” or “M Pharma”), a clinical-stage company developing innovative technologies for weight management and female health & wellness, today announced that with the assistance of Camargo Pharmaceutical Services (“Camargo”), it received a successful response from the US Food and Drug Administration (FDA) of its clinical study plan through the 505(b)(2) pathway for the company’s obesity management drug, C-103, reformulated Orlistat.
“The FDA’s swift and definitive written response to our Pre-IND submission package provides M Pharma with significant optimism for immediately pushing forward with our plans to initiate clinical trials in 2017,” noted Mr. Gary Thompson, President and CEO of M Pharma.
“At this exciting and critical stage in the development of C-103, our leadership team and advisory board believe it is prudent and necessary to benefit from Camargo Pharmaceutical ’s guidance and expertise. This alliance strengthens our efforts to bring C-103 to market, benefitting millions of potential people looking for solutions to reach and maintain a healthy weight,” said Thompson.
“Helping our clients achieve success at the Pre-IND stage means gaining alignment with the Agency on a clear development plan moving forward,” says Ken Phelps, President and CEO of Camargo Pharmaceutical Services. “We are looking forward to assisting M Pharma in leveraging the successful Pre-IND meeting results and executing a clear path forward by initiating the clinical plan starting this year.”
About C-103, reformulated Orlistat
Orlistat is currently marketed in prescription strength by Roche Laboratories, Inc. (Xenical® 120mg capsules) and in OTC 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 uncomfortable and well-publicized 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. M Pharma 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.
About Callitas Therapeutics
Formerly M Pharmaceutical Inc., Callitas Therapeutics was formed in early 2015, 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 from Chelatexx, LLC and assets from 40J’s LLC including Extrinsa, the Company is scheduled to launch their FDA cleared fertility product branded as ToConceive in July of this year.
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.”
For more information contact:
Phone: +1 (859) 868-3131
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.
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.
Notice regarding investigational drugs: 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.