Cincinnati, Ohio (June 2, 2017)
M Pharmaceutical Inc. (CSE:MQ, OTCQB: MPHMF, FWB:T3F2 ), (the “Company” or “M Pharma”), is pleased to announce that it has engaged Camargo Pharmaceutical Services, in order to help advance a drug development strategy for the Company’s recently patented Extrinsa product for Female Sexual Dysfunction (FSD).
Known for their experience and expertise in 505(b)(2) drug development, Camargo Pharmaceutical Services provides guidance to navigate the complex regulatory landscape via the most time and cost-effective path forward. Camargo ensures FDA buy-in, and aligns complete development plans with business strategies. Camargo routinely leads up to 6 meetings with the FDA per month, has guided more than 200 FDA approvals, and works with product developers from more than 25 countries.
“At this exciting and critical stage in the development of Extrinsa, our leadership team believes it is prudent and necessary to benefit from Camargo’s years of expertise guiding new drugs through the FDA approval process. This alliance of M Pharma and Camargo Pharmaceutical Services will strengthen our effort and expedite the process to bring Extrinsa to market, benefitting millions of women suffering from female sexual dysfunction,” said Mr. Thompson, President & CEO of M Pharma.
“At Camargo, our purpose is to use our 505(b)(2) expertise to guide our clients and their drugs along the most efficient and effective development path possible, in order for them to achieve commercial success,” said Ken Phelps, President and CEO of Camargo Pharmaceutical Services. “We look forward to working with M Pharma to advance this new program in their portfolio.”
Unlike the other two drugs approved by the US FDA to treat FSD, the company’s topical drug product, Extrinsa, would focus on women with orgasm and arousal difficulties. Valeant’s Addyi, recently acquired from Sprout Pharmaceuticals, is indicated only for HSDD (desire disorder) with a number of FDA imposed prescription and marketing restrictions. Intrarosa, by Endoceutics, is indicated for dyspareunia (pain with intercourse) with certain prescribing restrictions. M Pharma’s Extrinsa treatment is topical, local and non-systemic, with daily and on demand use, while being non-hormonal and not a central nervous system drug. Based on these core attributes, the safety profiles of the API and excipients in the drug product, and the dosage and delivery form, the company anticipates Extrinsa to be extremely well-tolerated and highly effective for many women suffering from FSD and has a great likelihood of ultimate approval by the FDA.
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.