M Pharmaceutical Inc (CNQ:MQ, CNSX:MQ) said on Tuesday it has engaged Camargo Pharmaceutical Services in order to help develop a drug development strategy for the company’s recently acquired patented Chelatexx technology, known as its C-103 reformulation of Orlistat.
C-103 is a novel formulation of Orlistat, patented until 2030 in the United States. Orlistat is Food and Drug Administration-approved for weight management and sold by Roche as Xenical (prescription) and by GlaxoSmithKline as alli (over the counter).
Orlistat is the best-selling weight-loss medication of all time with peak sales over $900mln in 2007. C-103 is intended to maintain the efficacy of Orlistat while minimizing its socially unacceptable side effects.
Known for its 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 six meetings with the FDA per month, has guided more than 200 FDA approvals and works with product developers from more than 25 countries.
“At Camargo, we focus on providing guidance through all aspects of drug development, ensuring our client-partners’ programs advance through the regulatory process, gain approval and commercial success,” said Dr. Ruth Stevens, chief scientific officer and executive vice-president of Camargo Pharmaceutical Services.
“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’s guidance and expertise. This alliance will strengthen our effort and expedite the process to bring C-103 to market, benefiting millions of potential people looking for solutions to reach and maintain a healthy weight,” said Brian Keane, president and chief executive officer of the company.
Story by ProactiveInvestors