M Pharma plans JV to develop reformulated orlistat
2017-06-30 06:24 ET - News Release
Mr. Gary Thompson reports
M PHARMACEUTICAL TO PARTNER ON DEVELOPING JOINT VENTURE STRATEGY FOR RE-FORMULATED ORLISTAT WEIGHT LOSS DRUG C-103
M Pharmaceutical Inc. will be pursuing a joint venture or strategic alliance for the development of its C-103 reformulated orlistat drug product. M Pharma recently announced a successful response to a pre-IND (investigational new drug) meeting response letter and package from the U.S. Food and Drug Administration (FDA) for the definitive clinical development plan through the 505(b)(2) pathway, under which the FDA is permitted to rely 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.
"Now that we have a positive response from the FDA in hand, our plans for the development of C-103 are advancing quickly," said Gary Thompson, president and chief executive officer of M Pharmaceutical. "These plans include establishing a joint venture or strategic alliance with the appropriate partner who has the financial resources, drug development experience and an existing distribution infrastructure required for C-103 to global commercialization," said Mr. Thompson.
C-103 and orlistat background information
The development goal for the C-103 drug product is to maintain the proven efficacy of orlistat for weight reduction or weight maintenance while minimizing or eliminating the undesirable adverse events (underwear issues) experienced by millions of patients. M Pharma holds issued U.S. patents covering C-103 technology until 2030.
Orlistat monotherapy is currently approved as a prescription product, under NDA 020766 (Xenical capsules, 120 milligrams) and as an over-the-counter (OTC) drug, under NDA 021887 (Alli capsules, 60 mg). Xenical is indicated as a treatment for obesity management, including weight loss and weight maintenance in conjunction with a reduced-calorie and low-fat diet; for individuals with a BMI (body mass index) of 30 or greater (obese); or 27 or greater (overweight) in the presence of at least one weight-related comorbid condition (that is, hypertension, dyslipidemia, Type 2 diabetes). Orlistat has been proven safe and effective in numerous clinical trials and remains the only FDA-approved weight management drug for the adolescent population (12 years and older). Orlistat, unlike all the other branded and generic prescription drugs for obesity, does not affect the central nervous system and it is not systemically absorbed. Recent sales of orlistat have declined from its peak due to uncomfortable and well-publicized adverse event of the product.
About the U.S. obesity market
Today 38 per cent of American adults over 20 and 17.2 per cent of children over age seven are obese in the United States, and an additional 30 per cent are classified as overweight. The annual health cost related to obesity in the U.S. is nearly $200-billion, and nearly 21 per cent of all medical cost in the U.S. can be attributed to obesity.
About M Pharmaceutical Inc.
Formed in early 2015, M Pharmaceutical is a clinical-stage company developing innovative technologies for obesity, weight management, and female health and 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 its FDA-cleared fertility product branded as ToConceive some time in the third quarter of 2017.
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