ScinoPharm (TWSE:1789) announced today that its Tainan, Taiwan Facility will provide commercial manufacturing of topiramate active pharmaceutical ingredient ("API") for VIVUS' Qsymia™, a new drug for the treatment of obesity approved by the United States Food and Drug Administration on July 17, 2012.
Qsymia™ is the first FDA-approved once daily combination treatment for chronic weight management in adults who are obese or overweight with a weight-related comorbidity. It is a combination of an anticonvulsant, topiramate, and appetite suppressant, phentermine. Clinical studies showed that Qsymia™ can effectively assist in weight management.
"ScinoPharm is proud of our longstanding partnership with VIVUS, which began with the supply of topiramate for the Qsymia™ clinical development program. We are committed to providing VIVUS and our other customers with high quality APIs, ensuring fast time-to-market," remarked Dr. Jo Shen, President and CEO of ScinoPharm.
Topiramate is an active pharmaceutical ingredient that ScinoPharm began commercial production two years ago for the treatment of epilepsy and other nervous system disorders as a generic API. With this approval for weight management, the market potential for topiramate is expected to increase substantially.
ScinoPharm partners with other leading pharmaceutical companies for industrial manufacturing of new and existing drugs. With CGMP-compliant facilities at gram to ton scales, ScinoPharm has worked on over 70 new chemical entity projects with 4 new drugs (including Qsymia™) already approved by the US FDA and 5 more entering Phase III clinical trials.
ScinoPharm is currently expanding its manufacturing and process development capabilities through its new Mainland China facility in Changshu, which will initially be used for the production of pharmaceutical intermediates with CGMP-grade API production planned for the near future. This expansion allows ScinoPharm to further support customer needs with a wide range of cost-effective contract manufacturing services for clinical, small-scale, and commercial-stage APIs and intermediates.