The US Food and Drug Administration (FDA) cleared Qsymia (phentermine and topiramate extended-release) for obese patients who have a weight-related condition this week, just days after approving a similar drug – Belviq – developed by Arena Pharmaceuticals and Eisai.
But while Arena plans to produce its product in-house at a facility in Switzerland, Vivus has called on contract manufacturing organisation (CMO) ScinoPharm to supply the active pharmaceutical ingredient (API) for Qsymia, topiramate.
ScinoPharm has been producing topiramate – which is a generic API approved for the treatment of epilepsy and other nervous system disorders - its facility in Tainan, Taiwan for the last two years.
The CMO also made supplies of the API to support the clinical development of Qsymia as an obesity treatment on Vivus’ behalf.
Manufacturing capacity
News of the deal coincides with ScinoPharm's efforts to increase the amount of APIs it can produce. The firm told Outsourcing-pharma.com that: "In order to accommodate the rapid growth in production orders, we have undertaken major steps toward capacity expansion.
"Two large production lines under construction are for overall capacity needed, not specifically for topiramate alone," ScinoPharm explained adding that these are expected to be operational sometime in Q4.
ScinoPharm also plans to hire additional production staff, but again this is in response to general growing demand rather than topiramate specifically.
Wu declined to say how much revenue ScinoPharma expects the Vivus contract to generate citing the CMO's status as a public company.
The news also follows just a few weeks after SinoPharm announced plans to expand capacity at its Tainan plant in a move designed to boost its high-potency APIs for injectable drugs.
ScinoPharm is also ramping up pharmaceutical intermediate and API production capacity at its facility in Changshu, China.