The deal – financial terms of which have not been disclosed – will see the Taiwan-based API maker supply Raffles with the active pharmaceutical ingredient (API) from its plant in Changshu, China in return for a share of the profits from US sales.
A ScinoPharm spokesperson told us Raffles plans to submit the drug master file (DMF) next year and is aiming to launch the product in the US by 2018. She added that, if all goes to plan, ScinoPharm will supply 12 to 15 metric tonnes of the API per month.
The Changshu site has been operational since 2013 and is the cornerstone of ScinoPharm’s efforts to build its customer base in China. The facility complies with China Food and Drug Administration (CFDA) GMP regulations.
But despite being operational for two years, the Changshu site has not made APIs for the US market according to Scinopharm’s spokesperson who told us “Since Changshu is still waiting for FDA inspection; the current utilization rate of large-scale API production lines is low.”
However, she stressed that, if approved by the US FDA, the facility will be up to the task, explaining that: “The celecoxib process is very efficient so our throughput of making this API is high” and adding “there is no capacity issue.”
In addition to generic drugs, Huizhou, Guangdong-headquartered Raffles develops organic macromolecule catalysts, pharmaceutical intermediates and APIs. Under the agreement Raffles will lead R&D efforts.
The deal is likely to be the first of several contracts according to ScinoPharm’s spokesperson who said: “We are working with Raffles for the collaboration of more projects.”
US sales of celecoxib, including the Pfizer originator Celebrex, were $2.6bn (€2.2bn) in 2014 according to data from IMS Health.
If approved, the Scinopharm and Raffles product will be competing for a share of the market with generic versions launched by Actavis, Mylan and Teva last year.