Baxter International and ScinoPharm Taiwan announced a strategic partnership yesterday to develop, manufacture and commercialise an initial five oncology drugs, with scope for an additional 15 injectable molecules.
“The collaboration with ScinoPharm represents a rare and compelling opportunity to partner with one of the world’s leading active pharmaceutical ingredient [API] manufacturers with a 17-year history of quality and safety serving the global pharmaceutical industry,” a spokesperson from Baxter told in-Pharmatechnologist.com.
“Current branded sales of the initial five products included in this partnership total more than $4bn annually. Baxter is not disclosing specific cost details associated with this partnership.”
Manufacturing
Manufacturing will be carried out at both Baxter’s facility in Halle, Germany and Scinopharm’s injectable plant in Tainan, Taiwan.
A Scinopharm spokesperson added the latter will be ready for registration batch production by 2017, with the first in-house ANDA submission from the partnership set for 2018, and a subsequent US FDA inspection approval expected in 2019.
“ScinoPharm will be responsible for raw material sourcing for all APIs and the injectables made in-house by ourselves,” Scinopharm told us. “Baxter will be responsible for raw material sourcing for the injectables made by themselves.”
Scinopharm invested NT$1.1bn ($36m) into its Tainan site in 2012 to build a high potency cytotoxic injectable plant, and as such does not need to add new capacity or staff to service this collaboration, we were told.