The new worldwide licensing agreement expands a previous one, under which Oscient had rights to the drug in the US and Canada only. Oscient will now assume full control of Ramoplanin manufacturing, development and commercialization on a global basis.
Oscient recently agreed on a special protocol assessment (SPA) with the FDA for the phase III program of Ramoplanin.
“Acquiring worldwide rights to Ramoplanin is a major milestone for Oscient,” stated Steven Rauscher, president and CEO of Oscient Pharmaceuticals. “With full ownership of Ramoplanin, we have significantly strengthened our asset portfolio and, after securing a long-term source of product supply, will be poised to advance the product candidate into phase III development.”
In exchange for the expanded worldwide rights, Oscient has made a one-time, up-front payment to Pfizer, and will make additional payments upon the achievement of specified regulatory milestones and for royalties on net sales. Pfizer has agreed to transfer the technological know-how related to the manufacture of Ramoplanin.