The agreement covers three abbreviated new drug applications (ANDAs) Spectrum has already had approved by the FDA, and a further nine currently under review. The contract also covers additional ANDAs under development.
Spectrum will receive certain milestone payments on achievement of specified regulatory approvals, thought to be worth over $10 million, and the parties will share profits resulting from the sale of the generic products. In addition, Par shall provide financial and legal support for the ongoing patent challenge for sumatriptan injection, a migraine treatment originally developed by GlaxoSmithKline.
“I believe our complementary skills and experience will enhance and expedite the development of our generics program, including what we hope will be a successful paragraph IV challenge for sumatriptan injection,” said Dr Rajesh Shrotriya, chairman, CEO and president of Spectrum.
Par has also agreed to make an equity investment in Spectrum during the next 24 months, at Spectrum’s request. Additional terms of the agreement were not disclosed.