Vernalis will pay Paul Capital Healthcare 90% of fees earned from Menarini on treatment, which is already marketed for migraines.
Vernalis will receive approximately €18.4 million in cash from Paul Capital Healthcare to address the potential of a label extension on its migraine drug, frovatriptan, to include menstrual migraine. In return, Paul Capital Healthcare will take about 90% of payments that Vernalis receives from Menarini under their agreement related to European sales of this compound, which is approved for migraine.
Frovatriptan is marketed under the name Frova® as a migraine drug. While Vernalis copromotes the therapy in North America with Endo Pharmaceuticals, Menarini owns related rights in certain European countries. Vernalis supplies Menarini with the API and earns royalties on sales.
Vernalis and Endo are evaluating the best strategy to respond to the FDA’s letter asking for additional information on frovatriptan to allow approval in the menstrual migraine indication. Endo filed an sNDA in July 2006 and received an Action Letter in September 2007.