Published on September 12, 2012 at 5:22 AM
Ampio Pharmaceuticals, Inc. (AMPE), a clinical stage biopharmaceutical company, with repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction announced today that it has entered into a definitive agreement with Ethypharm Ltd for the manufacturing of Zertane™, Ampio's drug for the treatment of premature ejaculation. Zertane™ is a specially formulated orally disintegrating tablet (ODT) manufactured by Ethypharm under patented processes jointly owned by Ethypharm and Ampio. (Ampio acquired the ODT formulation technology from Valeant in December of 2011).
This agreement and the manufactured drug will be used to:
SOURCE Ampio Pharmaceuticals, Inc.
- Complete the IND for the conduct of pivotal trials of Zertane™ in the USA as agreed with the FDA. This includes the delivery of the final packaged drug as well as all documentation necessary for registration and approval processes with the FDA and other regulatory agencies.
- Complete the registration package for approval of Zertane™ by the TGA in Australia (based on the completed phase 3 trials conducted in Europe), which will be used for approval in multiple countries, including South Korea and Brazil where Ampio has secured licensing agreements.
- Finalize pricing of Zertane™ for launch in countries outside the USA and provide clarity for licensing negotiations with additional potential partners.