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News Breaks | | | | September 12, 2012 | | 05:59 EDT |  | AMPE | Ampio provides update of manufacturing plans for Zertane
Ampio Pharmaceuticals announced 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 manufactured by Ethypharm under patented processes jointly owned by Ethypharm and Ampio. The agreement and the manufactured drug will be used to: Complete the IND for the conduct of pivotal trials of Zertane in the USA as agreed with the FDA; Complete the registration package for approval of Zertane by the TGA in Australia, 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. | |
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