Ampio (AMPE) Will Proceed with Zertane Development Following Positive Pre-IND Meetings
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Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), is proceeding with the development plan for a combination product to treat both premature ejaculation (PE) and erectile dysfunction (ED). The positive pre-IND meeting in June with the FDA gave the company clear guidance for the two concurrent pivotal trials necessary for approval of Zertane to treat PE in the USA.
Vaughan Clift, MD, Ampio's Chief Regulatory Officer, noted "Contrary to rumors that the FDA did not recognize PE as a treatable ailment, the FDA has expressly adopted the definition of PE as a disease condition, using the definition of Premature Ejaculation provided by the International Society for Sexual Medicine (ISSM) Ad Hoc Committee (i.e., premature ejaculation is characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.*) This definition fully complements and encompasses the clinical results from its successful Phase 3 studies of Zertane™ conducted in Europe which was reported in the prestigious journal European Urology."
Michael Macaluso, Ampio's CEO added "The clear clinical path for Zertane™ provided by the FDA, and the reasonable costs to complete these PE trials, allows Ampio to present potential distribution partners a portfolio of sexual dysfunction drugs that treat both PE and the PE/ED combination worldwide. Ampio was recently awarded multiple patents worldwide for combinations of Zertane™ with any PDE5 inhibitors and for reduction of side effects of Tramadol. These recently awarded patents will benefit from a full patent life and are important for negotiations with potential partners whose PDE5 inhibitors patent protection has expired or are about to expire which could be greatly extended by Ampio's patents."
Mr. Macaluso continued "As a first step for the clinical study of Zertane-ED™, Ampio entered into an agreement with Syngene (Bangalore, India) to begin manufacturing (in compliance with FDA standards) the combo product for the conduct of a phase III trial for these co-morbid conditions in South Korea by our partner Daewoong Co. Ltd. By previous contractual agreement Daewoong will finance and conduct the South Korean phase III trial according to FDA standards/guidelines and the data generated will be used both for approval in South Korea and to support an FDA submission. This agreement with Syngene will accelerate the initiation of the phase III trial in South Korea."
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Vaughan Clift, MD, Ampio's Chief Regulatory Officer, noted "Contrary to rumors that the FDA did not recognize PE as a treatable ailment, the FDA has expressly adopted the definition of PE as a disease condition, using the definition of Premature Ejaculation provided by the International Society for Sexual Medicine (ISSM) Ad Hoc Committee (i.e., premature ejaculation is characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.*) This definition fully complements and encompasses the clinical results from its successful Phase 3 studies of Zertane™ conducted in Europe which was reported in the prestigious journal European Urology."
Michael Macaluso, Ampio's CEO added "The clear clinical path for Zertane™ provided by the FDA, and the reasonable costs to complete these PE trials, allows Ampio to present potential distribution partners a portfolio of sexual dysfunction drugs that treat both PE and the PE/ED combination worldwide. Ampio was recently awarded multiple patents worldwide for combinations of Zertane™ with any PDE5 inhibitors and for reduction of side effects of Tramadol. These recently awarded patents will benefit from a full patent life and are important for negotiations with potential partners whose PDE5 inhibitors patent protection has expired or are about to expire which could be greatly extended by Ampio's patents."
Mr. Macaluso continued "As a first step for the clinical study of Zertane-ED™, Ampio entered into an agreement with Syngene (Bangalore, India) to begin manufacturing (in compliance with FDA standards) the combo product for the conduct of a phase III trial for these co-morbid conditions in South Korea by our partner Daewoong Co. Ltd. By previous contractual agreement Daewoong will finance and conduct the South Korean phase III trial according to FDA standards/guidelines and the data generated will be used both for approval in South Korea and to support an FDA submission. This agreement with Syngene will accelerate the initiation of the phase III trial in South Korea."
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