GREENWOOD VILLAGE, Colo.
, July 2, 2012
/PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion, Optina & Zertane
), licensing distribution of these drugs and developing additional new drugs, today announced that it 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."
Syngene is an internationally reputed contract research and manufacturing organization with multidisciplinary skills in chemistry and biology services. From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized services to pharmaceutical and biotechnology majors, on a strong platform of confidentiality and intellectual property protection.
Zertane is a repurposed oral drug to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient in Zertane has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use for other medical indications. These unique pharmaceutical qualities, exceptional human safety record, and a distinctive non-standard dosage not available in generic form, differentiate Zertane from other treatments for premature ejaculation. Zertane is taken as needed before sexual activity, and is not required on a daily basis
Zertane-ED addresses a significant clinical need as up to 30% of males treated for PE also suffer from ED and there are currently no therapies available for the men who experience both. Nearly all pharmaceutical companies, currently providing PDE5 inhibitor drugs to treat only ED are facing near term expiration of their patent protection and may find our combination drug to be an attractive means of significantly extending and upgrading their franchise in this large and rapidly growing clinical field.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs"). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
*McMahon CB, Althof SE, Waldinger MD, Porst H, Dean J, et. al. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation. J Sex Med. 2008 July; 5 (7): 1590-606.
Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, successful commercialization and marketing of Zertane and the combination drug in Korea, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Contact:Rick Giles, Investor Relations, Ampio Pharmaceuticals, Inc. 720-437-6500
SOURCE Ampio Pharmaceuticals, Inc.