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Ampio Contracts With Syngene To Manufacture Zertane-ED™, Its Recently Patented Combination Drug To Treat Both Premature Ejaculation (PE) And Erectile Dysfunction (ED)

About Zertane™

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

About Zertane-ED

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.

About Ampio

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.  

Forward-Looking Statements

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.

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