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Ampio Pharmaceuticals' Zertane™ Patent Estate Bolstered by Two New European Patents

Zertane™ in combination with erectile dysfunction drugs opens new partnering opportunities


News provided by

Ampio Pharmaceuticals, Inc.

Jan 17, 2012, 07:00 ET

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GREENWOOD VILLAGE, Colo., Jan. 17, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced notification by the European Patent Office they will be awarded two new patents in Europe for the combination of Zertane™ (Ampio's premature ejaculation (PE) drug) with any erectile dysfunction (ED) drug of the PDE5 inhibitors family such as sildenafil, tadalafil and the likes and for a combination of Zertane™ with compounds that reduce the side effects of tramadol (the active ingredient of Zertane™).

Dr. David Bar-Or, Ampio's Chief Scientific Officer, noted, "These patents complement the already worldwide issued patents of the use of Zertane™ in any dose for the treatment of premature ejaculation in males and include composition of matter claims. The coexistence of ED and PE is a significant sexual problem, as up to 30% of males treated for ED also suffer from PE. The granting of these patents is an important milestone in the company's strategy to license and commercialize its sexual dysfunction drugs."

Business Strategy for Sexual Dysfunction Drugs:

Ampio CEO Michael Macaluso noted, "We believe there will be significant interest in a combination therapy that addresses both PE and ED, due to the fact there are no therapies available for the men who experience both. Pharmaceutical companies, currently providing PDE5 inhibitor drugs to treat only ED, and facing expiration of their patent protection, 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. We will seek an appropriate partner to bring our product to market as expeditiously as possible."

About Zertane™ 

Zertane™ is an 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. 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 Ampio Pharmaceuticals

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.

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 involve risks and uncertainties, such as 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:
Investor Relations
 Ampio Pharmaceuticals, Inc.
 720-437-6500

SOURCE Ampio Pharmaceuticals, Inc.

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