Ampio Pharmaceuticals, Inc. (Ampio), has received notification from European Patent Office that 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).

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.

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 per cent 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."

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."

Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction.