Ampio Pharmaceuticals Announces The Licensing Of Zertane⿢ To FBM Industria Farmaceutica Ltda To Commercialize In Brazil

GREENWOOD VILLAGE, Colo. and GOIANIA, GOIAS, Brazil, March 22, 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"), and FBM Industria Farmaceutica Ltda ("FBMFarma"), a member of the HOSPFAR Group that manufactures, imports and distributes pharmaceuticals in Brazil, today announced a license and distribution agreement providing FMBFarma exclusive rights to market Zertane™ in Brazil for the treatment of premature ejaculation (PE). Financial terms were not disclosed at the request of FBMFarma, who will be responsible for obtaining regulatory approval, marketing and distribution in Brazil

Michael Macaluso, Ampio's CEO, noted… "As regulatory pathways and cultural attitudes in regards to sexual dysfunction drugs vary from country to country, we believe that optimizing Zertane™ sales around the world would best be accomplished with country and region specific partners, each carefully chosen, and not with a single global partner.  Each partner would be required to have a strong presence and be committed to, and capable of, mounting a comprehensive campaign to launch and grow the sales of the product. This criteria led to our recent licensing of Daewong Pharmaceuticals to distribute Zertane ™ in Korea. Using the same analysis, in Brazil, it was clear that FBMFarma was the ideal partner for Ampio."

Alexandre Ferreira, FBM group's Director of Marketing said... "FBM group expanded into the pharmaceutical business in Brazil 21 years ago. It is a 100% privately owned company with a distribution arm, HOSPFAR, that is ranked among the top 5 distributors in Brazil. HOSPFAR actively sells into both the private and public markets in this country, responding to almost all Brazilian Government tenders.
 FBM, the manufacturing branch of the group, is focused on the demand generation, through medical detailing, primarily focused on therapeutic products in the fields of: Urology, Male and Female Hormone Replacement Therapy, Fertility treatment, chemical addiction management and orphan diseases.
 FBM group executives are very pleased to establish this partnership with Ampio, since they are extremely confident and enthusiastic about the success that Zertane ™ will have in the Brazilian market."


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 and formulation 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.

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