Ampio Pharmaceuticals Announces the Licensing of Zertane™ to FBM Industria Farmaceutica Ltda to Commercialize in Brazil
Mar 22, 2012, 07:00 ET
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."
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.
FBMPharma, founded in 2000, has become a leading pharmaceutical manufacturer and distributor in Brazil, the seventh largest and second fastest growing economy in the world. Employing over 1,000 people FBMFarma distributes a wide range of medical products, including pharmaceuticals, blood derivatives, medical devices and intraocular lens. FBMFarma's six state-of-the-art manufacturing facilities produce an array of medicines, cosmetics, medical devices and nutritional products. FBMFarma has eight regional sales and distribution facilities strategically deployed to serve all parts of Brazil with the goal of providing same day delivery of its products. Its success is the result of a constant concern for excellence in service with quality, responsibility and ethics.
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.
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: Investor Relations Ampio Pharmaceuticals, Inc. 720-437-6500
SOURCE Ampio Pharmaceuticals, Inc.
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