Breckenridge Pharmaceutical Enters Agreement With Helm AG (Hamburg, Germany) to Develop Third ANDA Project

Wednesday, December 24, 2008 General News J E 4
BOCA RATON, Fla., Dec. 23 Breckenridge announced todaythat it has entered into another separate agreement with Helm AG to developand manufacture an ANDA for an asthma drug product. Under terms of this newagreement, Breckenridge will submit an ANDA to the U.S. Food and DrugAdministration (FDA) in 2009 for the product which is in development by HelmAG. The product currently shows U.S. sales of approximately $4 billion, and ispatent protected until 2012.

The two companies previously announced plans to develop and manufacturetwo other separate ANDA products. The first product was filed with the U.S.Food and Drug Administration (FDA) in early 2008, and the second will be filedin early 2009.

About Breckenridge:

Breckenridge Pharmaceutical is a privately held pharmaceutical marketing,research and development company founded in 1983 that markets a broad range ofValuBrand(TM) and Generic prescription products in many therapeuticcategories. The Breckenridge label is recognized by Wholesalers, Distributors,Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide.The company markets over 100 products, more than 150 sku's, in a variety ofdosage forms including: Tablets, Capsules, Soft Gel Capsules, Liquids,Suspensions and Topical preparations.

About Helm AG:

HELM AG is an international chemical and pharmaceutical organization and amultifunctional marketing group which operates as a link between producers andindustrial end users. With branch offices and participations in 32 countriesHELM provides a wide range of services including marketing, distribution,production, logistics, generic development and registration.

SOURCE Breckenridge Pharmaceutical


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