Breckenridge has entered into another separate agreement with Helm AG to develop and manufacture an ANDA for an asthma drug product. Under terms of this new agreement, Breckenridge will submit an ANDA to the US Food and Drug Administration (FDA) in 2009 for the product which is in development by Helm AG. The product currently shows US sales of approximately $4 Billion Dollars, and is patent protected until 2012.
The two companies previously announced plans to develop and manufacture two other separate ANDA products. The first product was filed with the US Food and Drug Administration (FDA) in early 2008, and the second will be filed in early 2009.
Breckenridge Pharma is a privately held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of ValuBrand and Generic prescription products in many therapeutic categories.
Helm AG is an international chemical and pharmaceutical organization and a multifunctional marketing group which operates as a link between producers and industrial end users.