BOCA RATON, Fla., Dec. 23 /PRNewswire/ -- Breckenridge announced today that it 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 U.S. Food and Drug Administration (FDA) in 2009 for the product which is in development by Helm AG. The product currently shows U.S. sales of approximately $4 billion, 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 U.S. Food and Drug Administration (FDA) in early 2008, and the second will be filed in early 2009.
About Breckenridge:
Breckenridge Pharmaceutical is a privately held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of ValuBrand(TM) and Generic prescription products in many therapeutic categories. 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 of dosage forms including: Tablets, Capsules, Soft Gel Capsules, Liquids, Suspensions and Topical preparations. www.bpirx.com
About Helm AG:
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. With branch offices and participations in 32 countries HELM provides a wide range of services including marketing, distribution, production, logistics, generic development and registration. www.helmag.com
CONTACT: Larry Lapila, Vice President Business Development, Breckenridge
Pharmaceutical, +1-860-828-8140, fax: +1-860-828-8142, llapila@bpirx.com;
Boy Ehlers, Vice President Pharmaceutical Division, Helm New York, Inc.,
+1-732-981-1160, fax: +1-732-981-0965, behlers@helmnewyork.com
Web site: http://www.bpirx.com/
http://www.helmag.com/
