Agreement Covers Loratadine/Pseudoephedrine Sulfate Products for the OTC
Market
June 20, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced
the signing of a semi-exclusive Development, License and Supply Agreement with
Wyeth acting through its Wyeth Consumer Healthcare Division relating to IMPAX's
generic versions of Claritin-D® 12-Hour (Loratadine/Pseudoephedrine Sulfate,
5 mg/ 120 mg) and Claritin-D® 24-Hour (Loratadine/Pseudoephedrine Sulfate,
10 mg/ 240 mg) Extended Release Tablets for the over-the-counter (OTC) market.
Claritin-D® 12-Hour and 24-Hour are currently marketed by Schering-Plough
as prescription drugs for the relief of symptoms of seasonal allergic rhinitis
(hay fever). According to IMS Health, U.S. sales for both products were approximately
$925 million for the twelve months ended March 31, 2002.
Schering-Plough said in a March 8, 2002 announcement that it has filed with
the U.S. Food and Drug Administration (FDA) to switch all of Claritin's formulations
from prescription to OTC marketing status.
"We are very excited to be working with Wyeth on these products,"
said Barry R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories. "They
have built a solid reputation as a strong marketer and we are pleased to have
them as a partner for the OTC marketing of these products."
Both of the Company's Abbreviated New Drug Applications (ANDAs) for Loratadine/Pseudoephedrine
Sulfate Extended Release Tablets have previously been granted tentative approval
by the U.S. Food and Drug Administration (FDA).
IMPAX currently has 15 Abbreviated New Drug Application (ANDA) filings pending
at the FDA that address more than $8.7 billion in U.S. branded product sales
during 2001. Nine of these filings were made under Paragraph IV of the Hatch-Waxman
Amendments, three of which have received tentative approval from FDA.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company
applying its formulation expertise and drug delivery technology to the development
of controlled-release and niche generics in addition to the development of branded
products. IMPAX markets its generic products through its Global Pharmaceuticals
division and intends to market its branded products through the IMPAX Pharmaceuticals
division. IMPAX Laboratories is headquartered in Hayward, California, and has
a full range of capabilities in its Hayward and Philadelphia facilities. For
more information, please visit the Company's Web site at: www.impaxlabs.com.