June 24, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced
the signing of a Licensing, Contract Manufacturing and Supply Agreement with
Schering-Plough Corporation relating to CLARITIN-D® 12 Hour (loratadine/pseudoephedrine
sulfate, 5 mg/ 120 mg) Extended Release Tablets for the over-the-counter (OTC)
market. CLARITIN-D 12 Hour is currently manufactured and marketed in the United
States by Schering-Plough as a prescription drug for the relief of symptoms
of seasonal allergic rhinitis (hay fever).
Schering-Plough said in a March 8, 2002 press release that it has filed with
the U.S. Food and Drug Administration (FDA) to switch all CLARITIN formulations
from prescription to OTC marketing status.
"We are pleased to be working with Schering-Plough on this important product,"
said Barry R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories. "They
have built a strong franchise in CLARITIN and we are excited they chose us to
assist as a manufacturing source to meet the demands for CLARITIN-D 12 Hour
for the OTC market." Edwards continued, "We believe this agreement
complements our two previously announced OTC marketing alliances for loratadine
products and adds a whole new dimension to our OTC strategy."
This agreement does not resolve the ongoing patent litigation between Schering-Plough
and IMPAX to decide whether the Company may market its generic CLARITIN-D 12
Hour product or manufacture such a product for companies other than Schering-Plough
prior to the expiration of a Schering-Plough patent in 2004.
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.