IMPAX Comments on Claritin Announcement by Schering-Plough

March 13, 2002
Also Announces Alliance With Novartis Consumer Health, Inc. for an OTC Loratadine Product

March 13, 2002 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) comments on Schering-Plough Corporation's announcement that it will seek approval to market Claritin® as an over-the-counter (OTC) product.

Schering-Plough markets Claritin® products for the relief of symptoms of seasonal allergic rhinitis. In addition, IMPAX today announces an agreement with Novartis Consumer Health, Inc. for the marketing of an OTC Loratadine product. Loratadine is the generic name of the active ingredient in Claritin®.

``Schering-Plough's 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 is somewhat expected as this has been the topic of much press over the past few years. However, the timing of the switch to OTC has always been uncertain,'' said Barry R. Edwards, Co-Chief Executive Officer of Impax Laboratories. ``In anticipation of such a potential event, we have previously struck an alliance with Novartis Consumer Health for OTC marketing rights and supply of a Loratadine product as part of our overall OTC strategy. We are also continuing our discussions with potential OTC partners for two additional generic formulations of Claritin.''

Impax currently has 15 Abbreviated New Drug Application (ANDA) filings pending at the FDA that address more than $8 billion in U.S. branded product sales during 2001. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments, one of which has received tentative approval from FDA. The announcement by Schering-Plough may impact up to three of the Company's fifteen pending ANDA filings representing $1.25 billion in U.S. branded product sales during 2001.

``The Company's strategy is to have a broad product portfolio so that we are not overly dependent on the outcome of any one product or filing at the FDA,'' said Larry Hsu, Ph.D., President and Chief Operating Officer of Impax Laboratories. ``Over the past two years we have filed sixteen ANDAs with the FDA and we expect to file an additional six to eight ANDAs this year which will broaden our product portfolio further. In addition, we continue to expect our first branded product filing in the near future as we build a brand business to complement our existing generic business.''

``We are constantly looking at business opportunities and we will evaluate our OTC strategy in response to this announcement by Schering-Plough,'' says Charlie Hsiao, Ph.D., Chairman and Co-Chief Executive Officer of Impax Laboratories. ``This is a very complex situation and it is too early to tell what the overall impact will be on our generic Claritin® filings.''

As a key part of its generic marketing strategy the Company has an alliance with Teva Pharmaceutical (NASDAQ NM:TEVA) covering eleven products (seven of which are currently filed with the FDA) and an option on one further product currently filed with the FDA.

``Our strategic alliance with Teva covers a wide range of products and we do not expect that the substance of our agreement will be substantially affected by the Schering-Plough announcement,'' commented Barry R. Edwards. ``There are provisions within the agreement that deal with possible OTC competition. This is a comprehensive alliance covering the marketing rights to many products both in the U.S. as well as overseas.''

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