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 www.impaxlabs.com.