HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 27, 2003--IMPAX
Laboratories, Inc. (NASDAQ:IPXL) today announced that it has entered
into a settlement and license agreement with Schering-Plough
Corporation (NYSE:SGP) related to IMPAX's generic version of
Claritin-D(R) 24-Hour (Loratadine and Pseudoephedrine Sulfate,
10mg/240mg) Extended Release Tablets. This agreement resolves all of
the outstanding patent litigation between the parties on this product.
The financial terms of the settlement and license, which remain
undisclosed, are not material to IMPAX's financial position or results
of operations.
"While we remain confident we would prevail in this
patent-infringement litigation, we believe this agreement with
Schering is in the best interest of both parties," commented Barry R.
Edwards, Co-Chief Executive Officer of IMPAX Laboratories. "This case
is currently at the summary motion phase and now, with this
settlement, we can eliminate any additional expense or delays due to
this lawsuit."
On May 29, 2002 IMPAX announced that it had received tentative
approval from the U.S. Food and Drug Administration (FDA) for the
Company's Abbreviated New Drug Application (ANDA) for this product.
The FDA's final approval is contingent upon the expiration of any
generic marketing exclusivity. Final approval is also dependent upon
FDA's evaluation of any new information subsequent to the tentative
approval.
According to NDCHealth, U.S. sales of Claritin-D 24-hour were
approximately $200 million for the 12 months ended August 31, 2003.
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
specialty 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. Additionally, where strategically
appropriate, IMPAX has developed marketing partnerships to fully
leverage its technology platform. 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.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations of
management. Such statements are based on current expectations and
involve a number of known and unknown risks and uncertainties that
could cause Impax's future results, performance or achievements to
differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Such risks
and uncertainties include, but are not limited to, Impax's ability to
obtain sufficient capital to fund its operations, the difficulty of
predicting FDA filings and approvals, consumer acceptance and demand
for new pharmaceutical products, the impact of competitive products
and pricing, Impax's ability to successfully develop and commercialize
pharmaceutical products, Impax's reliance on key strategic alliances,
the uncertainty of patent litigation, the availability of raw
materials, the regulatory environment, dependence on patent and other
protection for innovative products, exposure to product liability
claims, fluctuations in operating results and other risks detailed
from time to time in Impax's filings with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and Impax undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of
whether new information becomes available, future developments occur
or otherwise.
CONTACT: IMPAX Laboratories, Inc.
Barry R. Edwards, 215-289-2220, ext. 1771
Larry Hsu, Ph.D., 510-476-2000, ext. 1111
Cornel C. Spiegler, 215-289-2220, ext. 1706
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz (kgolodetz@lhai.com)
212-838-3777
Bruce Voss (bvoss@lhai.com)
310-691-7100
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.