HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 15, 2008--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that it has filed a
lawsuit against Medicis Pharmaceutical Corporation in the United
States District Court for the Northern District of California
requesting a declaration that IMPAX does not infringe any valid claims
of U.S. Patent No. 5,908,838 related to IMPAX's filing in October 2007
of an Abbreviated New Drug Application (ANDA) for minocycline
hydrochloride extended-release tablets, a generic version of
SOLODYN(R).
IMPAX's ANDA does not contain any patent certification under
Paragraph IV of the Hatch-Waxman amendments because no patents for the
SOLODYN(R) product are listed in Approved Drug Products with
Therapeutic Equivalence Evaluations (commonly known as the Orange
Book), published by the U. S. Food and Drug Administration. Certain
antibiotic products are not subject to these Hatch-Waxman procedures
and, therefore, do not have patents listed in the Orange Book and are
not subject to the patent certification requirements.
Medicis Pharmaceutical Corporation markets SOLODYN(R) tablets for
the treatment of inflammatory lesions of non-nodular moderate to
severe acne vulgaris in patients 12 years of age and older. U.S. sales
of SOLODYN(R) tablets were approximately $216.7 million in the 12
months ended November 30, 2007.
About IMPAX Laboratories, Inc.
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 markets 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, possible adverse
effects resulting from the delisting of and suspension of trading in
IMPAX's stock, the SEC proceeding to determine whether to suspend or
revoke the registration of IMPAX's securities under section 12 of the
Securities Exchange Act, IMPAX's delay in filing its 2004 Form 10-K,
its Form 10-Q for each of the first three quarters of 2005, 2006, and
2007, its Form 10-K for 2005 and 2006, the actual time that will be
required to complete the filing of IMPAX's delinquent periodic
reports, 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: Company Contacts:
IMPAX Laboratories, Inc.
Larry Hsu, Ph.D. President & CEO
510-476-2000, Ext. 1111
Arthur Koch, CFO
215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.