HAYWARD, Calif.--(BUSINESS WIRE)--March 3, 2005--IMPAX
Laboratories, Inc. (NASDAQ:IPXL) has begun commercial distribution of
its generic version of OxyContin(R) (Oxycodone Hydrochloride)
Controlled Release 80 mg Tablets. The product is being sold under the
Global label and marketed by IMPAX's Global Pharmaceuticals division.
The U.S. Food and Drug Administration (FDA) granted final approval
to the company's Abbreviated New Drug Application in late September
2004. IMPAX agreed not to market the product until FDA deemed the
Company's Risk Management Program (RMP) acceptable. The Company's
revised RMP now is acceptable to the regulatory agency.
Purdue Pharma markets OxyContin for the management of moderate to
severe pain. According to NDCHealth, U.S. sales of OxyContin
Controlled Release 80 mg Tablets and its generic equivalent were $677
million for the 12 months ended December 31, 2004.
Commenting on the product launch, Barry R. Edwards, chief
executive officer, said, "Last January 2004 the U.S. District Court
for the Southern District of New York issued an Opinion and Order in
Purdue v. Endo declaring Purdue Frederick's patents on its OxyContin
invalid. Purdue has appealed this decision and those arguments were
heard in November 2004. A decision has not yet been rendered and if
the court finds in favor of Purdue, IMPAX could, at some point, be
liable for damages as a result of the product launch. If the Endo
decision on unenforceability is reversed, Endo raised additional
defenses at trial, which have yet to be decided by the district court,
and IMPAX will have the opportunity to present additional defenses as
well. The decision to launch was made after a great deal of
deliberation and thought by our Board of Directors. The pace of our
initial product rollout is expected to be slow and grow over time."
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, 215-933-0323 Ext. 4360
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.