HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 28, 2004--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug
Administration (FDA) has granted final approval to the Company's
Abbreviated New Drug Application (ANDA) for a generic version of
OxyContin(R) (Oxycodone Hydrochloride) Controlled Release 80mg
Tablets. Purdue Pharma markets OxyContin for the management of
moderate to severe pain. According to NDCHealth, U.S. sales of
OxyContin Controlled Release 80mg Tablets and its generic equivalent
were $688 million for the 12 months ended July 31, 2004.
Included in communications with the FDA related to the final
approval is a commitment by the Company not to launch the product
until a revised Risk Management Program (RMP) has been submitted to,
and is found acceptable by, the FDA. A revised RMP has recently been
submitted to the FDA by the Company.
"This is our tenth ANDA approval this year, which exceeds our full
year total of nine in 2003," commented Barry R. Edwards, Chief
Executive Officer of IMPAX. "We received tentative approval for the
product late in 2003 and had anticipated final approval following the
expiration of marketing exclusivity for the first ANDA filer.
Operationally, we have been making preparations for a market launch,
but because of outstanding issues, including pending patent
infringement litigation by Purdue, a final decision on timing has not
yet been made," Mr. Edwards continued.
IMPAX currently has 14 applications pending at the FDA, including
four tentatively approved, which address approximately $4.3 billion in
U.S. branded product sales for the 12 months ended July 31, 2004. Nine
of these filings were made under Paragraph IV of the Hatch-Waxman
Amendments.
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, CFO, 215-289-2220 ext. 1706
www.impaxlabs.com
or
Lippert/Heilshorn & Associates, Inc. (Investor Relations)
Kim Sutton Golodetz, 212-838-3777
[email protected]
Bruce Voss, 310-691-7100
[email protected]
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.