HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 24, 2003--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug
Administration (FDA) has granted tentative approval to the Company's
Abbreviated New Drug Application (ANDA) for generic versions of
OxyContin(R) (Oxycodone Hydrochloride) Controlled Release Tablets, 10,
20 and 40 mg. Purdue Pharma markets OxyContin for the management of
moderate to severe pain. According to NDCHealth, U.S. sales of
OxyContin Controlled Release Tablets, 10, 20 and 40 mg, were $1,182
million for the 12 months ended October 31, 2003.
Final approval is contingent upon the earlier of the resolution of
pending patent-infringement litigation brought by Purdue Pharma
against IMPAX, or the expiration of the 30-month stay process under
the Hatch-Waxman Amendments; and the expiration of any generic
marketing exclusivity. Final approval is also dependent upon FDA's
evaluation of any new information subsequent to this tentative
approval.
IMPAX Laboratories previously announced FDA acceptance of the
Company's ANDA filing for Oxycodone Hydrochloride Extended Release
Tablets, 10, 20 and 40 mg, and commented on the filing of a lawsuit by
Purdue Pharma alleging patent infringement relating to the ANDA in
September 2002. The litigation with Purdue Pharma is still ongoing.
"This tentative approval is our ninth ANDA approval this year,"
said Larry Hsu, Ph.D., president of IMPAX Laboratories. "We are
pleased to see our new product pipeline continue to progress through
FDA and add to our growing portfolio of products."
IMPAX currently has 20 applications pending at the FDA, including
four tentatively approved, which address approximately $7.1 billion in
U.S. branded product sales for the 12 months ended October 31, 2003.
Fifteen 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, 215-289-2220, Ext. 1771
Larry Hsu, 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, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.