HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 6, 2005--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and
Drug Administration (FDA) has granted final approval to the Company's
Abbreviated New Drug Application for a generic version of OxyContin(R)
(Oxycodone Hydrochloride) Controlled Release 10mg, 20mg, and 40mg
Tablets. Purdue Pharma markets OxyContin for the management of
moderate to severe pain. According to NDCHealth, U.S. sales of
OxyContin Controlled Release 10mg, 20mg, and 40mg Tablets and its
generic equivalent were $1.2 billion for the 12 months ended September
2005. IMPAX intends to begin marketing this product immediately
through its previously announced exclusive supply and distribution
agreement with DAVA Pharmaceuticals, Inc. DAVA will have exclusive
sales and distribution rights in the United States and Puerto Rico and
IMPAX will be responsible for all manufacturing and regulatory
aspects.
"We are pleased to have received this approval, our sixth of
2005," said Larry Hsu, Ph.D., IMPAX's president. "This is a
significant complement to our existing 80mg business and with it, we
and our marketing partner will be able to provide a more comprehensive
offering for patients suffering from moderate to severe pain."
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, possible adverse
effects resulting from the delisting of IMPAX's stock, IMPAX's delay
in filing its 2004 Form 10-K and its Form 10-Q's for the first two
quarters of 2005, 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, 215-933-0360
Larry Hsu, Ph.D., 510-476-2000, Ext. 1111
Arthur Koch, 215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.