HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 22, 2004--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) today announced that the Company has
begun commercial distribution of its Bupropion Hydrochloride 200mg
Extended Release Tablets. The product is being sold under the Global
label and marketed by IMPAX's Global Pharmaceuticals division.
As previously announced, the U.S. Food and Drug Administration
(FDA) granted final approval to the Company's Abbreviated New Drug
Application for a generic version of Wellbutrin SR(R) (Bupropion
Hydrochloride) 200mg Tablets on December 3, 2004. The FDA also awarded
the Company first-to-file status and 180-day market exclusivity for
this product. GlaxoSmithKline markets Wellbutrin SR for the treatment
of depression. U.S. sales of Wellbutrin SR 200mg Tablets were
approximately $212 million in the 12 months ended October 31, 2004,
according to NDCHealth.
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, Calif., 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, x4360
Larry Hsu, Ph.D., 510-476-2000, x1111
Cornel C. Spiegler, 215-289-2220, x1706
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.