HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 6, 2004--IMPAX
Laboratories, Inc. (Nasdaq: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
Wellbutrin SR(R) (Bupropion Hydrochloride) 200mg Tablets. 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's Global Pharmaceuticals
division will begin marketing this product in the near future.
"We are happy to have received this approval, our second with
first-to-file exclusivity," said Larry Hsu, Ph.D., IMPAX's President.
"This, our eleventh approval in 2004, continues to validate our
ability to develop products that have limited market competition."
IMPAX currently has 14 applications pending at the FDA, including
four tentatively approved, which address approximately $5 billion in
U.S. branded product sales for the 12 months ended October 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, 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
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.