HAYWARD, Calif.--(BUSINESS WIRE)--June 18, 2004--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug
Administration (FDA) has granted IMPAX a second tier 180-day
exclusivity related to its pending ANDA for a generic version of
Glucophage XR(R), Metformin HCl Extended Release Tablets, 500mg. Impax
has selectively waived its rights to this exclusivity to Teva
Pharmaceuticals USA Inc. and will be sharing in the profits of Teva's
Metformin HCl Extended Release Tablets as provided for in the
Strategic Alliance Agreement between IMPAX and Teva signed in June
2001. It is believed at least one other company may participate in
this second tier of exclusivity. According to IMS Health, U.S. market
sales of Glucophage XR 500mg and the other marketed generic and
authorized generic versions were approximately $430 million in the
twelve months ended March 31, 2004.
IMPAX currently has 14 applications pending at the FDA, including
five tentatively approved, which address approximately $5.2 billion in
U.S. product sales for the twelve months ended March 31, 2004, based
on NDCHealth data. Twelve 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, (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 (kgolodetz@lhai.com)
(212) 838-3777
Bruce Voss (bvoss@lhai.com)
(310) 691-7100
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.