HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 14, 2005--IMPAX
Laboratories, Inc. (OTC:IPXL) announced that the U.S. Food and Drug
Administration (FDA) has granted final approval to the Company's
Abbreviated New Drug Application (ANDA) for a generic version of
Glucophage(R) XR 750 mg (Metformin HCI extended-release tablets).
Bristol Meyers Squibb Company (NYSE:BMY) markets Glucophage XR as an
antidiabetic drug for the treatment of Type 2 (non-insulin dependent)
diabetes. According to NDCHealth, U.S. sales of Glucophage XR 750 mg
were approximately $23 million in the 12 months ended June 2005.
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. In particular, the forward-looking statements include
statements about IMPAX's common stock trading through the "pink
sheets" and making required filings with the Securities and Exchange
Commission and otherwise satisfying Nasdaq listing standards in order
to regain the listing of its common stock. 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, 215-933-0323 Ext. 4360
Arthur A. Koch, Jr., 215-933-0351
Larry Hsu, Ph.D., 510-476-2000 Ext. 1111
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.