HAYWARD, Calif.--(BUSINESS WIRE)--April 18, 2005--IMPAX
Laboratories, Inc. (NASDAQ:IPXLE) 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
Agrylin(R) (Anagrelide Hydrocloride) HCI 0.5 and 1.0 mg capsules.
Shire Pharmaceuticals markets Agrylin for the treatment of
thrombocytosis and essential thrombocythaemia. U.S. sales of Agrylin
HCI 0.5 and 1.0 mg capsules were approximately $109 million in the 12
months ended December 31, 2004, according to NDCHealth. IMPAX's Global
Pharmaceuticals division intends to begin marketing this product
immediately.
"We are pleased to have received this approval, our third of
2005," said Larry Hsu, Ph.D. Impax's President. "This is a further
step in our strategy to commercialize niche pharmaceuticals."
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 Impax's delay in filing its 2004 Form 10-K
including possible delisting from the NASDAQ National Market, 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: Company Contacts:
IMPAX Laboratories, Inc.
Barry R. Edwards, CEO, (215) 933-0323 Ext. 4360
Larry Hsu, Ph.D., President, (510) 476-2000 Ext. 1111
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, (212) 838-3777
Bruce Voss, (310) 691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.