HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 18, 2007--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and
Drug Administration (FDA) has granted tentative approval to the
Company's Abbreviated New Drug Application (ANDA) for a generic
version of Effexor XR(R) (venlafaxine HCl) 37.5mg, 75mg and 150mg
extended release capsules.
Wyeth markets Effexor XR for the treatment of depression, panic
disorder and generalized and social anxiety disorder. U.S. sales of
Effexor XR were approximately $2.7 billion for the 12 months ended
August 31, 2007, according to Wolters-Kluwer Health.
Final approval is contingent upon the earlier of the resolution of
pending patent infringement litigation brought by Wyeth against IMPAX,
or the expiration of the 30-month stay process under the Hatch-Waxman
Amendments; and the expiration of any generic marketing exclusivity.
Final approval is also dependent upon FDA's evaluation of any new
information subsequent to this tentative approval.
"We are please to announce our fifth FDA approval this year. We
intend to continue to vigorously defend the ongoing patent litigation
with Wyeth and look forward to prevailing and bringing this important
generic product to market," said Larry Hsu, Ph.D., IMPAX's president
and chief executive officer.
About IMPAX Laboratories, Inc.
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 markets 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 the delisting of and suspension of trading in
IMPAX's stock, the SEC proceeding to determine whether to suspend or
revoke the registration of IMPAX's securities under section 12 of the
Securities Exchange Act, IMPAX's delay in filing its 2004 Form 10-K,
its Form 10-Q for each of the first three quarters of 2005 and 2006,
its Form 10-K for 2005 and 2006, and its Form 10-Q for the first and
second quarters of 2007, the actual time that will be required to
complete the filing of IMPAX's delinquent periodic reports, 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.
Larry Hsu, Ph.D. President & CEO
510-476-2000, x1111
or
Arthur Koch, CFO
215-933-0351
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.