HAYWARD, Calif.--(BUSINESS WIRE)--March 8, 2004--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug
Administration (FDA) has granted tentative approval to the Company's
Abbreviated New Drug Application (ANDA) for its generic version of
Tricor(R) (Fenofibrate) Tablets. Tricor Tablets are marketed by Abbott
Laboratories, Inc. (NYSE:ABT) to assist patients in managing their
cholesterol levels. The drug is indicated for use in reducing elevated
LDL cholesterol, total cholesterol, triglycerides and Apo B and
increasing HDL cholesterol in patients with primary
hypercholesterolemia or mixed lipidemia. The drug has also been
approved as adjunctive therapy for the treatment of
hypertriglyceridemia, a disorder characterized by elevated levels of
very low density lipoprotein (VLDL) in the plasma. According to
NDCHealth, U.S. sales of Tricor Tablets were approximately $590
million for the 12 months ended December 31, 2003.
Final FDA approval is contingent upon the earlier of the
resolution of pending patent-infringement litigation brought by Abbott
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.
"This is our fourth ANDA approval this year and reflects the
strength of both our R&D and Regulatory teams," said Larry Hsu, Ph.D.,
IMPAX's President. "We are pleased to see our new product pipeline
continue to progress through FDA."
The FDA accepted for review IMPAX's Fenofibrate Tablets
application in December 2002. IMPAX's submission included a Paragraph
IV certification stating that, to the Company's knowledge, the product
does not infringe upon Abbott's listed Tricor Tablet patents or that
they are invalid. Abbott Laboratories (NYSE:ABT) has filed lawsuits
against the Company in the federal district court in Delaware alleging
patent infringement related to IMPAX's filing of its ANDA for
Fenofibrate Tablets. These lawsuits are ongoing.
IMPAX currently has 19 applications pending at the FDA, including
six tentatively approved, which address approximately $6.8 billion in
U.S. branded product sales for the twelve months ended December 31,
2003. Fourteen 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: Company Contacts:
IMPAX Laboratories, Inc.
Barry R. Edwards, 215-289-2220, Ext. 1771
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, 212-838-3777
[email protected]
or
Bruce Voss, 310-691-7100
[email protected]
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.