HAYWARD, Calif., Dec 30, 2003 (BUSINESS WIRE) -- IMPAX
Laboratories, Inc. (Nasdaq:IPXL) today announced that Shire
Laboratories Inc., a subsidiary of Shire Pharmaceuticals Group plc
(Nasdaq:SHPGY; TSX:SHQ; LSE:SHP), has filed a lawsuit against the
Company in the United States District Court for the district of
Delaware alleging patent infringement related to IMPAX's filing of an
Abbreviated New Drug Application (ANDA) for a generic version of
Adderall XR(R) 30mg Capsules.
Adderall XR is a once daily, extended-release, mixed salts of a
single-entity amphetamine product used for the treatment of Attention
Deficit and Hyperactivity Disorder (ADHD). According to NDCHealth,
U.S. sales of Adderall XR Capsules were approximately $550 million in
the twelve months ended October 31, 2003.
The U.S. Food and Drug Administration (FDA) accepted for review
IMPAX's application to market a generic version of Shire's Adderall XR
30 mg capsules in September 2003. IMPAX's submission included a
Paragraph IV certification stating the Company believes its product
does not infringe upon Shire's listed patents.
Barry R. Edwards, Co-Chief Executive Officer of IMPAX
Laboratories, commented, "This type of lawsuit has become standard
practice in the industry and we are not surprised that Shire filed
this action. It is a routine part of the process we need to go through
in getting these complex generic products to market. We believe our
product as formulated does not infringe upon Shire's patents and will
provide a safe, effective and affordable alternative in the
marketplace. We will proceed accordingly to defend our application."
IMPAX currently has 20 applications pending at the FDA, including
four tentatively approved, which address approximately $7.1 billion in
U.S. branded product sales for the 12 months ended October 31, 2003.
Fifteen 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.
SOURCE: IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Barry R. Edwards, 215-289-2220, ext. 1771
Larry Hsu, Ph.D., 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
or
Bruce Voss (bvoss@lhai.com)
310-691-7100
www.lhai.com
Customize your Business Wire news & multimedia to match your needs.
Get breaking news from companies and organizations worldwide.
Logon for FREE today at www.BusinessWire.com.