HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 19, 2003--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) today announced that the United
States Food and Drug Administration (FDA) has accepted the Company'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.
Shire Pharmaceuticals Group plc (Nasdaq:SHPGY) (TSX:SHQ) (LSE:SHP)
markets the product for the treatment of Attention Deficit and
Hyperactivity Disorder (ADHD). According to NDCHealth, U.S. sales of
Adderall XR Capsules were approximately $540 million in the twelve
months ended September 30, 2003. Shire received initial FDA approval
of this product in October of 2001.
IMPAX's application includes a certification under Paragraph IV of
the Hatch-Waxman Amendments stating the Company's belief that its
generic version of Adderall XR Capsules does not infringe certain
Shire listed patents on Adderall XR Capsules. FDA's acceptance of the
IMPAX ANDA for filing means that the Agency has made a threshold
determination that the application is sufficiently complete to permit
a substantive review.
IMPAX has 18 applications pending at the FDA, including three
tentatively approved that address approximately $7 billion in U.S.
branded product sales for the 12 months ended September 30, 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: 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
Lippert/Heilshorn & Associates, Inc.
(Investor Relations)
Kim Sutton Golodetz (kgolodetz@lhai.com)
212-838-3777
Bruce Voss (bvoss@lhai.com)
310-691-7100
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.