HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 19, 2006--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that it has reached a
settlement with an affiliate of Britain's Shire Pharmaceuticals Group
Plc ("Shire") covering all patent litigation between the parties
related to Adderall XR(R) (mixed amphetamine salts). Under the
settlement, IMPAX will be permitted to market generic versions of
Adderall XR in the United States no later than January 1, 2010. In
certain situations, such as the launch of another generic version of
Adderall XR, IMPAX may be permitted to enter the market as Shire's
authorized generic. IMPAX will pay Shire a royalty from its generic
sales of Adderall XR.
Adderall XR is marketed by Shire for attention deficit
hyperactivity disorder (ADHD). According to NDCHealth, U.S. gross
sales of Adderall XR tablets were approximately $912 million in the 12
months ended November 30, 2005.
Larry Hsu, Ph.D., IMPAX's President, commented, "This agreement is
a win-win for both companies as we are now able to resolve the
uncertainty of the outcome of litigation and prevent the suit from
becoming an even more costly and time consuming dispute."
In a separate agreement, IMPAX will promote Carbatrol(R)
(carbamazepine extended release capsules), Shire's product for the
treatment of epilepsy beginning around July 2006. The general
framework of the agreement calls for IMPAX to receive approximately
$40 million over three years to detail physicians with the product and
related information. IMPAX has agreed to perform a minimum number of
such activities over the three year period. Also under the agreement,
IMPAX is entitled to certain incentive payments based on prescription
growth. Other terms of the agreement are confidential and were not
disclosed.
Carbatrol had U.S. gross sales of $78 million for the twelve
months ended November 30, 2005, according to NDCHealth.
IMPAX initially plans to recruit and deploy approximately 66 to 70
specialty sales representatives, either directly or through a contract
sales arrangement with a third party, or a combination of both. The
primary target market for Carbatrol of approximately 8,300
neurologists in the U.S. overlaps with the Company's target market for
Vadova(TM) (carbidopa and levodopa). IMPAX's branded product Vadova is
actively under review by the U.S. Food and Drug Administration and is
expected to be approved this year, thus IMPAX intends to achieve
synergies in its overall sales and marketing costs.
Commenting on the agreement, Mr. Barry R. Edwards, IMPAX's CEO,
said, "With two important CNS products to market to physicians
available at approximately the same time, IMPAX plans to establish a
position in the branded products market category from the day we enter
the market. We believe this will enhance our reputation in the
marketplace, as well as lower our overall sales and marketing costs on
a per-product basis. We are very pleased to have earned Shire's
confidence and we are looking forward to a mutually rewarding,
long-term relationship."
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 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 the delisting of IMPAX's stock, IMPAX's delay
in filing its 2004 Form 10-K and its Form 10-Q's for the first three
quarters of 2005, 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, 215-933-0360
Larry Hsu, Ph.D., 510-476-2000, Ext. 1111
Arthur Koch, 215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz ([email protected])
212-838-3777
Bruce Voss ([email protected])
310-691-7100
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.