Impax Laboratories Announces Litigation Against Shire Relating to Supply of Generic Adderall XR®
November 01 2010 - 10:32AM
Business Wire
Impax Laboratories, Inc. (NASDAQ: IPXL) today
announced that it has initiated litigation against Shire LLC and
Shire Laboratories, Inc. (“Shire”) in order to resolve recent and
recurring supply issues of its authorized generic version of
Adderall XR®. The Company is seeking to compel Shire to deliver
duly ordered amounts of product under the parties’ Settlement
Agreement and License and Distribution Agreements.
Larry Hsu, Ph.D., president and chief executive officer of Impax
Laboratories, said: “Since launching our generic product in October
of 2009, we have experienced very strong customer demand, as
reflected in our strong sales of the product earlier in the year.
Because of Shire’s failure to continue to supply us with product in
accordance with our agreement, we have been unable to continue to
satisfy our customers’ demands, resulting in declining sales and
market share for this product. Throughout the year we have made
numerous attempts to resolve the ongoing supply issues, and based
on representations by Shire, we anticipated a significant increase
in our fourth quarter sales over third quarter levels. According to
very recent statements by Shire, however, it appears that Shire has
no intention of filling our open orders, and we therefore believe
we had no alternative but to bring this lawsuit in order to protect
the interests of our customers and shareholders.”
In January 2006, Impax Laboratories entered into a Settlement
Agreement and a License and Distribution Agreement with Shire as
part of a settlement of patent litigation between the parties.
Under the settlement, Shire permitted the Company to enter the
market as Shire’s authorized generic and market generic versions of
Adderall XR® Capsules in the United States. On or about October 1,
2009, Global Pharmaceuticals, Impax’s generic division, commenced
sales of its authorized generic version of Adderall XR® Capsules,
5mg, 10mg, 15mg, 20mg, 25mg and 30mg.
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, Philadelphia and Taiwan
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 the Company’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, the effect of current economic conditions on the
Company’s industry, business, financial position, results of
operations and market value of its common stock, the ability to
maintain an effective system of internal control over financial
reporting, fluctuations in revenues and operating income,
reductions or loss of business with any significant customer, the
impact of competitive pricing and products and regulatory actions
on the Company’s products, the ability to sustain profitability and
positive cash flows, the ability to maintain sufficient capital to
fund operations, any delays or unanticipated expenses in connection
with the operation of the Taiwan facility, the ability to
successfully develop and commercialize pharmaceutical products, the
uncertainty of patent litigation, consumer acceptance and demand
for new pharmaceutical products, the difficulty of predicting Food
and Drug Administration filings and approvals, the inexperience of
the Company in conducting clinical trials and submitting new drug
applications, reliance on key alliance and collaboration
agreements, the availability of raw materials, the ability to
comply with legal and regulatory requirements governing the
healthcare industry, the regulatory environment, exposure to
product liability claims and other risks described in the Company’s
periodic reports filed 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.
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