Impax Laboratories Announces Settlement of Litigation Relating to WELCHOL® Tablets and WELCHOL® Oral Suspension Products
June 30 2011 - 8:00AM
Business Wire
Impax Laboratories, Inc. (NASDAQ: IPXL) today
announced that it has reached agreement with Daiichi Sankyo, Inc.
and Genzyme Corporation to settle pending patent litigation
relating to its generic versions of WELCHOL® (colesevelam HCl)
tablets, 625 mg and oral suspensions, 1.875 gm/packet and 3.75
gm/packet products. Under the terms of the settlement, Impax will
be permitted to launch its tablet product on March 2, 2015 or
earlier under certain circumstances. The settlement further
provides for the launch of the oral suspension products, under
terms that were not disclosed. As a result of this settlement, the
litigation will be dismissed.
The Company believes that it is the first to file an ANDA with a
paragraph IV certification with respect to the colesevelam HCl
625mg tablet product, and expects to be entitled to at least three
months of market exclusivity prior to the launch of additional ANDA
products. Upon the agreed-upon launch dates, Global
Pharmaceuticals, Impax’s generic division, will commercialize the
products.
WELCHOL® is indicated as an adjunct to diet and exercise to
reduce elevated low-density lipoprotein cholesterol (LDL-C) in
patients with primary hyperlipidemia (Fredrickson Type IIa) as
monotherapy or in combination with an
hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor and
for the treatment of type 2 diabetes mellitus. According to Wolters
Kluwer Health, U.S. sales of WELCHOL® Tablets and WELCHOL Oral
Suspension were approximately $325 million and $65 million,
respectively, for the twelve-month period ending May 2011.
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 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 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; ability to timely file periodic reports required by the
Exchange Act; ability to maintain an effective system of internal
control over financial reporting; ability to sustain profitability
and positive cash flows; ability to maintain sufficient capital to
fund operations; any delays or unanticipated expenses in connection
with the construction of our Taiwan facility; ability to
successfully develop and commercialize pharmaceutical products; the
uncertainty of patent litigation; consumer acceptance and demand
for new pharmaceutical products; the impact of competitive products
and pricing; the difficulty of predicting Food and Drug
Administration filings and approvals; inexperience in conducting
clinical trials and submitting new drug applications; reliance on
key alliance agreements; the availability of raw materials; the
regulatory environment; exposure to product liability claims;
fluctuations in operating results and other risks described in our
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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