Impax Confirms Patent Challenge Relating to WELCHOL® for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet
November 22 2010 - 9:15AM
Business Wire
Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms
that it has initiated a challenge of patents listed by Daiichi
Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) for
Oral Suspension, 3.75 gm/packet and 1.875 gm/packet.
Impax filed its Abbreviated New Drug Application (ANDA)
containing a paragraph IV certification for a generic version of
WELCHOL® with the U.S. Food & Drug Administration (FDA).
Following receipt of the notice from the FDA that Impax’s ANDA had
been accepted for filing, Impax notified the New Drug Application
holder and patent owners of its paragraph IV certification.
On November 19, 2010, Daiichi Sankyo, Inc. and Genzyme
Corporation filed suit for patent infringement against Impax in the
United States District Court for the District of Delaware. This
action formally initiates the patent challenge process under the
Hatch-Waxman Act.
Once the ANDA is approved by FDA, 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,
reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years
of age, with heterozygous familial hypercholesterolemia as
monotherapy or in combination with a statin after failing an
adequate trial of diet therapy, and improve glycemic control in
adults with type 2 diabetes mellitus. According to Wolters
Kluwer Health, U.S. sales of WELCHOL® for Oral Suspension were
approximately $39 million for the twelve-month period ending
September 2010.
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 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 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, 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 FDA 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 SEC. 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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