Horizon Pharma Files Patent Infringement Lawsuit Against Watson Laboratories,
Inc. - Florida for Filing an ANDA Against RAYOS(R)
DEERFIELD, IL -- (Marketwired) -- 08/27/13 -- Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced it, along with SkyePharma from whom it
has licensed certain RAYOS(R) intellectual property, has filed a
patent infringement lawsuit in the United States District Court for
the District of New Jersey against Watson Laboratories, Inc. -
Florida and certain related companies ("WLF") and related to an
Abbreviated New Drug Application ("ANDA") that WLF filed with the
U.S. Food and Drug Administration ("FDA") to market generic versions
of RAYOS(R) containing 1 mg, 2 mg and 5 mg of prednisone.
The lawsuit claims infringement of U.S. Patent Nos. 6,488,960,
6,677,326, 8,168,218, 8,309,124 and 8,394,407 that are listed in the
FDA's Orange Book with the latest expiration January 7, 2028. Horizon
received a Paragraph IV Patent Certification from WLF on July 15,
2013, advising that WLF had filed an ANDA with the FDA for a generic
version of RAYOS(R). WLF alleged that its generic versions of
RAYOS(R) would not infringe the subject U.S. patents or the patents
are invalid or unenforceable. WLF has not advised Horizon as to the
timing or status of the FDA's review of its filing, or whether it has
complied with FDA requirements for proving bioequivalence. The
defendants in the lawsuit are Watson Laboratories, Inc. - Florida,
Actavis Pharma, Inc., Andrx Corp., and Actavis, Inc.
Horizon commenced the lawsuit within the 45 days required to
automatically stay, or bar, the FDA from approving WLF's ANDA for 30
months or until a district court decision that is adverse to the
subject patents, whichever may occur earlier.
About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical
company that is developing and commercializing innovative medicines
to target unmet therapeutic needs in arthritis, pain and inflammatory
diseases. For more information, please visit www.horizonpharma.com.
This press release contains
forward-looking statements, including statements regarding whether
the FDA is prevented from approving WLF's ANDA filing until a future
time. These forward-looking statements are based on management's
expectations and assumptions as of the date of this press release,
and actual results may differ materially from those in these
forward-looking statements as a result of various factors. These
factors include, but are not limited to, whether Horizon would be
successful in the patent infringement litigation. For a further
description of these and other risks facing Horizon, please see the
risk factors described in Horizon's filings with the United States
Securities and Exchange Commission, including those factors discussed
under the caption "Risk Factors" in those filings. Forward-looking
statements speak only as of the date of this press release, and
Horizon undertakes no obligation to update or revise these
statements, except as may be required by law.
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
Burns McClellan, Inc.
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