Cadence Pharmaceuticals Announces Settlement of OFIRMEV® (Acetaminophen) Injection Patent Litigation with Perrigo Company

   Cadence Pharmaceuticals Announces Settlement of OFIRMEV® (Acetaminophen)
               Injection Patent Litigation with Perrigo Company

PR Newswire

SAN DIEGO, Nov. 28, 2012

SAN DIEGO, Nov. 28, 2012 /PRNewswire/ -- Cadence Pharmaceuticals, Inc.
(Nasdaq: CADX) today announced that it has entered into settlement and license
agreements with Perrigo Company (Nasdaq: PRGO; TASE), and its subsidiary,
Paddock Laboratories, LLC, to resolve pending patent litigation involving
OFIRMEV® (acetaminophen) injection.

The settlement agreement includes a stipulation by the parties requesting
dismissal with prejudice of the lawsuit filed by Cadence in the U.S. District
Court for the District of Delaware relating to the Abbreviated New Drug
Application, or ANDA, filed by Paddock with the U.S. Food and Drug
Administration for a generic version of OFIRMEV® (acetaminophen) injection.
Litigation remains ongoing against Exela Pharma Sciences, LLC, Exela
PharmaSci, Inc. and Exela Holdings, Inc.

Under the license agreement, Perrigo has been granted the exclusive right of
first refusal to negotiate an agreement with Cadence to market an authorized
generic version of OFIRMEV (i.e., a generic version marketed under Cadence's
New Drug Application) in the U.S., in the event that Cadence elects to launch
an authorized generic version of the product. Additionally, Cadence has
granted Perrigo the non-exclusive right to market a generic intravenous
acetaminophen product in the U.S. under Perrigo's ANDA, after December 6,
2020, or earlier under certain circumstances. Currently, Cadence has listed
two Orange Book patents covering OFIRMEV, the last of which, U.S. Patent No.
6,992,218, will expire on June 6, 2021, or December 6, 2021, if pediatric
exclusivity is granted.

The license agreement also provides that, if the parties enter into an
agreement for Perrigo to market an authorized generic version of OFIRMEV,
during the license period, Perrigo would purchase the product exclusively from
Cadence. Cadence would receive product costs plus an administrative fee, as
well as a royalty payment based on the net profits achieved by Perrigo from
the sale of the authorized generic product. Other details of the settlement
are confidential, and the agreements are subject to submission to the Federal
Trade Commission and the U.S. Department of Justice. The settlement and
license agreements will become effective upon the entry by the U.S. District
Court for the District of Delaware of an order dismissing with prejudice the
litigation with respect to Perrigo.

"This settlement validates our confidence in the integrity of the patents
covering OFIRMEV," said Ted Schroeder, President and CEO of Cadence. "We
believe that OFIRMEV is an important medication for managing pain and fever in
hospitalized patients, and we look forward to years of continued growth in
sales of this product."

About OFIRMEV^® (Acetaminophen) Injection

OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for
intravenous use only), Cadence Pharmaceuticals' proprietary intravenous
formulation of acetaminophen, is indicated for the management of mild to
moderate pain, the management of moderate to severe pain with adjunctive
opioid analgesics, and the reduction of fever. The FDA approval of OFIRMEV was
based on data from clinical trials in approximately 1,020 adult and 355
pediatric patients. These trials included two studies evaluating the safety
and effectiveness of OFIRMEV in the treatment of pain, and one study
evaluating OFIRMEV in the treatment of fever. The effectiveness of OFIRMEV for
the treatment of acute pain and fever has not been studied in pediatric
patients less than 2 years of age.

Important Safety Information

Do not exceed the maximum recommended daily dose of acetaminophen.
Administration of acetaminophen by any route in doses higher than recommended
may result in hepatic injury, including the risk of severe hepatotoxicity and
death. OFIRMEV is contraindicated in patients with severe hepatic impairment,
severe active liver disease or with known hypersensitivity to acetaminophen or
to any of the excipients in the formulation. Acetaminophen should be used with
caution in patients with the following conditions: hepatic impairment or
active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia,
or severe renal impairment.OFIRMEV should be administered only as a 15-minute
intravenous infusion. Discontinue OFIRMEV immediately if symptoms associated
with allergy or hypersensitivity occur. Do not use in patients with
acetaminophen allergy. The most common adverse reactions in patients treated
with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients
and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in
pediatric patients. The antipyretic effects of OFIRMEV may mask fever in
patients treated for post-surgical pain.

For more information, please see the complete OFIRMEV Prescribing Information,
available at www.OFIRMEV.comor www.cadencepharm.com.

About Cadence Pharmaceuticals, Inc.

Cadence Pharmaceuticals is a biopharmaceutical company focused on acquiring,
in-licensing, developing and commercializing proprietary products principally
for use in the hospital setting. The current version of Cadence
Pharmaceuticals' corporate overview may be viewed on the Investors page of
www.cadencepharm.com under "Events & Presentations" by selecting "Corporate
Overview."

Forward-Looking Statements

Statements included in this press release that are not a description of
historical facts are forward-looking statements. Words such as "plans,"
"believes," "expects," "anticipates," and "will," and similar expressions, are
intended to identify forward-looking statements, and are based on Cadence's
current beliefs and expectations. Such statements include, without limitation,
statements regarding the potential for approval of the settlement terms by the
U.S. District Court for the District of Delaware, the Federal Trade Commission
and the U.S. Department of Justice; our confidence in the strength of the
patents covering OFIRMEV and the prospects for future growth in sales of the
product; and the prospect of Cadence receiving payments from Paddock,
including product costs, an administrative fee and royalty payments. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. Cadence's actual future results may
differ materially from Cadence's current expectations due to the risks and
uncertainties inherent in its business. These risks include, but are not
limited to: Cadence's dependence on the successful commercialization of
OFIRMEV, which is currently the company's only product, including its ability
to achieve broad market acceptance and generate revenues from sales of
OFIRMEV; Cadence's ability to successfully enforce its marketing exclusivities
and intellectual property rights, and to defend the patents covering OFIRMEV,
including in current patent litigation with Exela Pharma Sciences, LLC, Exela
PharmaSci, Inc. and Exela Holdings, Inc., or collectively, Exela; the
potential that Cadence may be required to continue patent litigation for
substantial lengths of time, file additional lawsuits to defend its patent
rights from challenges by Exela or other companies that may submit ANDAs for
generic versions of OFIRMEV, and the substantial costs associated with such
lawsuits; the potential that the United States Patent and Trademark Office, or
USPTO, may not prevail in a lawsuit filed against it earlier this year by
Exela in the United States District Court for the Eastern District of
Virginia, in which Exela seeks a reversal of the USPTO's decision to refuse to
act on a petition by Exela to vacate the USPTO's April 2003 order reviving the
international application for U.S. Patent No. 6,992,218; the potential that
the USPTO may grant an ex parte request for the reexamination of U.S. Patent
No. 6,028,222, and that, as a result of such reexamination, claims in that
patent may be invalidated or narrowed in scope; the potential introduction of
generic competition to OFIRMEV in the event Cadence is unsuccessful in current
or future patent litigation; Cadence's dependence on its licensors for the
maintenance and enforcement of its intellectual property rights; the potential
product liability exposure associated with pharmaceutical products such as
OFIRMEV and other products Cadence may in-license or acquire; Cadence's
ability to ensure an adequate and continued supply of OFIRMEV to meet
anticipated market demand; and the risk that Cadence may not be able to raise
sufficient capital when needed, or at all; and other risks detailed under
"Risk Factors" and elsewhere in Cadence's periodic reports and other filings
made with the SEC from time to time. All forward-looking statements are
qualified in their entirety by this cautionary statement, which is made under
the safe harbor provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995, and the company undertakes no obligation to revise or
update this press release to reflect events or circumstances after the date
hereof.

Cadence^® and OFIRMEV^® are trademarks of Cadence Pharmaceuticals, Inc.

Contact: William R. LaRue              Kelli France
         SVP & Chief Financial Officer Media Relations
         Cadence Pharmaceuticals, Inc. WCG
         Phone: 858-436-1400           Phone: 415-946-1076

SOURCE Cadence Pharmaceuticals, Inc.

Website: http://www.cadencepharm.com
 
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