Collaboration agreement between Mallinckrodt and Horizon Pharma on
NSAID/H2 Combination
HAZELWOOD, Mo.--(BUSINESS WIRE)--Jun. 18, 2012--
Mallinckrodt, the Pharmaceuticals business of Covidien
(NYSE: COV), today announced that it has entered into a co-promotion
agreement with Horizon Pharma, Inc. (NASDAQ: HZNP) to promote DUEXIS®
(ibuprofen and famotidine). DUEXIS is a proprietary single-tablet
combination of the non-steroidal anti-inflammatory drug ibuprofen and
the histamine H2-receptor antagonist famotidine and is indicated for the
relief of signs and symptoms of rheumatoid arthritis and osteoarthritis
and to decrease the risk of developing upper gastrointestinal ulcers.
Under the terms of the agreement, Mallinckrodt’s U.S. sales force will
sell DUEXIS through December 31, 2014. Horizon and Mallinckrodt have
agreed upon physician promotion targets and Mallinckrodt will be
compensated for each prescription generated from these targets. The
Mallinckrodt sales force is expected to begin promoting DUEXIS to
physicians in August 2012. Horizon will continue to record all revenues
and remain responsible for DUEXIS manufacturing, supply and regulatory
activities.
"This agreement represents a key component of our growing
pharmaceuticals business as Mallinckrodt prepares to spin off from
Covidien next year,” said Mark Trudeau, President, Pharmaceuticals. “We
are leaders in pain management, and adding DUEXIS to our portfolio will
further advance our efforts to help patients manage the
often-debilitating impact of pain. We look forward to working with
Horizon and providing DUEXIS to our customers.”
“The addition of Mallinckrodt’s experienced sales force will expand our
reach and frequency into the osteoarthritis and rheumatology markets,”
said Timothy P. Walbert, Chairman, President and Chief Executive
Officer, Horizon Pharma.
Mallinckrodt is the largest U.S. supplier of opioid pain medications and
among the top 10 generic pharmaceuticals manufacturers in the U.S.,
based on prescriptions. Its branded portfolio includes EXALGO®
(hydromorphone HCl) Extended-Release Tablets (CII) and PENNSAID®
(diclofenac sodium topical solution) 1.5% w/w. Mallinckrodt is also one
of the world’s leading producers of bulk acetaminophen.
Covidien announced last December that the Company planned to spin off
Mallinckrodt into a stand-alone company, a process that is expected to
be completed in mid-2013.
IMPORTANT RISK INFORMATION
About PENNSAID:
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Cardiovascular Risk
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• Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an
increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of use. Patients with cardiovascular disease
or risk factors for cardiovascular disease may be at greater risk.
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• PENNSAID is contraindicated in the perioperative setting of
coronary artery bypass graft (CABG) surgery.
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Gastrointestinal Risk
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• NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding, ulceration, and perforation of the
stomach or intestines, which can be fatal. These events can occur at
any time during use and without warning symptoms. Elderly patients
are at greater risk for serious gastrointestinal events.
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About EXALGO:
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WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT
SELECTION
AND LIMITATIONS OF USE
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Potential for Abuse
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EXALGO contains hydromorphone, an opioid agonist and a Schedule
II controlled substance with an abuse liability similar to other
opioid analgesics. EXALGO can be abused in a manner similar to
other opioid agonists, legal or illicit. These risks should be
considered when administering, prescribing, or dispensing EXALGO
in situations where the healthcare professional is concerned about
increased risk of misuse, abuse, or diversion. Schedule II opioid
substances which include hydromorphone, morphine, oxycodone,
fentanyl, oxymorphone and methadone have the highest potential for
abuse and risk of fatal overdose due to respiratory depression.
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Proper Patient Selection
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EXALGO is an extended-release formulation of hydromorphone
hydrochloride indicated for the management of moderate to severe
pain in opioid tolerant patients when a continuous
around-the-clock opioid analgesic is needed for an extended period
of time. Patients considered opioid tolerant are those who are
taking at least 60 mg oral morphine per day, 25 mcg transdermal
fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral
hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic
dose of another opioid, for a week or longer.
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EXALGO is for use in opioid tolerant patients only.
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Fatal respiratory depression could occur in patients who are
not opioid tolerant.
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Accidental consumption of EXALGO, especially in children, can
result in a fatal overdose of hydromorphone.
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Limitations of Use
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EXALGO is not indicated for the management of acute or
postoperative pain.
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EXALGO is not intended for use as an as-needed analgesic.
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EXALGO tablets are to be swallowed whole and are not to be
broken, chewed, dissolved, crushed or injected. Taking broken,
chewed, dissolved or crushed EXALGO or its contents leads to rapid
release and absorption of a potentially fatal dose of
hydromorphone.
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ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien manufactures,
distributes and services a diverse range of industry-leading product
lines in three segments: Medical Devices, Pharmaceuticals and Medical
Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000
employees worldwide in more than 65 countries, and its products are sold
in over 140 countries. Mallinckrodt, the Pharmaceuticals business of
Covidien, manufactures active pharmaceutical ingredients, including bulk
acetaminophen, opioid pain medications, nuclear and contrast media
diagnostic agents. Sales in 2011 were $2.0 billion. Please visit www.covidien.com
to learn more about our business.
EXALGO is a registered trademark of Mallinckrodt LLC. PENNSAID is a
registered trademark of Nuvo Research Inc.
DUEXIS is a registered trademark of Horizon Pharma USA, Inc.
Source: Covidien
Covidien
Lynn Phillips, 314-654-3263
Manager, Media Relations
Pharmaceuticals
lynn.phillips@covidien.com
or
Coleman
Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Stephen
Littlejohn, 314-654-6595
Vice President Communications
Pharmaceuticals
stephen.littlejohn@covidien.com
or
Todd
Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com
