Press Release

Mallinckrodt Announces Co-Promotion Arrangement for DUEXIS®

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.



Cardiovascular Risk
• 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.

• PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

• 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.




Potential for Abuse

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.


Proper Patient Selection

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.


EXALGO is for use in opioid tolerant patients only.


Fatal respiratory depression could occur in patients who are not opioid tolerant.


Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.


Limitations of Use

EXALGO is not indicated for the management of acute or postoperative pain.


EXALGO is not intended for use as an as-needed analgesic.


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.



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 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

Lynn Phillips, 314-654-3263
Manager, Media Relations
Coleman Lannum, CFA, 508-452-4343
Vice President
Investor Relations
Stephen Littlejohn, 314-654-6595
Vice President Communications
Todd Carpenter, 508-452-4363
Investor Relations