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OFIRMEV® (Acetaminophen) Injection Health Economic Data Presented and Specially Recognized at Annual Congress of Enhanced Recovery and Perioperative Medicine

-- Retrospective data show decrease in hospitalization costs when treating
acute postoperative orthopedic surgical pain with OFIRMEV as part of multimodal analgesia compared to IV opioids alone --

CHESTERFIELD, United Kingdom – April 25, 2016 - Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced the results from a retrospective analysis of health economic data on the use of OFIRMEV (acetaminophen) injection as part of multimodal analgesia (MMA) for the treatment of acute postoperative pain following elective orthopedic surgery. The analysis, recognized as a top-scoring abstract during the peer-review process, was one of four selected for oral presentation and identified as an award recipient at the 2016 Annual Congress of Enhanced Recovery and Perioperative Medicine on Thursday, April 21, in Washington, DC.

The Mallinckrodt-sponsored study, "Hospitalization Costs for Patients Undergoing Orthopedic Surgery Treated with Intravenous Acetaminophen (IV-APAP) Plus Other IV Analgesics or IV Opioids Alone for Postoperative Pain," evaluated data from Truven Health's MarketScan Hospital Drug Database (HDD) of approximately 600 participating hospitals and included more than 144,000 patients admitted and discharged for elective orthopedic surgery between Jan. 1, 2011 and Aug. 31, 2014. The retrospective analysis assessed hospitalization costs (medical plus pharmacy) among patients undergoing elective total knee replacement, total hip replacement or surgical repair of hip fracture who received multimodal postoperative pain management with the combination of OFIRMEV and other IV analgesics to those who received only IV opioids starting on the day of surgery. Both groups could receive oral analgesics as part of their postoperative pain management regimen. Though treatment groups were significantly different on all baseline characteristics (all P<0.001), including mean age, percent female and if the hospital was a teaching hospital, the numerical differences observed between groups may not be clinically meaningful.

Key findings associated with the use of multimodal analgesia, including OFIRMEV, versus IV opioids alone in the orthopedic postsurgical pain management setting were:

  • Statistically significantly lower mean total hospitalization costs for patients in the OFIRMEV group compared to patients in the IV opioid-only group ($12,540 vs. $13,242; P<0.0001); and
  • The difference in total costs was driven by lower medical costs such as reduced medical and surgical supplies, laboratory testing, imaging and other costs, which made up $701 of the $702 difference.
  • Differences in hospitalization costs remained statistically significant after controlling for baseline differences in the multivariate analysis, with use of OFIRMEV as part of a multimodal analgesia approach associated with $830 less in hospitalization costs (P<0.0001).

LIMITATIONS OF STUDY

  • Only patients admitted to hospitals providing cost data to the HDD are included; therefore, results seen in this analysis may not be generalizable outside of Truven Health's MarketScan, which represents only 11% of all hospitals in the U.S.
  • Analyses were limited to data collected through hospital billing systems; data obtained outside the hospital setting are not included.
  • Cost analyses were conducted at the hospital discharge level, so if a patient was admitted to two or more different hospitals during the study period, each admission would be considered a unique discharge.

ABOUT THE DATA
Hospitalization Costs for Patients Undergoing Orthopedic Surgery Treated with Intravenous Acetaminophen (IV-APAP) Plus Other IV Analgesics or IV Opioids Alone for Postoperative Pain. Manasee V. Shah, MPH, Xcenda, Palm Beach, FL.

Abstract available online (Pg. 34): http://aserhq.org/wp-content/uploads/2016/04/ASER_Syllabus_16_web.pdf

IMPLICATIONS OF THE DATA
This analysis may offer important insight on possible ways to help provide savings to the hospital system and improve patient outcomes in the orthopedic surgical setting. These findings support a similar retrospective study in the orthopedic patient population that showed multimodal analgesia with OFIRMEV also helped improve patient outcomes and solutions to contain costs.1 The use of opioids alone has been a mainstay for acute pain management. There is an overreliance on opioids as monotherapy to treat acute pain in U.S. hospitals today and 7 out of 10 hospital patients treated with IV analgesia receive IV opioids alone.2

ABOUT OFIRMEV (Acetaminophen) Injection
OFIRMEV (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever. OFIRMEV (acetaminophen) injection is the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration approved OFIRMEV in November 2010. OFIRMEV is available to hospitals and outpatient and ambulatory surgical centers across the U.S.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:     

     
  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.


CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with:
    • known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.
    • severe hepatic impairment or severe active liver disease.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.


For additional Important Risk Information, including complete boxed warning, see Full Prescribing Information.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CONTACTS

Media
Rhonda Sciarra
Senior Communications Manager
314-654-8618
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Senior Vice President, Communications and Public Affairs
314-654-3318
meredith.fischer@mallinckrodt.com

Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com

1Apfel C, et al. Effect of i.v. acetaminophen on total hip or knee replacement surgery: A case-matched evaluation
of a national patient database. Am J Health-Syst Pharm. 2015; 72:1961-8.

2 Premier Healthcare Alliance [paid-access hospital research database: data from January 2011-March 2015]. Charlotte, NC: Premier, Inc. Updated June 2015.