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Mallinckrodt Statement on Sen. Mccaskill Inquiry Related to Ofirmev® (Acetaminophen) Injection

May 26, 2017

Mallinckrodt confirmed receipt of a request for information from U.S. Sen. Claire McCaskill of Missouri, Ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee. The Senator’s inquiry relates to OFIRMEV® (acetaminophen) injection, a patented, intravenous form of acetaminophen. OFIRMEV is an effective, non-opioid analgesic used to manage acute pain that, in addition to reducing pain, is proven to significantly reduce opioid consumption across various surgical settings.¹,²,³,⁴,⁵

Retrospective studies suggest use of OFIRMEV may be associated with reduced costs to the hospital system and may help improve certain patient outcomes.⁶,⁷,⁸   One recent analysis of health economic data on the use of OFIRMEV coupled with a one-level reduction in opioid use was linked to decreasing hospital stays, potential opioid-related complications and related costs for the treatment of acute surgical pain. The study showed a potential of $4.7 million in annual savings for a typical, medium-sized hospital.⁹  Additional information on other analyses may be found at Mallinckrodt.com in the News section. The clinical benefit of reduced opioid consumption with OFIRMEV has not been evaluated nor demonstrated in prospective, randomized controlled trials.

Mallinckrodt has previously met with and provided information to the Senator’s staff on OFIRMEV. We will continue to work with Sen. McCaskill and her staff to assure the clinical and economic value of OFIRMEV is well understood.

OFIRMEV Ownership, Pricing and Investment
OFIRMEV became part of Mallinckrodt’s portfolio in March 2014, through the acquisition of Cadence Pharmaceuticals. At that time, OFIRMEV, the only product owned by Cadence had, for several years, been losing tens of millions of dollars annually, as reflected in Cadence’s public filings with the Securities and Exchange Commission.¹⁰ In May 2014, Mallinckrodt sought to stabilize OFIRMEV’s financial situation by increasing the drug’s list price from $14.75 per vial to $35.40 per vial, not including significant customer discount opportunities.
To put that price into context, often the quantity used for a patient undergoing a surgical procedure for which OFIRMEV is appropriate is fewer than four vials or currently around $150 in cost, not including discounts. (A full case of OFIRMEV includes 24 vials.) In contrast, public data indicates that the average payment a hospital receives for these types of surgeries can rise to tens of thousands of dollars per episode.

Since owning the product, Mallinckrodt has made significant investments to support and demonstrate OFIRMEV’s value, including completing more than half a dozen retrospective health economic and outcomes research studies to provide additional insight for clinicians, pharmacists and hospital administrators on the value of OFIRMEV in acute pain management in the surgical setting. These studies reinforce Mallinckrodt’s commitment to providing hospital customers with high-value products that address the clinical needs of patients.

The company is also launching an innovative “Prove It Out” demonstration program that provides OFIRMEV at a significantly discounted price, enabling hospitals to utilize their own experience to demonstrate the benefits and value of the medicine, including potentially reducing hospital lengths of stay. Moreover, Mallinckrodt’s contracting strategy provides strong incentives to hospitals, where greater discounts are associated with increasing OFIRMEV use and reducing opioid use.

Since the necessary 2014 price reset, any price increases for OFIRMEV have been aligned with Mallinckrodt’s Pledge on Drug Pricing and Innovation, which governs our pricing decisions and can be found here: http://www.mallinckrodt.com/corporate-responsibility/drug-pricing-innovation.

Mallinckrodt’s Role in the Fight Against Opioid Abuse and Misuse
The opioid epidemic is a complex and confounding problem, and no one policy initiative or program will solve it. Mallinckrodt has invested millions of dollars in its comprehensive program to address opioid abuse and misuse. For multiple years, Mallinckrodt has been a vocal advocate for the prescription drug monitoring program in Missouri. The company purchased and donated more than 1.5 million drug deactivation pouches distributed in our communities in Missouri and across the U.S. so that families can actively address concerns with the responsible use of pain medications and patient safety.

We work with law enforcement to help prevent misuse and diversion, including by providing no-cost placebo tablets of Mallinckrodt opioids to officers and prosecutors for use in law enforcement operations; attacking drug theft through tracking devices in selected Mallinckrodt drug bottles; and contributing testimony on behalf of prosecution in drug diversion cases. We also helped to found the Anti-Diversion Industry Working Group, a collective of leading manufacturers and distributors of pharmaceutical controlled substances coming together to collaborate and share best practices with the purpose of exceeding U.S. Drug Enforcement Administration obligations for opioid anti-diversion programs.

To truly make an impact on opioid abuse, all stakeholders must better understand the various interrelated causes and contributors to the problem, and work together to address all of them in a comprehensive, thoughtful manner. We continue to work to be part of the solution.

ABOUT OFIRMEV (Acetaminophen) Injection
OFIRMEV is the first and only IV formulation of acetaminophen to be approved and currently marketed 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.

INDICATIONS AND USAGE
OFIRMEV®(acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY 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.

Please see additional Important Safety Information, including Boxed Warning, in the Full Prescribing Information, which can also be found at OFIRMEV.com.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

• Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
• Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
• Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately at the first sign of skin rash.
• Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
• Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
• The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

• Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.

• The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

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 products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products. 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 and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. 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 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

Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com 
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com