News Release
Mallinckrodt Pharmaceuticals Announces Settlement of OFIRMEV® (acetaminophen) Injection Patent Litigation with Fresenius Kabi USA, LLC
ST. LOUIS--(BUSINESS WIRE)--Aug. 6, 2014--
Mallinckrodt
plc (NYSE: MNK) today announced that its subsidiary, Cadence
Pharmaceuticals, Inc., has entered into settlement and license
agreements with Fresenius Kabi USA, LLC, resolving pending patent
litigation involving OFIRMEV® (acetaminophen) injection.
The companies are not disclosing specific terms of the settlement and
license agreements, except that Cadence has granted Fresenius Kabi a
non-exclusive right to market an intravenous acetaminophen product in
the U.S. under Fresenius Kabi’s 505(b)(2) New Drug Application on
December 6, 2020, or earlier under certain circumstances. Mallinckrodt’s
subsidiary Cadence has two patents covering OFIRMEV listed in the Orange
Book, the last of which, U.S. Patent No. 6,992,218, will expire on June
6, 2021. Cadence had filed suit against Fresenius Kabi in January 2013.
Other details of the settlement are confidential, and the settlement is
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 of an order
dismissing with prejudice the litigation with respect to Fresenius Kabi.
"This settlement validates our confidence in the strength and integrity
of the intellectual property covering OFIRMEV," said Mark Trudeau,
President and CEO, Mallinckrodt. “OFIRMEV represents a powerful growth
product in our expanding portfolio, and we look forward to continuing
the strong presence that has been established by this brand in the
hospital market.”
OFIRMEV (acetaminophen) injection 100 mL vials, 1000 mg (10 mg/mL)
INDICATIONS AND USAGE
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.
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.
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 (e.g., due to
dehydration or blood loss), 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.
-
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.
-
The antipyretic effects of OFIRMEV may mask fever.
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.
USE IN SPECIFIC POPULATIONS
-
Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant
woman only if clearly needed.
-
Breast Feeding: While studies with OFIRMEV have not been conducted,
acetaminophen is secreted in human milk in small quantities after oral
administration.
-
Pediatrics: The effectiveness of OFIRMEV for the treatment of acute
pain and fever has not been studied in pediatric patients < 2 years of
age.
See Full
Prescribing Information for additional Important Risk
Information including boxed warning.
About Mallinckrodt
Mallinckrodt is a global specialty pharmaceutical and medical imaging
business that develops, manufactures, markets and distributes specialty
pharmaceutical products and medical imaging agents. The company’s core
strengths include the acquisition and management of highly regulated raw
materials; deep regulatory expertise; and specialized chemistry,
formulation and manufacturing capabilities. The company’s Specialty
Pharmaceuticals segment includes branded and specialty generic drugs and
active pharmaceutical ingredients, and the Global Medical Imaging
segment includes contrast media and nuclear imaging agents. Mallinckrodt
has approximately 5,500 employees worldwide and a commercial presence in
approximately 65 countries. The company’s fiscal 2013 revenue totaled
$2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Cautionary Statements Related to Forward-Looking Statements
Statements in this document that are not strictly historical, including
statements regarding the proposed acquisition, the expected timetable
for completing the transaction, future financial and operating results,
benefits and synergies of the transaction, future opportunities for the
combined businesses and any other statements regarding events or
developments that we believe or anticipate will or may occur in the
future, may be “forward-looking” statements within the meaning of the
Private Securities Litigation Reform Act of 1995, and involve a number
of risks and uncertainties. There are a number of important factors that
could cause actual events to differ materially from those suggested or
indicated by such forward-looking statements and you should not place
undue reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things: general
economic conditions and conditions affecting the industries in which
Mallinckrodt and Questcor operate; the commercial success of
Mallinckrodt’s and Questcor’s products, including H.P. Acthar®
Gel; Mallinckrodt’s and Questcor’s ability to protect intellectual
property rights; the parties’ ability to satisfy the merger agreement
conditions and consummate the merger on the anticipated timeline or at
all; the availability of financing, including the financing contemplated
by the debt commitment letter, on anticipated terms or at all;
Mallinckrodt’s ability to successfully integrate Questcor’s operations
and employees with Mallinckrodt’s existing business; the ability to
realize anticipated growth, synergies and cost savings; Questcor’s
performance and maintenance of important business relationships; the
lack of patent protection for Acthar, and the possible United States
Food and Drug Administration (“FDA”) approval and market introduction of
additional competitive products; Questcor’s reliance on Acthar for
substantially all of its net sales and profits; Questcor’s ability to
continue to generate revenue from sales of Acthar to treat on-label
indications associated with nephrotic syndrome, multiple sclerosis,
infantile spasms or rheumatology-related conditions, and Questcor’s
ability to develop other therapeutic uses for Acthar; volatility in
Questcor’s Acthar shipments, estimated channel inventory, and end-user
demand; an increase in the proportion of Questcor’s Acthar unit sales
comprised of Medicaid-eligible patients and government entities;
Questcor’s research and development risks, including risks associated
with Questcor’s work in the areas of nephrotic syndrome and lupus, and
Questcor’s efforts to develop and obtain FDA approval of Synacthen™
Depot; Mallinckrodt’s ability to receive procurement and production
quotas granted by the U.S. Drug Enforcement Administration;
Mallinckrodt’s ability to obtain and/or timely transport molybdenum-99
to its technetium-99m generator production facilities; customer
concentration; cost-containment efforts of customers, purchasing groups,
third-party payors and governmental organizations; Mallinckrodt’s
ability to successfully develop or commercialize new products;
competition; Mallinckrodt’s ability to achieve anticipated benefits of
price increases; Mallinckrodt’s ability to integrate acquisitions of
technology, products and businesses generally; product liability losses
and other litigation liability; the reimbursement practices of a small
number of large public or private issuers; complex reporting and payment
obligations under healthcare rebate programs; changes in laws and
regulations; conducting business internationally; foreign exchange
rates; material health, safety and environmental liabilities; litigation
and violations; information technology infrastructure; and restructuring
activities. Additional information regarding the factors that may cause
actual results to differ materially from these forward-looking
statements is available in (i) Mallinckrodt’s SEC filings, including its
Annual Report on Form 10-K for the fiscal year ended September 27, 2013,
its Quarterly Report on Form 10-Q for the quarterly period ended
December 27, 2013 and its Quarterly Report on Form 10-Q for the
quarterly period ended March 28, 2014; (ii) the SEC filings of Cadence
Pharmaceuticals, Inc., which was acquired by Mallinckrodt on March 19,
2014, including its Annual Report on Form 10-K for the fiscal year ended
December 31, 2013; and (iii) Questcor’s SEC filings, including its
Annual Report on Form 10-K for the year ended December 31, 2013 (and the
amendment thereto on Form 10-K/A), its Quarterly Report on Form 10-Q for
the quarterly period ended March 31, 2014, and its Current Report on
Form 8-K filed with the SEC on July 10, 2014. The forward-looking
statements made herein speak only as of the date hereof and none of
Mallinckrodt, Questcor or any of their respective affiliates assumes any
obligation to update or revise any forward-looking statement, whether as
a result of new information, future events and developments or
otherwise, except as required by law.
Source: Mallinckrodt plc
Mallinckrodt plc
John Moten, 314-654-6650
Vice President,
Investor Relations
john.moten@mallinckrodt.com
or
Lynn
Phillips, 314-654-3263
Manager, Communications
lynn.phillips@mallinckrodt.com
or
Meredith
Fischer, 314-654-6595
Senior Vice President, Communications
meredith.fischer@mallinckrodt.com