Mallinckrodt Pharmaceuticals to Present Data for Investigational and Approved Extended-Release Opioid Combination Medicines at

  Mallinckrodt Pharmaceuticals to Present Data for Investigational and
  Approved Extended-Release Opioid Combination Medicines at PAINWeek

Data describe human abuse liability, release profile, efficacy and safety for
     MNK-155 and safety and pharmacokinetics for XARTEMIS™ XR (oxycodone
       hydrochloride and acetaminophen) Extended-Release Tablets (CII)

Business Wire

ST. LOUIS -- August 28, 2014

Mallinckrodt (NYSE: MNK) today announced that clinical data for its
investigational opioid, MNK-155 (hydrocodone bitartrate and acetaminophen) and
approved opioid combination product XARTEMIS™ XR (oxycodone hydrochloride and
acetaminophen) Extended-Release Tablets (CII) will be presented at PAINWeek
2014, a national conference on pain for frontline practitioners, September
2-6, in Las Vegas, Nevada.

MNK-155 is an investigational extended-release oral formulation of hydrocodone
and acetaminophen being studied for the management of moderate to moderately
severe acute pain where the use of an opioid analgesic is appropriate. MNK-155
is formulated with both immediate- and extended-release components. The NDA
for MNK-155 was accepted for review by the U.S. Food and Drug Administration
(FDA) in May 2014.

XARTEMIS XR, approved by the FDA in March 2014, is the first and only
immediate- and extended-release oral combination of two clinically proven pain
medications -- oxycodone and acetaminophen. It is indicated for the management
of acute pain severe enough to require opioid treatment and for which
alternative treatment options (e.g., non-opioid analgesics) are ineffective,
not tolerated or would otherwise be inadequate. XARTEMIS XR is formulated with
both immediate- and extended-release components to provide onset of pain
relief in less than one hour and to allow twice daily dosing. Other than
XARTEMIS XR, currently available commonly used oral acute pain options
containing an opioid are dosed every 4 to 6 hours.

XARTEMIS XR research presented at the meeting includes pooled safety data from
Phase 3 clinical trials and describes the pharmacokinetics in various
populations and the potential impact on dosing for clinical practice. Clinical
data for MNK-155 include results from a Human Abuse Liability (HAL) study to
evaluate the extent to which MNK-155 intact or crushed versus
immediate-release hydrocodone-acetaminophen produce certain subjective effects
that have been associated with drug abuse in recreational opioid users, such
as drug-liking, high, and good drug effects. Efficacy, safety and
pharmacokinetic study results will also be presented.

“Since acute pain can have a profound impact on a person’s life, opioid
combination treatments dosed every four to six hours may pose difficulties for
some patients, such as the sleep disruption that can be caused by a 4-6 hour
dosing interval. That is why Mallinckrodt is committed to developing and
providing patients and physicians with longer-lasting treatment options,” said
Mark Trudeau, President and CEO of Mallinckrodt. “The data we are presenting
at PAINWeek will help clinicians gain insight into the efficacy,
pharmacokinetics, release characteristics and implications of the
drug-delivery technology for these extended-release opioid combinations.”

Research to be presented at the meeting for MNK-155 and XARTEMIS XR is as
follows:

MNK-155 abstracts

  *Comparison of Subjective Drug Effects of Orally Administered MNK-155
    Extended-Release Hydrocodone Bitartrate/Acetaminophen (HB/APAP ER) Tablets
    versus Immediate-Release Hydrocodone Bitartrate/Acetaminophen Tablets in
    Recreational Users of Prescription Opioids
  *Influence of Pharmacokinetic Differences on Pharmacodynamic Measures of
    Abuse Liability: Comparison of MNK-155 Extended-Release Hydrocodone
    Bitartrate/Acetaminophen Tablets and Immediate-Release Hydrocodone
    Bitartrate/Acetaminophen Tablets in Recreational Users of Prescription
    Opioids
  *Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety
    and Analgesic Efficacy of MNK-155, Extended-Release hydrocodone
    Bitartrate/Acetaminophen Tablets, in an Acute Pain Model
  *Open-Label Safety of MNK-155, Extended-Release Hydrocodone
    Bitartrate/Acetaminophen Tablets (HB/APAP ER), in Patients with
    Osteoarthritis or Chronic Low Back Pain
  *Single- and Multiple-Dose Pharmacokinetics of Extended-Release Hydrocodone
    Bitartrate/Acetaminophen Tablets (MNK-155) With and Without Loading Dose
    Compared With Marketed Immediate-Release Hydrocodone Bitartrate/Ibuprofen
    Tablets and Immediate-Release Tramadol HCI/Acetaminophen Tablets
  *Single- and Multiple-Dose Pharmacokinetics of 1 and 2 Tablets of
    Extended-Release Hydrocodone Bitartrate/Acetaminophen (MNK-155) Compared
    With Immediate-Release Hydrocodone Bitartrate/Acetaminophen
  *Single-Dose Pharmacokinetics of 2 or 3 Tablets of Extended-Release
    Hydrocodone Bitartrate/ Acetaminophen (MNK-155) Under Fed and Fasted
    Conditions

XARTEMIS XR abstracts

  *Safety and Tolerability of Extended-Release Oxycodone/Acetaminophen
    Tablets in Phase 3 Clinical Trials
  *Respiratory Rates and O[2] Saturation After Administration of MNK-795
    (Oxycodone/Acetaminophen Extended-Release Tablets)
  *Population Pharmacokinetics of Oxycodone and Acetaminophen Following
    Multiple Oral Doses of Extended-Release Oxycodone/Acetaminophen Tablets
  *Population Pharmacokinetics of Oxycodone and Acetaminophen Following a
    Single Oral Dose of Extended-Release Oxycodone/Acetaminophen Tablets

XARTEMIS^™ XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, for
oral use, CII

INDICATIONS AND USAGE

XARTEMIS ^TM XR (oxycodone HCl and acetaminophen) Extended-Release Tablets
(CII) is indicated for the management of acute pain severe enough to require
opioid treatment and for which alternative treatment options are inadequate.
Because of the risks of addiction, abuse, misuse, overdose, and death with
opioids, even at recommended doses, reserve XARTEMIS XR for use in patients
for whom alternative treatment options (e.g., non-opioid analgesics) are
ineffective, not tolerated or would be otherwise inadequate.

IMPORTANT RISK INFORMATION

     WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
  DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and
                                HEPATOTOXICITY

Addiction, Abuse, and Misuse

XARTEMIS XR exposes patients and other users to the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death. Assess each patient’s
risk prior to prescribing XARTEMIS XR, and monitor all patients regularly for
the development of these behaviors or conditions.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use
of XARTEMIS XR. Monitor for respiratory depression, especially during
initiation of XARTEMIS XR or following a dose increase. Instruct patients to
swallow XARTEMIS XR tablets whole; crushing, chewing, or dissolving XARTEMIS
XR can cause rapid release and absorption of a potentially fatal dose of
oxycodone.

Accidental Exposure

Accidental ingestion of XARTEMIS XR, especially in children, can result in a
fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of XARTEMIS XR during pregnancy can result in neonatal opioid
withdrawal syndrome, which may be life-threatening if not recognized and
requires management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant woman, advise
the patient of the risk of neonatal opioid withdrawal syndrome and ensure that
appropriate treatment will be available.

Hepatotoxicity

XARTEMIS XR 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 maximum daily limit, and often involve
more than one acetaminophen-containing product.

CONTRAINDICATIONS

  *XARTEMIS XR is contraindicated in patients with:

       *known hypersensitivity to oxycodone, acetaminophen, or any other
         component of this product.
       *significant respiratory depression.
       *acute or severe bronchial asthma or hypercarbia.
       *known or suspected paralytic ileus.

WARNINGS AND PRECAUTIONS

  *XARTEMIS XR contains oxycodone, a Schedule II controlled substance. As an
    opioid, XARTEMIS XR exposes users to the risks of addiction, abuse, and
    misuse. Abuse or misuse of XARTEMIS XR by crushing, chewing, snorting, or
    injecting the dissolved product will result in the uncontrolled delivery
    of the oxycodone and can result in overdose and death. With intravenous
    abuse, the inactive ingredients in XARTEMIS XR can result in death, local
    tissue necrosis, infection, pulmonary granulomas, and increased risk of
    endocarditis and valvular heart injury. Parenteral drug abuse is commonly
    associated with transmission of infectious diseases such as hepatitis and
    HIV.

  *Serious, life-threatening, or fatal respiratory depression has been
    reported with the use of opioids, even when used as recommended. While
    serious, life-threatening, or fatal respiratory depression can occur at
    any time during the use of XARTEMIS XR, the risk is greatest during the
    initiation of therapy or following a dose increase. Life-threatening
    respiratory depression is more likely to occur in elderly, cachectic, or
    debilitated patients as they may have altered pharmacokinetics or altered
    clearance compared to younger, healthier patients. In patients with
    significant chronic obstructive pulmonary disease or cor pulmonale, and
    patients having a substantially decreased respiratory reserve, hypoxia,
    hypercapnia, or preexisting respiratory depression, XARTEMIS XR may
    decrease respiratory drive to the point of apnea.

  *Hypotension, profound sedation, coma, respiratory depression, and death
    may result if XARTEMIS XR is used concomitantly with alcohol or other
    central nervous system (CNS) depressants.
  *The risk of acute liver failure is higher in individuals with underlying
    liver disease and in individuals who ingest alcohol while taking
    acetaminophen.
  *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.
  *The respiratory depressant effects of narcotics and their capacity to
    elevate cerebrospinal fluid pressure may be markedly exaggerated in the
    presence of head injury, other intracranial lesions, or a pre-existing
    increase in intracranial pressure.
  *Oxycodone may cause severe hypotension particularly in individuals whose
    ability to maintain blood pressure has been compromised by a depleted
    blood volume, or after concurrent administration with drugs which
    compromise vasomotor tone such as phenothiazines.
  *Due to the potential for acetaminophen hepatotoxicity at doses higher than
    4000 milligrams/day, XARTEMIS XR should not be used concomitantly with
    other acetaminophen- containing products.
  *Hypersensitivity and anaphylaxis associated with use of acetaminophen have
    been reported. Clinical signs included swelling of the face, mouth, and
    throat, respiratory distress, urticaria, rash, pruritus, and vomiting.
  *Due to characteristics of the formulation that cause the tablets to swell
    and become sticky when wet, consider use of an alternative analgesic in
    patients who have difficulty swallowing and patients at risk for
    underlying GI disorders resulting in a small gastrointestinal lumen.
    Instruct patients not to pre-soak, lick or otherwise wet XARTEMIS XR
    tablets prior to placing in the mouth, and to take one tablet at a time
    with enough water to ensure complete swallowing immediately after placing
    in mouth.
  *Opioids diminish propulsive peristaltic waves in the gastrointestinal
    tract and decrease bowel motility. Oxycodone may cause spasm of the
    Sphincter of Oddi and should be used with caution in patients with biliary
    tract disease, including acute pancreatitis.
  *Since the CYP3A4 isoenzyme plays a major role in the metabolism of
    XARTEMIS XR, drugs that alter CYP3A4 activity may cause changes in
    clearance of oxycodone which could lead to changes in oxycodone plasma
    concentrations.
  *XARTEMIS XR may impair the mental and/or physical abilities required for
    the performance of potentially hazardous tasks such as driving a car or
    operating machinery. The patient using this drug should be cautioned
    accordingly.

ADVERSE REACTIONS

  *Serious adverse events may include respiratory depression and
    hepatotoxicity.
  *Common adverse events include nausea, dizziness, headache, vomiting,
    constipation and somnolence.

USE IN SPECIFIC POPULATIONS

  *Pregnancy: Opioids cross the placenta and may produce respiratory
    depression and psycho-physiologic effects in neonates. Prolonged use of
    XARTEMIS XR during pregnancy can result in withdrawal signs in the
    neonate, which can be life threatening.
  *Breast feeding: Oxycodone is present in human milk and may result in
    accumulation and toxicities such as sedation and respiratory depression in
    some infants. Acetaminophen is present in human milk in small quantities.
  *Pediatrics: Safety and effectiveness in pediatric patients under the age
    of 18 years have not been established.

See Full Prescribing Information for additional Important Risk Information
including boxed warning.

About XARTEMIS™ XR

XARTEMIS XR is an extended-release oral formulation of oxycodone hydrochloride
and acetaminophen with immediate-release and extended-release components. It
is not interchangeable with other oxycodone/acetaminophen products because of
differing pharmacokinetic profiles that affect the frequency of
administration. XARTEMIS XR is a schedule II controlled substance.

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. Areas of focus include therapeutic drugs
for autoimmune and rare disease specialty areas like neurology, rheumatology,
nephrology and pulmonology along with analgesics and central nervous system
drugs for prescribing by office- and hospital-based physicians. 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 more than 5,500 employees
worldwide and a commercial presence in roughly 65 countries. The company’s
fiscal 2013 revenue totaled $2.2 billion. To learn more about Mallinckrodt,
visit www.mallinckrodt.com.

FORWARD-LOOKING STATEMENTS

Statements in this document that are not strictly historical, including
statements regarding the Questcor acquisition, 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 Mallinckrodtand Questcor operate; the
commercial success ofMallinckrodt’sand Questcor’s products, including H.P.
Acthar® Gel (“Acthar”);Mallinckrodt’sand Questcor’s ability to protect
intellectual property rights;Mallinckrodt’sability to successfully integrate
Questcor’s operations and employees withMallinckrodt’sexisting 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 possibleUnited 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 ofMedicaid-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 obtainFDAapproval of Synacthen™
Depot;Mallinckrodt’s ability to receive procurement and production quotas
granted by theU.S. Drug Enforcement Administration;Mallinckrodt’sability 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’sability to successfully develop or commercialize
new products; competition;Mallinckrodt’sability to achieve anticipated
benefits of price increases;Mallinckrodt’sability 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’sSECfilings,
including its Annual Report on Form 10-K for the fiscal year endedSeptember
27, 2013 and its Quarterly Reports on Form 10-Q for the quarterly periods
endedDecember 27, 2013,March 28, 2014 and June 27, 2014; (ii)
theSECfilings ofCadence Pharmaceuticals, Inc., which was acquired
byMallinckrodtonMarch 19, 2014, including its Annual Report on Form 10-K
for the fiscal year endedDecember 31, 2013; and (iii) Questcor’sSECfilings,
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 Reports on Form
10-Q for the quarterly periods endedMarch 31, 2014andJune 30, 2014, and its
Current Report on Form 8-K filed with theSEConJuly 10, 2014. The
forward-looking statements made herein speak only as of the date hereof and
none ofMallinckrodt, 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.

Contact:

Mallinckrodt
Lynn Phillips, 314-654-3263
Manager, Media Relations
lynn.phillips@mallinckrodt.com
or
Meredith Fischer, 314-654-6595
Senior Vice President, Communications
meredith.fischer@mallinckrodt.com
or
John Moten, 314-654-6650
Vice President, Investor Relations
john.moten@mallinckrodt.com
 
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