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Mallinckrodt Pharmaceuticals’ New Drug Application Accepted for Review by FDA



  Mallinckrodt Pharmaceuticals’ New Drug Application Accepted for Review by
  FDA

 Mallinckrodt’s MNK-395 – diclofenac sodium topical solution 2% w/w accepted
               for filing by U.S. Food and Drug Administration

Business Wire

ST. LOUIS -- August 22, 2013

Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for filing the New Drug Application (NDA)
for MNK-395. MNK-395 is referred to in the application as PENNSAID^®
(diclofenac sodium topical solution) 2% w/w, studied in the treatment of the
pain of osteoarthritis of the knee.

The NDA was resubmitted by Mallinckrodt on August 7, 2013, in answer to a
Complete Response Letter from the FDA that included the request for an
additional pharmacokinetic study.

“We have a diverse portfolio focused on pain management, and are committed to
providing options for patients who suffer from osteoarthritis of the knee,”
said Mark Trudeau, Chief Executive Officer and President, Mallinckrodt. “We
are pleased that the FDA accepted the application for filing. If approved,
this product will be an important addition to the Mallinckrodt Pharmaceuticals
product line.”

Mallinckrodt continues to market PENNSAID (diclofenac sodium topical solution)
1.5% w/w, a nonsteroidal anti-inflammatory drug (NSAID) used for the treatment
of the signs and symptoms of osteoarthritis of the knee. Under the terms of a
U.S. Licensing and Development Agreement with Nuvo Research signed in June
2009, Mallinckrodt is responsible for managing development activities for
PENNSAID 2%.

PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w

INDICATIONS AND USAGE

PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w is a nonsteroidal
anti-inflammatory drug (NSAID) indicated for the treatment of signs and
symptoms of osteoarthritis of the knee(s).

IMPORTANT RISK INFORMATION

 
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
 
Cardiovascular Risk
     Nonsteroidal 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.
      

CONTRAINDICATIONS

  * PENNSAID is also contraindicated in patients:

       * with a known hypersensitivity to diclofenac sodium or any other
         component of PENNSAID
       * who have experienced asthma, urticaria, or allergic-type reactions
         after taking aspirin or other NSAIDs. Severe, rarely fatal
         anaphylactic-like reactions to NSAIDs have been reported in such
         patients

WARNINGS AND PRECAUTIONS

  * Elevation of one or more liver tests may occur during therapy with NSAIDs.
    PENNSAID should be discontinued immediately if abnormal liver tests
    persist or worsen.

  * Use with caution in patients with fluid retention or heart failure.
    Hypertension can occur with NSAID treatment. Monitor blood pressure
    closely with PENNSAID treatment.
  * Long-term administration of NSAIDs can result in renal papillary necrosis
    and other renal injury. Use PENNSAID with caution in patients at greatest
    risk of this reaction, including the elderly, those with impaired renal
    function, heart failure, liver dysfunction, and those taking diuretics and
    ACE-inhibitors.
  * Anaphylactoid reactions may occur in patients without prior exposure to
    PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative
    dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis
    (TEN), which can be fatal.
  * Do not apply to open wounds. Protect treated knee(s) from natural or
    artificial sunlight. Topicals such as sunscreen and bug repellent may be
    applied after PENNSAID treated knee(s) are completely dry. Avoid contact
    of PENNSAID with eyes and mucous membranes. Wash and dry hands after use.
    Concurrent use with oral NSAIDs should be avoided unless benefit outweighs
    risk and periodic laboratory evaluations are conducted.

ADVERSE REACTIONS

  * The most common treatment-related adverse events in patients receiving
    PENNSAID were application site skin reactions including dry skin (32%),
    contact dermatitis characterized by skin erythema and induration (9%),
    contact dermatitis with vesicles (2%) and pruritus (4%). In a long-term
    safety study, contact dermatitis occurred in 13% and contact dermatitis
    with vesicles in 10% of patients, generally within the first 6 months of
    exposure, leading to a withdrawal rate for an application site event of
    14%. Other common adverse events greater than placebo include: dyspepsia
    (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%), and nausea
    (4%).

USE IN SPECIFIC POPULATIONS

  * PENNSAID should not be used in pregnant or lactating women and is not
    approved for use in pediatric patients.

See Full Prescribing Information for additional Important Risk Information.

PENNSAID is a registered trademark of Nuvo Research Inc.

ABOUT MALLINCKRODT:

Mallinckrodt is a leading global specialty pharmaceuticals business that
develops, manufactures, markets, and distributes specialty pharmaceutical
products and medical imaging agents. The Company’s Specialty Pharmaceuticals
segment includes branded and generic drugs, and the Global Medical Imaging
segment includes contrast media and nuclear imaging agents. Mallinckrodt has
approximately 5,500 employees worldwide with a direct sales presence in
roughly 50 countries and distribution in approximately 40 other countries. The
Company’s 2012 revenue totaled $2.1 billion. To learn more about Mallinckrodt,
visit www.mallinckrodt.com.

FORWARD-LOOKING STATEMENTS

Any statements contained in this communication that do not describe historical
facts may constitute forward-looking statements as that term is defined in the
Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include, but are not limited to, statements about future financial
condition and operating results, economic, business, competitive and/or
regulatory factors affecting our business. Any forward-looking statements
contained herein are based on our management's current beliefs and
expectations, but are subject to a number of risks, uncertainties and changes
in circumstances, which may cause actual results or Company actions to differ
materially from what is expressed or implied by these statements. The factors
that could cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to receive
procurement and production quotas granted by the U.S. Drug Enforcement
Administration, our ability to obtain and/or timely transport molybdenum-99 to
our technetium-99m generator production facilities, customer concentration,
cost-containment efforts of customers, purchasing groups, third-party payors
and governmental organizations, our ability to successfully develop or
commercialize new products, our ability to protect intellectual property
rights, competition, our ability to integrate acquisitions of technology,
products and businesses, product liability losses and other litigation
liability, the reimbursement practices of a small number of large public or
private issuers, complex reporting and payment obligation under healthcare
rebate programs, changes in laws and regulations, conducting business
internationally, foreign exchange rates, material health, safety and
environmental liabilities, litigation and violations and information
technology infrastructure. These and other factors are identified and
described in more detail in the “Risk Factors” section of the Form 10
Registration Statement, as amended. We disclaim any obligation to update these
forward-looking statements other than 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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