Mallinckrodt Pharmaceuticals New Drug Application Approved by the FDA

  Mallinckrodt Pharmaceuticals New Drug Application Approved by the FDA

    Mallinckrodt’s PENNSAID^® (diclofenac sodium topical solution) 2% w/w
(PENNSAID 2%) approved for the treatment of the pain of osteoarthritis of the

Business Wire

ST. LOUIS -- January 17, 2014

Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug
Administration (FDA) has approved the New Drug Application (NDA) for
PENNSAID^® (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a
topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the
treatment of the pain of osteoarthritis of the knee(s).

PENNSAID 2% is supplied in an easy to use metered dose pump bottle and is
applied twice each day. PENNSAID 2% delivers an accurate amount (20 mg of
diclofenac per pump actuation) and can be applied directly to the affected

“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 approved the application and believe this product
will be an important addition to the Mallinckrodt Pharmaceuticals product

U.S. sales and marketing rights for PENNSAID 2% are licensed to Mallinckrodt
by Nuvo Research Inc.

PENNSAID^® (diclofenac sodium topical solution) 2% w/w



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.


  *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


  *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
  *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.
  *Wash and dry hands before and after use. Avoid contact of PENNSAID with
    the eyes and mucous membranes
  *PENNSAID was not evaluated under the conditions of heat application,
    occlusive dressings overlay, or exercise; therefore, concurrent use of
    PENNSAID under these conditions is not recommended.
  *Do not:

apply PENNSAID to open wounds.

shower for at least 30 minutes after applying PENNSAID.

wear clothing over the PENNSAID treated knee until the treated knee is dry

  *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.
  *Concurrent use with oral NSAIDs should be avoided unless benefit outweighs
    risk and periodic laboratory evaluations are conducted


  *The most common adverse events in a phase 2 clinical trial of PENNSAID 2%
    were application site reactions, such as dryness (22%), exfoliation (7%),
    erythema (4%), pruritus (2%), pain (2%), induration (2%), rash (2%), and
    scabbing (<1%). Other adverse reactions occurring in >1% of patients
    receiving PENNSAID 2% included urinary tract infection (3%), contusion
    (2%), sinus congestion (2%), and nausea (2%).
  *The most common treatment-related adverse events in patients receiving
    PENNSAID 1.5% 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%).


  *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
including boxed warning.

PENNSAID is a registered trademark of Nuvo Research Inc.


Mallinckrodt is a global specialty pharmaceutical 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 active pharmaceutical ingredients, and
the Global Medical Imaging segment includes contrast media and nuclear imaging
agents. Mallinckrodt has approximately 5,500 employees worldwide and
commercial presence in roughly 70 countries. The company’s fiscal 2013 revenue
totaled $2.2 billion. To learn more about Mallinckrodt, visit


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facts may constitute forward-looking statements as that term is defined in the
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statements include, but are not limited to, statements about future financial
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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,
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and governmental organizations, our ability to successfully develop or
commercialize new products, our ability to protect intellectual property
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environmental liabilities, litigation and violations, information technology
infrastructure and restructuring activities.These and other factors are
identified and described in more detail in the “Risk Factors” section of
Mallinckrodt’s Annual Report on Form 10-K for the fiscal year ended September
27, 2013. We disclaim any obligation to update these forward-looking
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Lynn Phillips, 314-654-3263
Manager, Media Relations
Meredith Fischer, 314-654-3318
Senior Vice President, Communications
John Moten, 314-654-6650
Vice President, Investor Relations
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