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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

ST. LOUIS--(BUSINESS WIRE)--Aug. 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.

Source: Mallinckrodt

Mallinckrodt
Lynn Phillips, 314-654-3263
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