Nuvo announces Mallinckrodt submits PK study report in response to PENNSAID® 2% FDA complete response letter

News provided by

Aug 15, 2013, 07:30 ET

MISSISSAUGA, ON, Aug. 15, 2013 /PRNewswire/ - Nuvo Research Inc. (Nuvo) (TSX:NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensing partner for PENNSAID^®(diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt (NYSE:MNK) has submitted the results of a pharmacokinetic (PK) study to the U.S. Food and Drug Administration (FDA) in support of its New Drug Application for PENNSAID 2%.

On March 4, 2013, Mallinckrodt received a Complete Response Letter (CRL) from the FDA following the review of Mallinckrodt's New Drug Application for PENNSAID 2%. In the CRL, the FDA required that Mallinckrodt complete a PK study comparing PENNSAID 2% to original PENNSAID. Mallinckrodt completed the PK study and on August 7, 2013 submitted the clinical study report to the FDA. The FDA is expected to advise Mallinckrodt if the resubmission is acceptable for review within 14 days of the filing and to provide a formal response to Mallinckrodt within 6 months of the filing.

About PENNSAID

PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) used for treating the signs and symptoms of osteoarthritis of the knee(s).

PENNSAID is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC^®), patient overall health assessment (POHA), and patient global assessment of knee osteoarthritis.

PENNSAID is a registered trademark of Nuvo Research Inc.

WOMAC is a registered trademark of Nicholas Bellamy.

WOMAC^® is a proprietary health status questionnaire. For further information visit the WOMAC^® website at www.WOMAC.com.

About PENNSAID 2%

PENNSAID 2% is a follow-on product to original PENNSAID which is currently marketed in the U.S. by Mallinckrodt under license from Nuvo. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium compared to 1.5% for original PENNSAID. It is more viscous than original PENNSAID, is supplied in a metered dose pump bottle and was studied in clinical trials using twice daily dosing compared to four times a day for original PENNSAID.

About Nuvo Research Inc.

Nuvo is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development. The Company's product portfolio includes Pennsaid^®, Pliaglis and a heated lidocaine/tetracaine patch (HLT patch). Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the U.S. by Mallinckrodt Inc. in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global pharmaceutical company specialized in dermatology. Galderma launched the marketing and sale of Pliaglis in the U.S. in March of 2013 and in the E.U. in April of 2013. The HLT patch is a topical patch that combines lidocaine, tetracaine and heat and is approved in the U.S. to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo's licensing partner, Galen US Incorporated markets the HLT patch (under the name Synera) in the U.S. In Europe, Nuvo's licensing partner, Eurocept International B.V., has initiated a pan-European launch of the HLT patch (under the name Rapydan). The Company is also developing WF10, for the treatment of immune related diseases.

Further information on Nuvo Research is available on the company's website www.nuvoresearch.com or by contacting:

Investor Relations Email: [email protected]

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.

Forward-Looking Statements
Certain statements in this news release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements concerning the Company's future objectives, strategies to achieve those objectives, as well as statements with respect to management's beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "outlook", "objective", "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "should", "plans" or "continue", or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include the need for additional financing, the current economic environment, dependence on sales and marketing partnerships, competitive developments, as well as other risk factors included in the Company's annual information form dated March 27, 2013 under the heading "Risks Factors" and as described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. This list is not exhaustive of the factors that may impact the Company's forward-looking statements. These and other factors should be considered carefully and readers should not place undue reliance on the Company's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The factors underlying current expectations are dynamic and subject to change. Although the forward-looking information contained in this news release is based upon what management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. Certain statements included in this news release may be considered "financial outlook" for purposes of applicable securities laws, and such financial outlook may not be appropriate for purposes other than this news release. All forward-looking statements in this news release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this news release and except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE Nuvo Research Inc.