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Nuvo Research Inc. (NRI.TO) Announces FDA Response to PENNSAID® 2% NDA



3/5/2013 9:59:44 AM

MISSISSAUGA, ON, March 5, 2013 /PRNewswire/ - Nuvo Research Inc. (Nuvo) (TSX:NRI) announced today that its U.S. licensing partner, Mallinckrodt, the Pharmaceuticals Business of Covidien (NYSE:COV), has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following the review of Mallinckrodt's New Drug Application (NDA) for diclofenac sodium topical solution, 2% w/w (PENNSAID 2%).

In the letter, the FDA requires that Mallinckrodt successfully complete a pharmacokinetic study comparing PENNSAID 2% to original PENNSAID 1.5%. Similar pharmacokinetic studies submitted by Mallinckrodt with the NDA were not acceptable to the FDA because reserve samples were not retained at the clinical site. Pharmacokinetic studies are standard studies conducted during a drug development program to identify the total exposure or the amount of drug that reaches the blood stream after a patient receives both single and multiple doses of the product. Mallinckrodt has indicated to Nuvo that it expects to complete the study and submit the results to the FDA in the third calendar quarter of 2013, and that it anticipates the FDA will provide a formal response to the filing within 6 months thereafter.

"While we are disappointed that PENNSAID 2% will not be approved in this review cycle, we are pleased that the FDA has outlined a clear pathway to approval that we believe can be completed in a relatively short time frame," said Dr. Bradley Galer, President of Nuvo's Pain Group. "Upon approval, PENNSAID 2% will be the first and only topical NSAID in the U.S. featuring twice per day dosing and a metered dose pump bottle."

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 nonsteroidal 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 PENNSAID

PENNSAID is a nonsteroidal 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 topical nonsteroidal 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 Research 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 and by in-licensing and acquisition. The Company's product portfolio includes PENNSAID, Pliaglis® and Synera®. PENNSAID, a topical nonsteroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). PENNSAID is sold in the United States by Mallinckrodt Inc., the Pharmaceuticals Business of Covidien, 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 specialty pharmaceutical company specialized in dermatology which will be launching Pliaglis in the U.S. and E.U. in the first half of 2013. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, EuroCept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan®) in several European countries. The Company is also developing the compound WF10, for the treatment of immune related diseases.

INDICATION

PENNSAID® is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

IMPORTANT RISK INFORMATION ABOUT PENNSAID®

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 patients.

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.

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

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.

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%).

Do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant 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.

See Full Prescribing Informationfor additional Important Risk Information.

Forward-Looking Statements for Nuvo Research Inc.

This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the Company's Annual Report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2011. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.

SOURCE Nuvo Research Inc.


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