MISSISSAUGA, ON, Sept. 5, 2012 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain today announced that the United States Patent Office has issued United States Patent # 8,252,838 relating to compositions and methods of using PENNSAID® (diclofenac sodium topical solution) 2.0% w/w (PENNSAID 2% Patent). The patent expires on April 21, 2028.
Nuvo's U.S. licensing partner, Mallinckrodt Inc. (Mallinckrodt), the pharmaceuticals business of Covidien, has advised Nuvo that the U.S. Food and Drug Administration (FDA) had accepted a New Drug Application (NDA) for PENNSAID (diclofenac sodium topical solution) 2.0% w/w for review and set a Prescription Drug User Fee Act (PDUFA) date of March 4, 2013 for action on the submission. Mallinckrodt will take the necessary steps to have the new patent listed in the FDA Orange Book upon FDA approval.
"We are very pleased that we have been able to secure additional patent protection for PENNSAID 2%," said Tina Loucaides, Nuvo's Vice President and General Counsel. "This patent, together with our recently announced method of use patent for PENNSAID and PENNSAID 2% gives us a strong patent portfolio that will support the PENNSAID franchise."
About PENNSAID 2%
PENNSAID 2% is the follow-on product to original PENNSAID, a topical non-steroidal anti-inflammatory drug (NSAID). PENNSAID 2%, which is not approved by the FDA, contains 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 is designed to be applied twice each day compared to four times a day for original PENNSAID. If approved by the FDA, PENNSAID 2%, like PENNSAID, will be indicated for the treatment of the signs and symptoms of osteoarthritis (OA) of the knee.
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 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 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. 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 anaesthesia 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.
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
PENNSAID is 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.
For additional important risk information, including boxed warning, see Full Prescribing Information.
PENNSAID is a registered trademark of Nuvo Research Inc.
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.