MISSISSAUGA, ON, Aug. 11, 2015 /CNW/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced that the United States Patent and Trademark Office has granted a new U.S. patent number 9,084,754 ('754 Patent). The '754 Patent claims cover highly permeating topical formulations of terbinafine, an antifungal drug, and methods for treating onychomycosis. Onychomycosis is a prevalent fungal infection of the nail. The '754 Patent will expire on March 8, 2031. Related patents have been issued in Australia and are pending in Canada, China, Europe, Japan and the United States. Nuvo has pioneered formulations utilizing chemical penetration enhancers in other topically-applied drug products including the Company's lead products, Pennsaid® and Pennsaid 2%.
"Onychomycosis is an uncomfortable and embarrassing condition that affects approximately 10% of the population," said Dan Chicoine, Nuvo's Chairman and Co-CEO. "Existing therapies have side effects or limited efficacy creating a significant market opportunity for a topical product that can safely eradicate the fungal infection. These patents afford Nuvo another avenue to realize value from our investments and scientific accomplishments in delivering drugs into or through skin and nails. Our strategy is to make this formulation available for out-licensing collaborations with partners who will fund completion of the development program."
Onychomycosis (also known as dermatophytic onychomycosis or tinea unguium) is a fungal infection of the nail. It is the most common disease of the nails and constitutes about half of all nail abnormalities. This condition may affect toenails or fingernails, but toenail infections are particularly common. It occurs in about 10 percent of the adult population.
Pennsaid is used to treat the signs and symptoms of osteoarthritis (OA) of the knee(s). The drug combines a transdermal carrier (containing DMSO) with 1.5% diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) and delivers the active drug through the skin directly to the site of inflammation and pain. Following FDA approval of Pennsaid 2%, Pennsaid is no longer marketed in the U.S. effective January 1, 2015. It is currently marketed in Canada by Paladin Labs Inc. and marketed under license and/or distribution agreements in Greece, Italy and the U.K.
About Pennsaid 2%
Pennsaid 2% is a topical product containing 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is approved in the U.S. for pain of OA of the knee(s). It is more viscous than Pennsaid, is supplied in a metered dose pump bottle and has been approved in the U.S. for twice daily dosing compared to four times a day for Pennsaid. Pennsaid 2% is protected by multiple U.S. patents that are listed in the U.S. Food and Drug Administration's (FDA's) Approved Drug Products with Therapeutic Equivalence Evaluations database or Orange Book. Pennsaid 2% has not yet received regulatory approval outside of the U.S. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company with a diverse portfolio of products and technologies. The Company operates two distinct business units: the Topical Products and Technology (TPT) Group and the Immunology Group. The TPT Group currently has four commercial products, a pipeline of topical and transdermal products focusing on pain and dermatology and multiple drug delivery platforms that support the development of patented formulations that can deliver actives into or through the skin. The Immunology Group has two commercial products and an immune system modulation platform that supports the development of drug products that modulate chronic inflammation processes resulting in a therapeutic benefit. For additional company information visit www.nuvoresearch.com.
Certain statements in this press 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 general business and economic uncertainties and adverse market conditions as well as other risk factors included in the Company's Annual Information Form dated February 19, 2015 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 press 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. All forward-looking statements in this press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press 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.
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