Nuvo Research® Announces U.S. Patent for Topical Foamed Formulations that Include DMSO

MISSISSAUGA, ON, Aug. 20, 2015 /PRNewswire/ - 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 Office has granted U.S. patent no. 9,107,823 ('823 Patent) covering novel topical foam formulations that include dimethyl sulfoxide (DMSO) together with certain drug actives.  Nuvo has pioneered the use of DMSO as a carrier in topically-applied drug products which is a key component of the Company's U.S. Food and Drug Administration (FDA) approved products, Pennsaid^® and Pennsaid 2%. 

The claims of the '823 Patent protect foamable formulations comprising: (i) DMSO in a specified range; (ii) a pharmaceutically active agent that is an anti-inflammatory steroid, a non-steroidal anti-inflammatory drug (NSAID) or a local anesthetic; and (iii) other specified ingredients.  In particular, the patent covers Nuvo's novel IBUFOAM drug candidate that contains DMSO and the NSAID Ibuprofen.  The anticipated expiry date of the patent is November 22, 2031.  

"This patent provides broad intellectual property protection for foam formulations that use DMSO to enhance delivery of specified categories of known active drugs into or through the skin," said Tina Loucaides, Nuvo's Vice-President, Secretary and General Counsel.  "The patent affords Nuvo another avenue to realize value from our investments and scientific accomplishments in topical and transdermal drug delivery.  Our strategy is to make this patented dosage form platform, including IBUFOAM, available for development and out-licensing collaborations with partners who will fund completion of the development program."

About IBUFOAM
IBUFOAM has been developed to treat acute and chronic pain conditions such as sprains and strains and osteoarthritis (OA).  IBUFOAM is a topical ibuprofen foam formulation that combines a transdermal carrier DMSO with 5% the NSAID ibuprofen and delivers the active drug through the skin directly to the site of inflammation and pain.  IBUFOAM has not yet been studied in clinical trials or approved by regulatory authorities for sale and is available for out-licensing to partners that would complete its development.  Significant chemistry, manufacturing and controls (CMC) information, including stability data, as well as non-clinical data are available to support an Investigational New Drug (IND) submission.

About Pennsaid
Pennsaid is used to treat the signs and symptoms of OA of the knee(s).  The drug combines a transdermal carrier (containing 45.5% w/w DMSO) with 1.5% diclofenac sodium, an 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 DMSO and 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) and, like Pennsaid, contains 45.5% w/w DMSO.  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 dosing for Pennsaid.  Pennsaid 2% is protected by multiple U.S. patents that are listed in the 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 DMSO
Dimethyl sulfoxide (DMSO) is an organosulfur compound with the formula (CH₃)₂SO.  This colourless liquid is an important polar aprotic solvent that dissolves both polar and nonpolar compounds and is miscible in a wide range of organic solvents as well as water.  DMSO has the proven ability to enhance penetration of certain active drug ingredients into or through the skin. The pharmaceutical grade of DMSO utilized by the Company in Pennsaid, Pennsaid 2% and IBUFOAM is listed in the FDA's Inactive Ingredient Database under the topical route of administration.

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.

Forward-Looking Statements
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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