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."
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.
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.
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.
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SOURCE Nuvo Research Inc.