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.