MISSISSAUGA, ON, Aug. 11, 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 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."
About Onychomycosis
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.
About Pennsaid
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.
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.