MISSISSAUGA, ON, Nov. 3, 2014 /PRNewswire/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced that
it plans to commence a Phase 3 clinical study of Pennsaid 2% for
the treatment of acute pain to support regulatory approval
applications for Pennsaid 2% in international jurisdictions.
The study will be conducted in Germany to assess the efficacy of Pennsaid 2%
for the relief of pain associated with acute, localized muscle or
joint injuries such as sprains, strains or sports injuries.
Commencement of the study, which is subject to German regulatory
approval, is expected in Q2 2015 with top-line results expected Q4
2015. The study will cost approximately CDN$1.5 million.
"This Phase 3 study will support regulatory approval in many
jurisdictions, including the European Union and is an integral part
of our plan to seek a partner or partners to market Pennsaid 2%
internationally and make Pennsaid 2% a global brand," said
Dan Chicoine, Nuvo's Chairman and
Co-CEO. "While the global topical NSAID market is
competitive, we believe that Pennsaid 2%'s superior product
attributes make it a very desirable asset for potential
licensees."
About the Phase 3 Clinical Study of Pennsaid 2%
The
Phase 3 study will be a randomized, double-blind,
placebo-controlled study evaluating the efficacy and safety of
Pennsaid 2% for the relief of pain associated with recent (acute),
localized muscle or joint injuries such as sprains, strains or
sports injuries (for example ankle sprain). The primary
endpoint will be change in pain on movement (POM) from day 1 to day
5. It will also measure other secondary endpoints.
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
osteoarthritis (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 6 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 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 has four U.S. Food and Drug
Administration (FDA) approved commercial products, a pipeline of
topical and transdermal products focusing on pain and dermatology
and four 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, a
development program for the treatment of allergic rhinitis and an
immune system modulation platform that has the potential to support
treatments for a broad range of immune system related
disorders. For additional company information visit
www.nuvoresearch.com.
Forward-Looking Statements
Certain statements in
this MD&A constitute forward-looking statements within the
meaning of applicable securities laws. Forward-looking statements
include, but are not limited to the Company's anticipated use of
proceeds from the sale of Pennsaid 2% U.S. rights to Horizon Pharma
plc, the litigation settlement with Mallinckrodt Inc. and from the
March 2014 Private Placement, the
Company's future share price and the Company's possible election to
accelerate the expiry date of any of the warrants or the brokers
warrants 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 20, 2014 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
news 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 news release are qualified by
these cautionary statements. The forward-looking statements
contained herein are made as of the date of this news 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.