MISSISSAUGA, Ontario,
November 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 http://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.
Investor Relations, Email: ir@nuvoresearch.com