MISSISSAUGA, ON, Nov. 5, 2015 /CNW/ - Nuvo Research Inc. (TSX:NRI)
(Nuvo or the Company), a specialty pharmaceutical company with
growing revenues and a diverse portfolio of topical and immunology
products, today announced the successful completion of a Pennsaid
2% Phase 3 clinical trial sponsored by NovaMedica LLC (NovaMedica),
Nuvo's licensee for Pennsaid 2% in Russia and some of the Community of
Independent States. NovaMedica has advised that the 7-week
Russian study of 95 patients with osteoarthritis (OA) of the knee
met its required endpoints and that NovaMedica intends to file for
regulatory approval of Pennsaid 2% in Russia.
"This is an important step forward for Nuvo as we execute our
plan to maximize global Pennsaid 2% revenues through out-licensing
agreements with strong commercial partners like NovaMedica," said
John London, Nuvo's President and
Co-CEO. "It also supports our previously announced strategy
of spinning out our biotech drug development business into a
separate public company owned by Nuvo shareholders. This will
result in Nuvo, which will retain the Pennsaid and Pennsaid 2%
franchises, becoming a profitable pure-play commercial health care
company with growing revenue."
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
original 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 original 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, including a granted
patent in Russia that expires in
2027.
About NovaMedica
NovaMedica is a Russian
pharmaceutical company established in 2012 by DRI Holdings Limited,
a portfolio company of Domain Associates LLC, and Russian
investment corporation RUSNANO, which implements government policy
on the development of hi-tech industries. NovaMedica's
strategy is aimed at localizing production of a wide range of new
medicines and technologies in the Russian market, including
screening and registration, and the creation of innovative
GMP-standard manufacturing facilities. www.novamedica.com.
About Nuvo's Plans to Split Nuvo into Two Separate Public
Companies
On September 15,
2015, Nuvo announced that it plans to split Nuvo into two
separate, publicly traded companies. The strategy is intended
to enhance long-term value for Nuvo shareholders. One company
will be a pure-play commercial healthcare company with growing
revenue, significant EBITDA and significant EBITDA growth
potential. The other company will be a pure-play biotech
development company with a deep pipeline of product candidates.
The companies will be distinct and separately traded public
companies. Nuvo shareholders will receive shares of both
companies. Nuvo's cash balance will put both companies in a
strong position for growth. Complete details of the proposed
transaction and each company will be set forth in an information
circular that will be mailed to Nuvo's shareholders in connection
with a special meeting that will be called by Nuvo to approve the
proposed transaction. Completion of the proposed transaction
is subject to certain conditions, including final approval by the
Nuvo Board of Directors, confirmation of the potential tax-free
nature of the transaction for Canadian and U.S. shareholders,
regulatory approval requirements and the approval of Nuvo's
shareholders. If approved by shareholders, Nuvo expects the
proposed transaction would be completed in Q1 2016 (subject to the
satisfaction of all conditions). However, there can be no
assurances regarding the ultimate timing of the proposed
transaction or that the proposed transaction will be completed.
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 information and/or
forward-looking statements (collectively, forward-looking
statements") within the meaning of applicable securities
laws. Forward-looking statements include, but are not limited
to, statements concerning the potential spin-off of Nuvo's drug
development business, the benefits of the spin-off to Nuvo's
shareholders and to each company, the taxable nature of the
spin-off, the expected financial results and condition of each
company, each company's future objectives and strategies to achieve
those objectives, the future prospects of each company as an
independent company, 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", "potentially" 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, uncertainties that may
delay or negatively impact the spin-off or cause the spin-off to
not occur; uncertainties related to each company's ability to
realize the anticipated benefits of the spin-off, including new
focus and anticipated growth; disruptions to operations as a result
of effecting the spin-off; risks and uncertainties related to
obtaining approvals, rulings and consents, or satisfying other
requirements, necessary or desirable to permit or facilitate
completion of the spinoff future factors that may arise making it
inadvisable to proceed with, or advisable to delay, all or part of
the spin-off, the impact of the spinoff on the trading prices for,
and market for trading in, the shares of each company, 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.