- Top line results expected in Q1 2016
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MISSISSAUGA, ON, Dec. 3, 2015 /CNW/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with growing revenues
and a diverse portfolio of topical and immunology products, today
provided an update on its ongoing Phase 3 clinical trial (the
Trial) of Pennsaid 2% for the treatment of patients who have
suffered an acute ankle sprain.
Trial Status
The Trial, which is being conducted in
Germany, commenced in July of this
year. As of November 25, 2015,
96 patients have been enrolled. The Company is targeting a
total enrollment of 124 patients. The Company expects the
Trial to be completed and top line results available in Q1
2016.
Clinical Regulatory Requirements for International Marketing
Approvals
The Trial is being conducted to support
regulatory applications for marketing approval of Pennsaid 2% for
the treatment of acute pain in the E.U., Canada and Australia. The Company believes that
most other jurisdictions will base their marketing approval on the
current U.S. Food and Drug Administration (FDA) approval of
Pennsaid 2% for the treatment of the pain of osteoarthritis (OA) of
the knee and will not require additional clinical efficacy data.
Some jurisdictions, most notably Russia, China
and Japan, will require local
trials.
Progress on Out-licensing Discussions
The Company has
engaged in preliminary discussions with a number of potential
international licensing partners that have expressed an interest in
licensing the marketing rights for Pennsaid 2% in jurisdictions in
which they operate. PricewaterhouseCoopers Corporate Finance
Inc. (PwC) is assisting the Company in identifying, contacting and
qualifying potential licensees for available territories using its
international offices and contacts. The Company expects to
complete some out-licensing transactions in 2016 with initial
commercial launches commencing in 2017.
Available Territories
Pennsaid 2% was approved by the
FDA on January 16, 2014. In
October 2014, the Company sold the
U.S. rights to Pennsaid 2% to Horizon Pharma plc (Horizon) for
US$45.0 million. The Company
has already licensed Pennsaid 2% marketing rights to Paladin Labs
Inc. for Canada, to NovaMedica LLC
(NovaMedica) for Russia and some
of the Community of Independent States (CIS) and to Vianex S.A. for
Greece, although it has not yet
been approved for marketing in those territories. The Company
recently announced that NovaMedica, Nuvo's licensee for Pennsaid
2%, in Russia and some of the CIS
has advised the Company that it successfully completed a Phase 3
clinical trial of Pennsaid 2% in Russia and that it plans to submit to the
Russian regulatory authorities in support of an application for
Russian marketing approval. Pennsaid 2% is available for
out-licensing in all other territories. An information sheet
outlining the licensing opportunity has been posted to the
Company's website at www.nuvoresearch.com.
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 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 PwC Canada
PwC Canada helps organizations and
individuals create the value they're looking for. More than 5,800
partners and staff in offices across the country are committed to
delivering quality in assurance, tax, consulting and deals
services. PwC Canada is a member of the PwC network of firms with
more than 195,000 people in 157 countries. Find out more by
visiting www.pwc.com/ca.
© 2015 PricewaterhouseCoopers LLP, an Ontario limited liability partnership.
All rights reserved. PwC refers to the Canadian member
firm, and may sometimes refer to the PwC network. Each member
firm is a separate legal entity. Please see
www.pwc.com/structure for further details.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a
specialty pharmaceutical company with a diverse portfolio of
products and technologies. On September 15,
2015, Nuvo announced that it plans to split Nuvo into two
separate, publicly traded companies. One company, to be
known as Nuvo Pharmaceuticals Inc. (Nuvo Pharma), would be a
pure-play commercial healthcare company that would own the
Company's Pennsaid and Pennsaid 2% franchises and related assets
and have positive revenue and EBITDA. The other company, to
be known as Crescita Therapeutics Inc. (Crescita), would be a
pure-play biotech development company that would own the Company's
existing drug development business including its pipeline of
product candidates. The companies would be distinct and
separately traded public companies. Nuvo shareholders would
receive shares of both companies. Complete details of the
proposed transaction will be set forth in an information circular
that will be mailed to Nuvo's shareholders in Q1 2016 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 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. 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, potential regulatory approval for Pennsaid 2%
in Russia, and other statements
concerning the Company's future objectives, strategies to achieve
those objectives, as well as 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.