MISSISSAUGA, ON, June 24, 2015 /CNW/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today provided an
update on its international licensing initiatives for Pennsaid
2%.
Regulatory Approval to Conduct Phase 3 Trial
The
Company has received approval from the German Federal Institute for
Drugs and Medical Devices (BfArM) to conduct a placebo controlled
Phase 3 trial of Pennsaid 2% for the treatment of acute ankle
sprains. The 124 patient trial will be conducted in
Germany commencing early July of
this year. Topline results are expected to be available in Q4
2015 or Q1 2016. The trial is intended to support regulatory
applications for marketing approval of Pennsaid 2% in the E.U.,
Canada and certain other
international territories.
PricewaterhouseCoopers retained to Support
Out-licensing
The Company has retained
PricewaterhouseCoopers Corporate Finance Inc. (PwC) to assist it in
securing international license agreements for Pennsaid 2%.
PwC will assist Nuvo in identifying, contacting and qualifying
potential licensees for available territories using its
international offices and contacts. An information sheet
outlining the licensing opportunity has been posted to the
Company's website at www.nuvoresearch.com.
Available Territories
Pennsaid 2% was approved by the
U.S. Food and Drug Administration (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 million. The Company has licensed
Pennsaid 2% marketing rights to Paladin Labs Inc. for Canada, to NovaMedica LLC for Russia and some of the Community of
Independent States and to Vianex S.A. for Greece. Pennsaid 2%
is available for out-licensing in all other territories.
U.S. Market Update
Under the terms of an exclusive
manufacturing agreement, the Company earns revenue from U.S.
product sales of Pennsaid 2% to Horizon. Since its launch by
Horizon on January 1, 2015, U.S.
prescriptions for Pennsaid 2% have increased more than fivefold
compared to the number of prescriptions being generated by Nuvo's
previous U.S. licensee.
"Horizon's successful launch of Pennsaid 2% in the U.S. supports
our belief that Pennsaid 2% is one of the most effective and
patient-friendly topical NSAIDs available anywhere in the world and
has the potential to become a major global brand," said
Dan Chicoine, Nuvo's Chairman and
Co-CEO. "PwC's understanding of the international
pharmaceutical business and its vast network of international
connections will help us secure profitable commercial terms from
the most qualified licensees."
Any inquiries and requests for information related to the
international licensing of Pennsaid 2% should be addressed to
Nitin Kaushal at (416) 687-8269 or
nitin.kaushal@ca.pwc.com or Shilpa
Joshi at (416) 869-2482 or shilpa.joshi@ca.pwc.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
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 7 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. 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.