- Plans to spin-off WF10™ and focus on
generating additional revenues -
MISSISSAUGA, ON, April 16, 2015 /PRNewswire/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced a
revised strategy for the Company.
The Company has examined strategic alternatives with a view to
increasing shareholder value by obtaining better recognition of:
(a) the Company's revenue generating assets, which include
Pennsaid® 2%, Pennsaid, Pliaglis, Oxoferin™ and the
heated lidocaine/tetracaine (HLT) Patch, (b) its cash position,
which as of December 31, 2014 was
$58.3 million, and (c) the potential
of WF10 as a treatment for allergic rhinitis.
After examining alternative structures and transactions
internally, and with the assistance of outside consultants, the
Company has determined that it should work towards spinning out
WF10-related assets into a separate research and development
(R&D) focused entity and transition Nuvo from a biotech company
concentrated mainly on drug development into a more diversified,
profitable, cash flow positive business. To achieve this
objective, the Company plans to:
- Seek to acquire new products or businesses with a focus on
those that can become accretive to Nuvo's profitability and cash
flow. A process to identify and review opportunities has been
commenced with the assistance of the Toronto-based, healthcare specialized
investment bank, Bloom Burton & Co.;
- Maximize the value of the Pennsaid 2% franchise by out
licensing its rights for available international territories;
and
- Curtail R&D expenses. Beyond 2015, R&D
expenditures will be reduced and limited chiefly to projects for
which partners fund clinical trial costs. The major clinical
programs funded by the Company planned for 2015 are:
- A new Phase 2 trial of WF10 for the treatment of allergic
rhinitis (the 2015 WF10 Trial) whose design has been developed
based on insights gained from the WF10 Phase 2 study whose results
were announced in January 2015.
If the 2015 WF10 Trial is successful, the Company plans to
continue WF10 development in an independently financed entity that
will include the participation of Nuvo shareholders. While
Nuvo's management is optimistic that the 2015 WF10 Trial will be
successful, in the event that the new study is unsuccessful the
Company will discontinue WF10 development. Results of the
trial are expected before the end of 2015. Details of the
2015 WF10 Trial will be announced in the coming days; and
- A Phase 3 clinical trial in Germany of Pennsaid 2% for the treatment of
acute pain that will support regulatory approval applications for
and out licensing of Pennsaid 2% in international
jurisdictions. Commencement of the Pennsaid 2% trial, which
is subject to German regulatory approval, is expected in Q2 2015
with topline results anticipated in Q4 2015. The estimated
cost of the trial is CDN$1.5
million.
"We believe that execution of our strategy to spinout a new
company focused on WF10 development, coupled with the pursuit of
strategic transactions that build on Nuvo's base of revenue
generating products will build shareholder value," said
Dan Chicoine, Nuvo's Chairman and
Co-CEO. "While we will consider all transaction
opportunities, we are giving priority to those that can add to
existing revenue streams and move Nuvo toward profitability."
The Company will provide updates as material elements described
in the strategy are achieved.
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 WF10
WF10 is a solution containing stabilized
chlorite ions that focuses on supporting the immune system by
targeting the macrophage, a type of white blood cell that
coordinates much of the immune system, to regulate normal immune
function. WF10 is an infusion therapy currently approved only
in Thailand under the name
IMMUNOKINE for the treatment of post-radiation-therapy syndromes
and adjunctive therapy of diabetic foot ulcers.
About Bloom Burton & Co.
Bloom Burton & Co. is
a firm dedicated to accelerating returns in healthcare for both
investors and companies. Bloom Burton has an experienced team of
medical, scientific, pharmaceutical, legal and capital markets
professionals who perform a deep level of diligence, which combined
with a creative and entrepreneurial approach, assists our clients
in achieving the right monetization events. Bloom Burton and
its affiliates provide capital raising, M&A advisory, equity
research, business strategy and scientific consulting, direct
investing and company creation and incubation services. Bloom
Burton & Co. Limited is a member of the Investment Industry
Regulatory Organization of Canada
(IIROC) and is also a member of the Canadian Investor Protection
Fund (CIPF). Please visit www.bloomburton.com to learn
more.
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, 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 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.