MISSISSAUGA, ON, March 28, 2017 /PRNewswire/ - Nuvo
Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI), a commercial
healthcare company with a portfolio of commercial products and
pharmaceutical manufacturing capabilities, today announced that it
has entered into an exclusive license agreement with Sayre
Therapeutics PVT Ltd. (Sayre Therapeutics) to distribute, market
and sell Pennsaid 2% in India,
Sri Lanka, Bangladesh and Nepal (the Territory). Nuvo has received
an upfront payment and is eligible to receive milestone payments
and a double-digit royalty on net sales. Nuvo will supply
Pennsaid 2% to Sayre on an exclusive basis from its manufacturing
facility in Varennes, Québec.
"We are extremely pleased that our very capable and committed
new partner, Sayre Therapeutics, will represent the Pennsaid 2%
brand in this significant South Asian region," said Jesse Ledger, Nuvo's President. "We expect
to complete Pennsaid 2% out-licensing agreements for other
territories throughout 2017 and 2018. Our strategy is to make
Pennsaid 2% a global brand which will increase and diversify our
revenue streams and increase capacity utilization at our
manufacturing facility."
Shukrit Chimote, CEO, Sayre
Therapeutics said, "Our collaboration with Nuvo helps us
bring a U.S. FDA approved best-in-class solution to South Asia. Pennsaid adds an additional
first-line treatment option to our growing portfolio of
rheumatology medicines. Pennsaid 2% will greatly benefit the
South Asian patient community and improve their quality of
life."
License Agreement Details
The License Agreement grants
Sayre the exclusive right throughout the Territory to market, sell
and distribute Pennsaid 2% as a prescription drug for the human
treatment of osteoarthritis of the knee and acute pain from sprains
and strains. Nuvo will provide Sayre with its existing Pennsaid 2%
regulatory dossier and the U.S. Food and Drug Administration (FDA)
approval of Pennsaid 2% which Sayre will use to support its
application for regulatory approvals in the countries within the
Territory.
About Pennsaid 2%
Pennsaid 2% is topical non-steroidal
anti-inflammatory drug (NSAID) containing 2% diclofenac
sodium. It is approved by the FDA for treating the pain of
osteoarthritis of the knee(s). Pennsaid 2% is a gel
formulation that is supplied in a metered dose pump bottle.
It is the only topical NSAID approved by the FDA for twice daily
dosing. 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.
Patents protecting Pennsaid 2% have been issued or are pending in
multiple major international territories. Pennsaid 2% has not yet
received regulatory approval outside of the U.S. and
Russia.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX:NRI) is a
commercial healthcare company with a portfolio of commercial
products and pharmaceutical manufacturing capabilities. Nuvo
has three commercial products that are available in a number of
countries; Pennsaid 2%, Pennsaid and the heated
lidocaine/tetracaine patch. Pennsaid 2% is sold in the
U.S. by Horizon Pharma plc (NASDAQ:HZNP), is approved for sale, but
has not yet been commercially launched, in Russia and is available for partnering in
certain other territories around the world. Nuvo manufactures
Pennsaid for the global market and Pennsaid 2% for the U.S. market
at its FDA, Health Canada and E.U. approved manufacturing facility
in Varennes, Québec. For
additional information, please visit
www.nuvopharmaceuticals.com.
About SAYRE:
M/S Sayre Therapeutics
Private Ltd. is South Asia's only integrated platform for
disease management backed by a unique distribution and
commercialization model for novel and / or differentiated drugs,
companion diagnostics and drug-delivery devices in the
super-specialty areas of Oncology and Immunology/Rheumatology.
Sayre Therapeutics was founded in 2015 backed by leading global
venture capital firms. The Sayre team boasts 25 years of global
executive experience in leading Pharmaceuticals, Medical
Diagnostics & Devices companies. Sayre is creating a
portfolio of differentiated global assets in emerging markets,
including India, Pakistan, Sri
Lanka and Nepal which are
witnessing high growth for pharmaceutical products. Sayre has
a geographically focused strategy, strong financial backing and
established relationships with clinicians and regulatory know-how,
and will be a committed partner to licensors like Nuvo
Pharmaceuticals for their global assets.
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, the
future approval, marketing and sale of Pennsaid 2% in certain
jurisdictions, 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 "may", "will", "expect",
"intend", "believe", "should" or "plans", 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, but
are not limited to, general business and economic uncertainties and
adverse market conditions; as well as other risk factors included
in the Company's Management Information Circular dated December 31, 2015 and the Company's Annual
Information Form dated March 1, 2017
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. 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. 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 Pharmaceuticals Inc.