MISSISSAUGA, ON, Dec. 14, 2017 /CNW/ - Nuvo Pharmaceuticals Inc.
(Nuvo or the Company) (TSX: NRI; OTCQX: NRIFF), a commercial
healthcare company with a portfolio of commercial products and
pharmaceutical manufacturing capabilities, today announced it has
entered into a license and distribution agreement (License
Agreement) with Gebro Pharma AG (Gebro Pharma) for the exclusive
right to register, distribute, market and sell Pennsaid®
2% in Switzerland and Liechtenstein (the Territory). Gebro
Pharma AG is the Switzerland-based
affiliate of Gebro Holding GmbH, an Austrian-based pharmaceutical
company with a commercial presence via subsidiaries and partners in
over 25 countries globally.
"We are extremely pleased to partner Pennsaid 2% with Gebro
Pharma in Switzerland and
Liechtenstein," said Jesse Ledger, Nuvo's President & CEO.
"Gebro Pharma's strong presence in rheumatology, pain and
over-the-counter brands make it an ideal partner for Nuvo in this
region. This transaction is an example of our ongoing
progress towards making Pennsaid 2% a global brand."
Marcel Plattner, CEO, Gebro
Pharma said, "Our collaboration with Nuvo allows us to bring a
novel, best-in-class treatment for osteoarthritis to patients in
Switzerland and
Liechtenstein. Pennsaid 2% adds an additional first-line
treatment option to our growing portfolio of pain and rheumatology
medicines."
License Agreement Details
The License Agreement grants
Gebro Pharma the exclusive rights throughout the Territory to
register, market, sell and distribute Pennsaid 2% as a
non-prescription drug for the human treatment of osteoarthritis of
the knee and acute pain from sprains and strains. Nuvo will
provide Gebro Pharma with its existing Pennsaid 2% regulatory
dossier and the U.S. Food and Drug Administration (FDA) approval of
Pennsaid 2%, which Gebro Pharma will use to support its application
for regulatory approvals in Switzerland and Liechtenstein. Nuvo is eligible to
receive milestone payments and royalties on net sales of Pennsaid
2% in the Territory and will earn product revenue from Gebro Pharma
pursuant to an exclusive supply agreement. Pennsaid 2% is
manufactured at the Company's facility in Varennes, Québec.
About Pennsaid 2%
Pennsaid 2% is a 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 Gebro Pharma AG
Gebro Pharma AG is the
Switzerland-based affiliate of
Gebro Holding GmbH, a successful Austrian-based pharmaceutical
company. Gebro Pharma specializes in the commercialization of
innovative pharmaceutical products for both prescription and
over-the-counter use. Gebro Pharma is an excellent partner
for the Swiss market with a strong market presence in rheumatology,
pain and dermatology, as well as for over-the-counter products.
The added-value products and services in Gebro Pharma's
portfolio are designed to enhance our patients' quality of
life.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX: NRI; OTCQX:
NRIFF) 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) 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.
Forward-Looking Statements
This Press Release
contains "forward-looking statements" within the meaning of
applicable securities laws. Forward-looking statements can be
identified by words such as: "anticipate," "intend," "plan,"
"goal," "seek," "believe," "project," "estimate," "expect,"
"strategy," "future," "likely," "may," "should," "will" and similar
references to future periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
the Company's current beliefs, expectations and assumptions
regarding the future of its business, future plans and strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of the Company's control. Nuvo's actual results
and financial condition may differ materially from those indicated
in the forward-looking statements. Therefore, readers should not
rely on any of these forward-looking statements. Important factors
that could cause Nuvo's actual results and financial condition to
differ materially from those indicated in the forward-looking
statements include, among others, the risk factors included in
Nuvo's most recent 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 Nuvo with Canadian securities regulatory
agencies and commissions. These and other factors should be
considered carefully and readers should not place undue reliance on
Nuvo'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 none of Nuvo or any
other person assumes responsibility for the accuracy and
completeness of these forward-looking statements.
Any forward-looking statement made by the Company in this
Press Release is based only on information currently available to
it and speaks only as of the date on which it is made. Except as
required by applicable securities laws, Nuvo undertakes no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
SOURCE Nuvo Pharmaceuticals Inc.