- First European Partnering Deal for
Suvexx -
- Up to EUR 1.7
million in upfront and milestone payments
-
MISSISSAUGA, ON, Dec. 21, 2020 /CNW/ - Nuvo Pharmaceuticals Inc.
(TSX: NRI) (OTCQX: NRIFF) d/b/a Miravo Healthcare (Miravo or the
Company), a Canadian focused healthcare company with global reach
and a diversified portfolio of commercial products, today announced
that its wholly owned subsidiary, Nuvo Pharmaceuticals
(Ireland) DAC trading as Miravo
Healthcare (Miravo Ireland), has entered into an exclusive license
and supply agreement (the License Agreement) with Orion Corporation
(Orion) for the exclusive right to package, distribute, market and
sell Suvexx in Finland,
Sweden, Denmark, Norway, Poland, Hungary, Latvia, Lithuania and Estonia (the Territory).
Orion is headquartered in Espoo, Finland with its products marketed in over one
hundred countries worldwide. In FY2019, Orion generated over
EUR 1 billion in net sales.
Orion maintains its own commercial infrastructure in most key
European markets with a focus on neurology, oncology, respiratory
and critical care therapeutics. Orion is a public company
trading on the Nasdaq Helsinki exchange under the HEL:ORNBV and
HEL:ORNAV ticker symbols.
The commercial launch of Suvexx in the Territory is anticipated
to commence in 2022, subject to regulatory approval. The
prescription acute migraine treatment market in the Territory was
valued at over EUR 50 million in the
past 12 months based on Company estimates.
"Our agreement with Orion further demonstrates Miravo's focus on
expanding the footprint of our proprietary products through global
out-licensing transactions," said Jesse
Ledger, Miravo's President & CEO. "Orion's strong
presence and expertise in launching and commercializing innovative
neurology products in Europe makes
them an ideal partner for Suvexx."
License Agreement Details
The License Agreement grants Orion the exclusive rights to
package, market, sell and distribute Suvexx in the Territory.
Orion will be responsible for obtaining and maintaining the
marketing authorizations for Suvexx in the Territory and will also
manage all Territory specific commercial activities. Miravo
Ireland will receive up to EUR 1.7
million in upfront consideration, regulatory and sales-based
milestone payments, as well as royalties on net sales of Suvexx in
the Territory and revenue pursuant to the supply of product.
Suvexx is currently manufactured by the Company's contract
manufacturing partner in the United
States.
About Suvexx
Suvexx is a patent protected, fixed dose combination of naproxen
sodium and sumatriptan that was originally developed by the Aralez
Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. (POZEN) in
collaboration with Glaxo Group Limited, d/b/a GSK (GSK). The
product is formulated with POZEN's patented technology (now owned
by Miravo) of combining a triptan, sumatriptan 85 mg, with an
NSAID, naproxen sodium 500 mg and GSK's RT Technology in a single
tablet. In 2008, the U.S. Food and Drug Administration (FDA)
approved Treximet (the U.S. brand name for Suvexx) for the acute
treatment of migraine attacks, with or without aura, in
adults. Treximet is currently commercialized in the U.S. by
Currax Holdings USA LLC.
Miravo owns the product and intellectual property rights to Suvexx
in Canada and Miravo Ireland owns
the intellectual property rights to Suvexx outside of Canada.
About Orion Corporation
Orion is a globally operating Finnish pharmaceutical company – a
builder of well-being. Orion develops, manufactures and markets
human and veterinary pharmaceuticals and active pharmaceutical
ingredients. The company is continuously developing new drugs and
treatment methods. The core therapy areas of Orion's pharmaceutical
R&D are neurological disorders, oncology, Finnish
heritage rare diseases and respiratory diseases for which Orion
develops inhaled pulmonary medication
under Easyhaler® device portfolio. Orion's net sales
in 2019 amounted to EUR 1,051 million
and the company had about 3,300 employees at the end of the year.
Orion's A and B shares are listed on Nasdaq
Helsinki.
About Miravo Healthcare
Miravo is a Canadian focused, healthcare company with global
reach and a diversified portfolio of commercial products. The
Company targets several therapeutic areas, including pain, allergy,
and dermatology. The Company's strategy is to in-license and
acquire growth-oriented, complementary products for Canadian and
international markets. Miravo's head office is located in
Mississauga, Ontario, Canada, the
international operations are located in Dublin, Ireland and the Company's
manufacturing facility is located in Varennes, Québec, Canada. The
Varennes facility operates in a
Good Manufacturing Practices (GMP) environment respecting the U.S,
Canada and E.U. GMP regulations
and is regularly inspected by Health Canada and the U.S. Food and
Drug Administration. For additional information, please visit
www.miravohealthcare.com.
Forward-Looking Statements
This press release
contains "forward-looking information" as defined under Canadian
securities laws (collectively, "forward-looking statements"). The
words "plans", "expects", "does not expect", "goals", "seek",
"strategy", "future", "estimates", "intends", "anticipates", "does
not anticipate", "projected", "believes" or variations of such
words and phrases or statements to the effect that certain actions,
events or results "may", "will", "could", "would", "should",
"might", "likely", "occur", "be achieved" or "continue" and similar
expressions identify forward-looking statements. In addition, any
statements that refer to expectations, intentions, projections or
other characterizations of future events or circumstances contain
forward-looking statements.
Forward-looking statements are not historical facts but
instead represent management's expectations, estimates and
projections regarding future events or circumstances, including the
anticipated receipt of certain milestone and royalty payments, the
anticipated launch of certain products and the potential impact of
COVID-19. Such forward-looking statements are qualified in their
entirety by the inherent risks, uncertainties and changes in
circumstances surrounding future expectations which are difficult
to predict and many of which are beyond the control of the Company.
Forward-looking statements are necessarily based on a number of
estimates and assumptions that, while considered reasonable by
management of the Company as of the date of this press release, are
inherently subject to significant business, economic and
competitive uncertainties and contingencies and may prove to be
incorrect. Material factors and assumptions used to develop the
forward-looking statements, and material risk factors that could
cause actual results to differ materially from the forward-looking
statements, include but are not limited to, the validity of the
'907 and '285 Patents claims, the outcome of ongoing patent
litigation, the potential impact of COVID-19 on the Company's
operations, business and financial results and other factors, many
of which are beyond the control of Miravo. Additional factors
that could cause Miravo'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
Miravo's most recent Annual Information Form dated February 24, 2020 under the heading "Risks
Factors", and as described from time to time in the reports and
disclosure documents filed by Miravo with Canadian securities
regulatory agencies and commissions. These and other factors should
be considered carefully and readers should not place undue reliance
on Miravo's forward-looking statements. Forward-looking statements
should not be read as guarantees of future performance or results
and will not necessarily be accurate indications of whether or not
the times at or by which such performance or results will be
achieved.
All forward-looking statements are based only on information
currently available to the Company and are made as of the date of
this press release. Except as expressly required by applicable
Canadian securities law, the Company assumes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise. All
forward-looking statements in this press release are qualified by
these cautionary statements.
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SOURCE Nuvo Pharmaceuticals Inc.