- First Asian Partnering Deal for
Suvexx -
- Up to EUR 1.1
million in upfront and milestone payments -
MISSISSAUGA, ON, July 29, 2021 /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 SK Chemicals Co.,
Ltd. ("SK Chemicals") for the exclusive right to commercialize
Suvexx in the Republic of South
Korea (the "Territory").
SK Chemicals is headquartered in Seongnam, South Korea and is part of the SK Group, a
major South Korean conglomerate that generated over US$105 billion in revenue in 2020. SK Chemicals
generated US$1.0 billion in sales in
2020 and has Korean partnerships with many multinational
pharmaceutical companies including Eli Lilly, AstraZeneca and
Janssen.
The commercial launch of Suvexx in the Territory is anticipated
to commence in 2023, subject to receipt of regulatory approval from
the local regulatory authorities. Upon regulatory approval,
Suvexx is anticipated to be entitled to 6 years of marketing
exclusivity in the Territory. The South Korean prescription
acute migraine treatment market was valued at over US$20 million in 2020 based on IQVIA domestic
data.
"This agreement with SK Chemicals provides Suvexx with
access to the dynamic and growing acute migraine market in
South Korea," said Jesse Ledger, Miravo's President &
CEO. "SK Chemicals is a strong partner for Suvexx in
South Korea with their
complementary CNS product portfolio, and we are pleased to add them
to our growing roster of Suvexx partners."
License Agreement Details
The License Agreement grants SK Chemicals the exclusive rights
to commercialize Suvexx in the Territory. SK Chemicals 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 1.1 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 SK Chemicals Co., Ltd.
SK Chemicals is committed to perform practices from research
& development to marketing activities in South Korea. The company is well known
for extensive domestic market coverage with talented sales
representatives, facilitating the company's balanced pipeline.
As an affiliate of SK Group, the huge conglomerate in Korea
having total revenue over US$105
billion as of year 2020, SK Chemicals has been rapidly
growing its Life Science business domain and its annual sales
reached US$1.0 billion in year
2020. SK Chemicals is committed to both R& D and
marketing activities with its vision to become a leading global
total healthcare solutions provider. Through such commitment,
SK Chemicals has grown into one of the major pharmaceutical
companies in Korea since its establishment in 1969. For
further information of SK Chemicals, you can visit our website,
www.skchemicals.com/en/.
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. These forward-looking statements
include statements regarding: the anticipated timing for the
commercial launch of Suvexx in the Territory, the anticipated
receipt of regulatory approvals for Suvexx, the expected marketing
exclusivity granted for Suvexx within the Territory, and the
receipt of regulatory and sales-based milestone payments, royalties
on net sales, and revenue pursuant to the supply of Suvexx.
Forward-looking statements are not historical facts but
instead represent management's expectations, estimates and
projections regarding future events or circumstances. 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, delays in the
commercial launch of Suvexx in the Territory, the failure to
receive anticipated regulatory approvals for Suvexx, the loss of
exclusivity granted for Suvexx within the Territory, the failure to
achieve certain milestones with respect to Suvexx, 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 the Company. Additional factors that could cause
the Company'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 the Company's
most recent Annual Information Form dated March 5, 2021 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. 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/miravo-healthcaretm-ireland-enters-into-suvexx-license-and-supply-agreement-with-sk-chemicals-co-ltd-for-south-korea-301344760.html
SOURCE Nuvo Pharmaceuticals Inc.