- Commercial launch anticipated in
Summer 2021 -
MISSISSAUGA, ON, March 1, 2021 /PRNewswire/ - Nuvo Pharmaceuticals
Inc. (TSX: MRV) (OTCQX: MRVFF) 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 The Mentholatum
Company for the exclusive right to commercialize the Resultz
formula and technology in the United
States under the
Mentholatum® brand.
The Mentholatum Company, a global, U.S.-based company is focused
on the commercialization of innovative consumer healthcare brands,
such as the Mentholatum brand with more than 130 years in the U.S.
market and a strong equity and trust among American families.
Resultz is cleared for marketing as a Class 1 medical device by
the United States Food and Drug Administration. The U.S.
commercial launch is anticipated to commence during the summer of
2021. The non-prescription head lice treatment market in the
U.S. was valued at over US$125
million in the past 12 months based on Company
estimates.
"The combination of The Mentholatum Company's experience in
launching new and innovative consumer health products, plus the
strong equity of the Mentholatum brand makes them an ideal partner
for Resultz in the U.S.," said Jesse
Ledger, Miravo's President & CEO. "The upcoming
commercial launch of Resultz leveraging the Mentholatum brand in
the U.S. marks another important milestone in the expansion of
Miravo's international Licensing and Royalty Business
segment."
License Agreement Details
The License Agreement grants
The Mentholatum Company the exclusive rights to import, market,
sell and distribute Resultz.in the U.S. The Mentholatum
Company will manage all U.S. specific commercial activities.
Miravo Ireland will receive revenue pursuant to the supply of
finished product to The Mentholatum Company. The COVID-19
pandemic has created some uncertainty regarding the traditional
seasonal demand for head lice treatments. Due to physical
distancing regulations currently being enforced, many children in
the U.S. are not physically attending school or daycare and are not
able to participate in group activities, the traditional
environments where head lice outbreaks occur. The License
Agreement has been structured with an 18-month term, which will
allow both parties to reassess market dynamics related to the
COVID-19 pandemic and to determine if a longer-term agreement is
warranted in a post-pandemic commercial environment. Resultz
is currently manufactured by the Company's contract manufacturing
partner in Europe.
About Resultz
Resultz is a pesticide-free pediculicide
rinse that addresses the challenge of increasing pesticide
resistance in lice and concerns about patient safety through
exposure to pesticides. In as little as a 5-minute
application (the shortest treatment time for head lice products in
the U.S.), Resultz acts to disrupt the wax covering of the head
louse resulting in their dehydration and death. Resultz lice
and egg removal kit facilitates removal of lice, nymphs and nits
with efficacy of up to 100% when used as directed. If
necessary, a second application approximately 7-10 days later will
eliminate any remaining lice. The Resultz lice and egg
removal kit and its unique physical mechanism of action allows
Resultz to work even with pesticide resistant super lice.
Resultz is indicated for treating both children and adults.
It has an excellent safety profile and contains active
ingredients commonly found in many cosmetic products. Resultz
was first launched in the United
Kingdom and Ireland in 2005
and more than ten million patients have been treated globally
to-date. Current global licensees include Reckitt Benckiser
Group PLC, Heumann Pharma GmbH & Co. and Fagron Belgium NV.
Resultz is also pending registration in Japan, where the local license is held by Sato
Pharmaceutical Co. Ltd. Resultz is protected by a portfolio
of 35 issued patents globally.
About The
Mentholatum® Brand
Since 1889,
mothers have soothed their children when they were sick with
Mentholatum chest rubs – applied with the power of a loving touch.
In the U.S., Mentholatum is a topical relief expert
addressing common cough and cold symptoms with natural menthol
remedies, while being a highly trusted family brand passed from
generation to generation. The trust mom has that Mentholatum
will help them take care of themselves and their families as a home
staple brand has allowed Mentholatum to expand its equity into
different segments globally (including skin care, lip care, pain
relief, personal products, and cough and cold treatments). In
the U.S. in 2020, Resultz, branded as Mentholatum Lice, showed a
very strong purchase interest among moms in quantitative research
conducted by The Mentholatum Company.
About Miravo Healthcare
Miravo is a Canadian focused,
healthcare company with global reach and a diversified portfolio of
commercial products. The Company's products target several
therapeutic areas, including pain, allergy, neurology 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.
About The Mentholatum Company
Mentholatum was founded
in 1889 in Wichita, Kansas and
grew into a global health and wellness company with a reputation
for quality and value. In 1988, Rohto Pharmaceutical Company,
Ltd. acquired The Mentholatum Company. Rohto Pharmaceutical
Company, Ltd. was founded in 1899 in Osaka, Japan, and today it is the second
largest consumer health company in Japan, commercializing with The Mentholatum
Company in more than 110 countries. Establishing its position
as a global health and wellness company, Rohto provides
non-prescription pharmaceutical, healthcare, and cosmetic products
worldwide. Driven by scientific research, technology, and
keeping a pulse on consumers' aspirations, The Mentholatum Company
is dedicated to providing effective solutions for consumers'
personal needs through developing high quality, innovative new
products. The Mentholatum Company in the U.S. commercializes a
number of recognized, national brands, including Oxy®
Acne Medications, Mentholatum®, Softlips® Lip
Care, Hada Labo Tokyo™ Skin Care, Red Cross® Oral Care,
Rohto® Cooling Eye Drops and Phisoderm® among
other brands.
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 launch of Resultz in the
United States, the potential impacts of COVID-19 and related
public health policies on sales of Resultz and the possibility that
the Company and The Mentholatum Company may enter into an amended
or new long-term supply agreement. 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 launching Resultz in the United
States, interruptions in supply chains and other delays in
the supply of finished products and samples to The Mentholatum
Company, prolonged or unexpected adverse impacts of COVID-19 and
related public health policies on the market for head lice
treatment in the United States and
sales of Resultz in the United
States, the inability or unwillingness of the Company or The
Mentholatum Company to agree on an amended or new longer-term
agreement, and other adverse impacts (including the prolonged or
unexpected impact of COVID-19) on the Company's, the Company's
contract manufacturing partner's and The Mentholatum 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
February 24, 2020 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.
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SOURCE Nuvo Pharmaceuticals Inc.