Resultz was FDA cleared in May 2017
- Company now owns Resultz
product rights globally -
- Opens access to ~US$255 million head lice market -
MISSISSAUGA, ON, Jan. 15, 2018 /PRNewswire/ - 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 that its wholly owned subsidiary, Nuvo
Pharmaceuticals (Ireland) Limited
(Nuvo Ireland) has acquired the U.S. rights to Resultz®
(50% isopropyl myristate, 50% cyclomethicone D5 topical solution
lice and egg removal kit) from Piedmont Pharmaceuticals LLC
(Piedmont). The acquisition
includes all U.S. product and intellectual property rights and is a
complementary follow-on to Nuvo's acquisition of the global,
ex-U.S. Resultz product rights announced on January 2, 2018. Nuvo now owns all Resultz
product and intellectual property rights throughout the world.
Resultz is a commercial-stage, best-in-class, clinically proven,
safe, non-pesticide, over-the-counter (OTC) treatment for head
lice. Resultz was cleared as a Class 1 medical device by the
U.S. Food and Drug Administration (FDA) in May 2017 and has not yet been commercially
launched in the U.S. The topical head lice market in the U.S.
was valued at US$255 million in 2016,
inclusive of both prescription and OTC products. Resultz,
with its class-leading 5-minute application time, is well
positioned to enter this attractive market. Nuvo anticipates
commercializing Resultz in the U.S. through a licensing partner and
has already initiated discussions with potential licensees.
With this transaction, Nuvo gains global control of the Resultz
franchise and adds an additional FDA cleared U.S. product to its
growing commercial product portfolio. Alongside existing
manufacturing partners, Nuvo will be able to produce Resultz for
the U.S. market at its Varennes,
Québec manufacturing facility.
"We are thrilled to complete full ownership of the global
Resultz business through the acquisition of the U.S. rights for
Resultz," said Jesse Ledger, Nuvo's
President & CEO. "We believe the product attributes that
have made Resultz a market leader in Canada and Europe, where market capture rates have
reached as high as 35%, namely the class-leading 5-minute
application time, up to 100% efficacy and exceptional safety
profile as a non-pesticide treatment, will make it a success in
the United States as well.
Additionally, the team at Nuvo has been working hard for more
than a year, with discipline and clear criteria for strong
acquisition and in-licensing opportunities, and we are pleased to
have been able to deliver on several recent transactions as a
result, including the two Resultz transactions and international
Pennsaid 2% licensing transactions. We continue to review and
pursue multiple opportunities with that same focus and
discipline."
Purchase Agreement Details
Under the terms of the
agreement, US$1.5 million was paid to
Piedmont on close using existing
cash on hand. The transaction includes a single-digit royalty
payable by Nuvo Ireland on net sales through 2034. Nuvo,
through its Nuvo Ireland subsidiary, has also obtained a right of
first refusal to license or acquire certain related assets from
Piedmont targeting other human
indications. Nuvo now has cash and short-term investments of
approximately $8.3 million and no
debt with an unused $6.0 million line
of credit, which positions Nuvo to acquire additional products and
businesses from existing resources.
Stifel, Nicolaus & Company, Incorporated acted as exclusive
financial advisor to Piedmont Pharmaceuticals LLC in this
transaction.
About Resultz
Resultz is a pesticide-free pediculicide
rinse which was originally developed by Piedmont 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 application time for
head lice products), 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 % in as little as 5
minutes. 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 as a medical device 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, Aralez
Pharmaceuticals Inc. and Lapidot Medical. Resultz is also
pending registration in Japan,
where the local license is held by Sato Pharmaceutical Co.
Ltd. Resultz is protected by a robust portfolio of 40 issued
patents globally, including two U.S. patents which provide
protection through to 2022 and 2024, respectively.
About Piedmont Pharmaceuticals LLC
Piedmont
Pharmaceuticals has been committed to seeking regulatory approval
and commercializing the Resultz Brand globally. It is closely
affiliated with Piedmont Animal Health which at one time was a
wholly owned subsidiary. Piedmont Animal Health LLC is a
Greensboro, N.C.-based companion
animal pharmaceutical development and marketing company focused on
inventing and developing innovative technologies to address
veterinary healthcare needs. Piedmont's founders have developed, launched,
and/or marketed over 20 FDA Rx companion animal products for dogs,
cats, and horses, including four innovative products developed and
launched in the U.S. by Piedmont Animal Health in the last four
years. The company is currently developing a broad range of
convenient and long-acting medications, including ones focusing on
the therapeutic areas of pain management and anti-infectives.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX: NRI; OTCQX:
NRIFF) is a global commercial healthcare company with a portfolio
of commercial products and pharmaceutical manufacturing
capabilities. Nuvo has four commercial products that are
available in a number of countries; Pennsaid® 2%,
Pennsaid, Resultz 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
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Forward-looking statements are neither historical facts nor
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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
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considered carefully and readers should not place undue reliance on
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results, levels of activity or achievements and none of Nuvo or any
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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
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whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
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SOURCE Nuvo Pharmaceuticals Inc.