Urica Therapeutics Expands Exclusive License Agreement with Fuji Yakuhin Co. Ltd. to Develop Dotinurad in Additional Territories Including Turkey and the Middle East and North Africa
December 14 2022 - 08:00AM
Urica Therapeutics, Inc. (“Urica” or the “Company”) (formerly known
as UR-1 Therapeutics, Inc.), a Fortress Biotech, Inc. (Nasdaq:
FBIO) (“Fortress”) subsidiary company focused on the development
and commercialization of pharmaceutical products to treat gout and
other conditions associated with hyperuricemia, today announced
that the Company has expanded its exclusive license agreement with
Fuji Yakuhin Co. Ltd. (“Fuji”) for the development of dotinurad to
include the Middle East and North Africa (“MENA”) and Turkey
territories. The agreement builds upon the exclusive license
agreement between Urica and Fuji previously announced in May of
2021 to develop dotinurad in the United States (“US”), United
Kingdom, European Union and Canada.
Under the terms of the agreement, the Company
acquired exclusive development and marketing rights in MENA and
Turkey from Fuji. Fuji is eligible to receive upfront and royalty
payments from the Company.
Jay D. Kranzler, M.D., Ph.D., Urica’s Chairman
and Chief Executive Officer, said, “We continue to have a very
collaborative relationship with Fuji and we are pleased to expand
the license agreement to include additional territories. MENA and
Turkey have a combined population of over 550 million, with limited
therapeutic options for the treatment of gout. We expect to
leverage the substantial preclinical and clinical data generated
to-date and work with local regulatory authorities across the
territory to expedite the approval process for dotinurad within
these territories in the near-term. We hope to advance these
discussions quickly and file the relevant marketing applications as
soon as possible.”
Dotinurad is a potential best-in-class urate
transporter (URAT1) inhibitor that is currently in a
Urica-sponsored Phase 1 clinical trial in the US and being
developed for the treatment of gout. Dotinurad (URECE® tablet in
Japan) was approved and launched in Japan in 2020 as a once-daily
oral therapy for gout and hyperuricemia. Dotinurad was efficacious
and well-tolerated in more than 1,000 Japanese patients treated for
up to 58 weeks in Fuji’s clinical program. Urica expects to
leverage data from the three completed Phase 3 clinical trials in
more than 500 Japanese patients in furthering the development and
marketing of dotinurad in the licensed territories.
About DotinuradIn May 2021,
Fortress announced an exclusive license agreement between its
subsidiary, Urica Therapeutics, Inc. (formerly UR-1 Therapeutics,
Inc.), and Fuji Yakuhin Co. Ltd. to develop dotinurad in North
America and Europe. In November 2022, Urica licensed rights to
dotinurad from Fuji for additional territories including MENA and
Turkey. Dotinurad is a potential best-in-class urate transporter
(URAT1) inhibitor for gout and possibly other hyperuricemic
indications including chronic kidney disease and heart failure. It
can lower blood uric acid levels by selectively inhibiting URAT1
and uric acid reabsorption in the kidneys. Dotinurad (URECE®
tablet) was approved in Japan in 2020 as a once-daily oral therapy
for gout and hyperuricemia. Dotinurad was efficacious and
well-tolerated in more than 500 Japanese patients treated for up to
58 weeks in Phase 3 clinical trials. Its efficacy demonstrated
non-inferiority to Febuxostat, which has a black box warning in the
US for increased risk of cardiovascular death, and dotinurad was
well-tolerated with apparent low safety risk and drug
interaction.1,2,3 Over 1,000 Japanese patients have been treated
safely with dotinurad in clinical trials. Also, dotinurad is
currently in Phase 3 clinical trials in China.
About GoutGout is a serious,
progressive and debilitating inflammatory arthritis caused by
deposits of uric acid crystal in and around the connective tissue
of joints, tendons and the kidneys. There are nearly 20 million
diagnosed patients with gout in the US, Europe and Canada as of
2021,4,5,6 and it is estimated that two to three million US
patients are unsatisfied with their urate-lowering therapy and
their serum uric acid levels remain inadequately controlled.7,8
About Urica TherapeuticsUrica
Therapeutics, Inc. (“Urica”) is a clinical-stage biopharmaceutical
company that focuses on the development and commercialization of
pharmaceutical products to treat gout and other conditions
associated with hyperuricemia. Urica acquired the rights to develop
and commercialize Dotinurad, a potentially best-in-class URAT1
inhibitor, in the United States, United Kingdom, European Union,
Canada, Middle East and North Africa (MENA) and Turkey from Fuji
Yakuhin. Dotinurad has been approved to treat gout and
hyperuricemia in Japan and is currently in a Phase 1 clinical trial
in the United States. Urica was founded by Fortress Biotech, Inc.
(Nasdaq: FBIO).
About Fortress Biotech Fortress
Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical
company focused on acquiring, developing and commercializing
high-potential marketed and development-stage drugs and drug
candidates. The company has eight marketed prescription
pharmaceutical products and over 30 programs in development at
Fortress, at its majority-owned and majority-controlled partners
and subsidiaries and at partners and subsidiaries it founded and in
which it holds significant minority ownership positions. Such
product candidates span six large-market areas, including oncology,
rare diseases and gene therapy, which allow it to create value for
shareholders. Fortress advances its diversified pipeline through a
streamlined operating structure that fosters efficient drug
development. The Fortress model is driven by a world-class business
development team that is focused on leveraging its significant
biopharmaceutical industry expertise to further expand the
company’s portfolio of product opportunities. Fortress has
established partnerships with some of the world’s leading academic
research institutions and biopharmaceutical companies to maximize
each opportunity to its full potential, including AstraZeneca plc,
City of Hope, Fred Hutchinson Cancer Research Center, St. Jude
Children’s Research Hospital, Nationwide Children’s Hospital and
Sentynl Therapeutics, Inc. For more information, visit
www.fortressbiotech.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, as amended. As used
below and throughout this press release, the words “we”, “us” and
“our” may refer to Fortress individually or together with one or
more partner companies, as dictated by context. Such statements
include, but are not limited to, any statements relating to our
growth strategy and product development programs, ability to
generate shareholder value, ability of our products to receive
necessary approvals, including FDA, ability of our products and
therapies to help patients and any other statements that are not
historical facts. Forward-looking statements are based on
management’s current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock price. Factors that could
cause actual results to differ materially from those currently
anticipated include: risks relating to our growth strategy; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the
results of research and development activities; uncertainties
relating to preclinical and clinical testing; risks relating to the
timing of starting and completing clinical trials, including
disruptions that may result from hostilities in Europe; our
dependence on third-party suppliers; risks relating to the COVID-19
outbreak and its potential impact on our employees’ and
consultants’ ability to complete work in a timely manner and on our
ability to obtain additional financing on favorable terms or at
all; our ability to attract, integrate and retain key personnel;
the early stage of products under development; our need for
substantial additional funds; government regulation; patent and
intellectual property matters; competition; as well as other risks
described in our SEC filings. We expressly disclaim any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as may
be required by law, and we claim the protection of the safe harbor
for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.
Company Contact:Jaclyn JaffeFortress Biotech,
Inc.(781) 652-4500ir@fortressbiotech.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
References
- Clin Exp Nephrol. 2020 Mar;24(Suppl
1):71-79.
- Clin Exp Nephrol. 2020 Mar;24(Suppl
1):62-70.
- Clin Exp Nephrol. 2020 Mar;24(Suppl
1):80-91.
- Rheumatology (Oxford). 2019 Dec
1;58(12):2177-2180.
- Semin Arthritis Rheum. 2017 Feb;
46(4): 451–456.
- GlobalData. Gouty Arthritis (Gout):
Competitive Landscape in 2021.
- Arthritis Rheumatol. 2019 Jun;
71(6): 991–999.
- J Rheumatol. 2016
Oct;43(10):1897-1903.
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