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
chronic kidney disease, today announced the appointments of Jay D.
Kranzler, M.D., Ph.D., as Chairman and Chief Executive Officer and
Vibeke Strand, M.D., MACR, FACP, Adjunct Clinical Professor,
Division of Immunology/Rheumatology, Stanford University, to its
Board of Directors.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman
and Chief Executive Officer and Board Member of Urica, said, “We
are pleased to welcome Jay as Chairman and Chief Executive Officer
of Urica and Vibeke to the Board. Jay has been an important advisor
to Fortress over the past few years. His extensive experience
across all aspects of drug development will add significant value
as Urica advances dotinurad for the treatment of gout and possibly
other hyperuricemic indications including chronic kidney disease
and heart failure. We are equally thrilled to add Vibeke to the
Board given her vast knowledge in rheumatology. Her clinical
research and regulatory strategy expertise will be invaluable as
dotinurad continues to progress through clinical development. We
look forward to the anticipated announcement of topline data from
our Phase 1 trial in the second half of 2022.”
Dr. Kranzler has been a Founder, Chief Executive
Officer, Board Member and Advisor to leading life science companies
for over 30 years. Dr. Kranzler joins Urica to guide and expedite
the development of its lead product candidate, dotinurad, a
potential best-in-class urate transporter (URAT1) inhibitor that is
currently in Phase 1 clinical trials and positioned for the
treatment of gout in the United States. Dotinurad (URECE® tablet in
Japan) 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.
“I am gratified to be extending my engagement
with Fortress to lead its newest subsidiary and manage development
of such a promising technology. With an experienced team, we are
well positioned to replicate the exceptional clinical efficacy and
safety profile that dotinurad has already demonstrated in Japanese
trials and clinical use,” said Dr. Kranzler. “With success, we hope
to expand treatment options for the nearly 10 million patients
suffering from gout in the Unites States, in addition to the 10
million patients in our other licensed territories, and possibly
explore efficacy in other hyperuricemic indications, while creating
value for shareholders.”
Dr. Kranzler has served in operational and
consulting capacities for multiple large pharmaceutical companies,
small biotechnology companies, investment banks and investors. He
has developed drugs, medical devices and diagnostics, and is an
inventor on multiple key patents. Dr. Kranzler serves as an Adjunct
Professor at New York University Stern School of Business and at
the New York University Langone School of Medicine. Previously, Dr.
Kranzler was Vice President and Global Head of External R&D
Innovation and Worldwide R&D Strategic Investments at Pfizer.
His entrepreneurial career includes his role as Founder and Chief
Executive Officer of Cypress Bioscience, where he was credited for
the development of Savella™ (milnacipran) for the treatment of
fibromyalgia. He also served as Chief Executive Officer of Cytel
Corporation and was a Founder of Perception Neuroscience, which was
acquired by ATAI Life Sciences. Dr. Kranzler started his career at
McKinsey & Company where he was a key member of the team that
established the firm’s pharmaceutical practice. He is currently a
Board Member of Avenue Therapeutics (Nasdaq: ATXI), Baergic Bio,
Pastorus, Navitas and ImmunoBrain Checkpoint. Dr. Kranzler
graduated from Yale University School of Medicine with M.D. and
Ph.D. degrees with a focus in psychopharmacology.
Dr. Vibeke Strand has served as an adjunct
clinical professor in the Division of Immunology and Rheumatology
at Stanford University School of Medicine since 1993. For several
decades, she has led a consulting practice offering clinical
research and regulatory strategy expertise to pharmaceutical and
biotech with a focus on translating basic research into rational
design of randomized controlled trials, evaluation of their results
and defense of novel products in rheumatology to the U.S. Food and
Drug Administration and European Medicines Agency. She has
participated in the successful development of DMARDs, biologics and
JAK inhibitors in an array of rheumatoid conditions and
biosimilars. Dr. Strand has authored more than 500 publications, is
a Fellow of the American College of Physicians, Master of the
American College of Rheumatology and member of the Cosmos Club. She
received her B.A. from Swarthmore College and her M.D. from
University of California San Francisco School of Medicine.
“I look forward to working with Urica and my
fellow board members as we advance the development of dotinurad, an
innovative therapy that holds the potential to address the needs of
multiple patient populations requiring more effective treatment,”
said Dr. Strand.
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. 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 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 U.S.
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 chronic kidney disease.
Urica acquired the rights to develop and commercialize Dotinurad, a
potentially best-in-class URAT1 inhibitor, in the United States,
United Kingdom, European Union and Canada 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 nine 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 Contacts:Jaclyn Jaffe and Bill
BegienFortress 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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