Travere Therapeutics, Inc., (NASDAQ: TVTX) announced that it has
entered into an exclusive licensing agreement with Renalys Pharma,
Inc., to bring sparsentan, a dual endothelin angiotensin receptor
antagonist for the treatment of IgA nephropathy, to patients in
Japan and other countries in Asia. Renalys will hold regional
rights to sparsentan for Japan, South Korea, Taiwan, Brunei,
Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines,
Singapore, Thailand, and Vietnam.
“We’re pleased to partner with Renalys, a
company led by distinguished renal experts with a strong track
record of launching kidney disease treatments,” said Eric Dube,
Ph.D., president and chief executive officer of Travere
Therapeutics. “Renalys Pharma has the expertise and resources to
rapidly advance sparsentan to enable people living with IgAN in
Japan and other Asian countries to have access to this innovative
therapy as quickly as possible.”
Following successful meetings with the
Pharmaceuticals and Medical Devices Agency (PMDA) in 2023, Renalys
plans to initiate an open label registrational study of sparsentan
in Japan in the second quarter of 2024 to support potential
approval of sparsentan in Japan. Results from the urine
protein/creatinine ratio (UP/C) endpoint in the study are expected
in the second half of 2025 to support a submission for approval to
PMDA.
Under the terms of the agreement, Travere will
receive an upfront payment and be eligible to receive up to $120
million in regulatory, development and sales-based milestone
payments. As part of the collaboration, Travere has obtained a
minority equity stake in Renalys and will be eligible to receive
tiered royalties on net sales of sparsentan in Japan, South Korea,
Taiwan, and the specified Southeast Asian nations. Renalys will be
responsible for development, regulatory matters, and
commercialization in the licensed territories.
“As the first non-immunosuppressive treatment
for IgA nephropathy, and one that will likely be used in
combination therapy regimens as new agents are approved in the
future, sparsentan is - without question - the kind of foundational
medicine we are focused on bringing to Japan to stem the rising
tide of kidney failure due to IgAN,” said BT Slingsby, chief
executive officer of Renalys Pharma. “Travere is a long-known
leader in rare kidney disease, and we are proud to collaborate with
this team.”
About IgA Nephropathy
IgA nephropathy (IgAN), also called Berger's
disease, is a rare progressive kidney disease characterized by the
buildup of immunoglobulin A (IgA), a protein that helps the body
fight infections, in the kidneys. The deposits of IgA cause a
breakdown of the normal filtering mechanisms in the kidney, leading
to blood in the urine (hematuria), protein in the urine
(proteinuria) and a progressive loss of kidney function. Other
symptoms of IgAN may include swelling (edema) and high blood
pressure.
IgAN is the most common type of primary
glomerulonephritis worldwide and a leading cause of kidney failure
due to glomerular disease.
About Travere Therapeutics
At Travere Therapeutics, we are in rare for
life. We are a biopharmaceutical company that comes together every
day to help patients, families and caregivers of all backgrounds as
they navigate life with a rare disease. On this path, we know the
need for treatment options is urgent – that is why our global team
works with the rare disease community to identify, develop and
deliver life-changing therapies. In pursuit of this mission, we
continuously seek to understand the diverse perspectives of rare
patients and to courageously forge new paths to make a difference
in their lives and provide hope – today and tomorrow. For more
information, visit travere.com.
About Renalys Pharma
Renalys Pharma is a private, late-stage clinical
biopharmaceutical company in Japan committed to the development of
multiple innovative therapeutics that address unmet needs in the
management of renal disease for Japanese and Asian patients. It was
co-founded by life sciences investment firms Catalys Pacific and SR
One.
FILSPARI®
(sparsentan) U.S. Indication
FILSPARI is an endothelin and angiotensin II
receptor antagonist indicated to reduce proteinuria in adults with
primary immunoglobulin A nephropathy (IgAN) at risk of rapid
disease progression, generally a UPCR ≥1.5 g/g.
This indication is granted under accelerated
approval based on reduction in proteinuria. It has not been
established whether FILSPARI slows kidney function decline in
patients with IgAN. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory clinical trial.
FILSPARI®
(sparsentan) Important Safety Information
BOXED WARNING: HEPATOTOXICITY AND
EMBRYO-FETAL TOXICITYBecause of the risks of
hepatotoxicity and birth defects, FILSPARI is available only
through a restricted program called the FILSPARI REMS. Under the
FILSPARI REMS, prescribers, patients and pharmacies must enroll in
the program.
HepatotoxicitySome
Endothelin Receptor Antagonists (ERAs) have caused elevations of
aminotransferases, hepatotoxicity, and liver failure. In clinical
studies, elevations in aminotransferases (ALT or AST) of at least
3-times the Upper Limit of Normal (ULN) have been observed in up to
2.5% of FILSPARI-treated patients, including cases confirmed with
rechallenge.
Measure transaminases and bilirubin
before initiating treatment and monthly for the first 12 months,
and then every 3 months during treatment. Interrupt treatment and
closely monitor patients who develop aminotransferase elevations
more than 3x ULN.
FILSPARI should generally be avoided in
patients with elevated aminotransferases (>3x ULN) at baseline
because monitoring for hepatotoxicity may be more difficult and
these patients may be at increased risk for serious
hepatotoxicity.
Embryo-Fetal
ToxicityFILSPARI can cause major birth defects if
used by pregnant patients based on animal data. Therefore,
pregnancy testing is required before the initiation of treatment,
during treatment and one month after discontinuation of treatment
with FILSPARI. Patients who can become pregnant must use effective
contraception before the initiation of treatment, during treatment,
and for one month after discontinuation of treatment with
FILSPARI.
Contraindications: FILSPARI is
contraindicated in patients who are pregnant. Do not coadminister
FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or
aliskiren.
Warnings and Precautions
Hepatotoxicity: Elevations in ALT or AST of at
least 3-fold ULN have been observed. To reduce the risk of
potential serious hepatotoxicity, measure serum aminotransferase
levels and total bilirubin prior to initiation of treatment,
monthly for the first 12 months, then every 3 months during
treatment.
Advise patients with symptoms suggesting
hepatotoxicity (nausea, vomiting, right upper quadrant pain,
fatigue, anorexia, jaundice, dark urine, fever, or itching) to
immediately stop treatment with FILSPARI and seek medical
attention. If aminotransferase levels are abnormal at any time
during treatment, interrupt FILSPARI and monitor as
recommended.
Consider re-initiation of FILSPARI only when
hepatic enzyme levels and bilirubin return to pretreatment values
and only in patients who have not experienced clinical symptoms of
hepatotoxicity.
Avoid initiation of FILSPARI in patients with
elevated aminotransferases (>3x ULN) prior to drug
initiation.
Embryo-Fetal Toxicity: FILSPARI
can cause fetal harm. Advise patients who can become pregnant of
the potential risk to a fetus. Obtain a pregnancy test and advise
patients who can become pregnant to use effective contraception
prior to, during, and one month after discontinuation of FILSPARI
treatment.
FILSPARI REMS: FILSPARI is
available only through a restricted program under a REMS called the
FILSPARI REMS.
Important requirements include:
- Prescribers must be certified with the FILSPARI REMS by
enrolling and completing training.
- All patients must enroll in the FILSPARI REMS prior to
initiating treatment and comply with monitoring requirements.
- Pharmacies that dispense FILSPARI must be certified with the
FILSPARI REMS and must dispense only to patients who are authorized
to receive FILSPARI.
Further information is available at
www.filsparirems.com or 1-833-513-1325.
Hypotension: There was a
greater incidence of hypotension-associated adverse events, some
serious, including dizziness, in patients treated with FILSPARI
compared to irbesartan. In patients at risk for hypotension,
consider eliminating or adjusting other antihypertensive
medications and maintaining appropriate volume status. If
hypotension develops, consider a dose reduction or dose
interruption of FILSPARI.
Acute Kidney Injury: Monitor
kidney function periodically. Patients whose kidney function may
depend in part on the activity of the renin-angiotensin system
(e.g., patients with renal artery stenosis, chronic kidney disease,
severe congestive heart failure, or volume depletion) may be at
particular risk of developing acute kidney injury on FILSPARI.
Consider withholding or discontinuing therapy in patients who
develop a clinically significant decrease in kidney function while
on FILSPARI.
Hyperkalemia: Monitor serum
potassium periodically and treat appropriately. Patients with
advanced kidney disease, taking concomitant potassium-increasing
drugs (e.g., potassium supplements, potassium-sparing diuretics),
or using potassium-containing salt substitutes are at increased
risk for developing hyperkalemia. Dosage reduction or
discontinuation of FILSPARI may be required.
Fluid Retention: Fluid
retention may occur with ERAs, and has been observed with FILSPARI.
If clinically significant fluid retention develops, after
evaluation, consider modifying the dose of FILSPARI.
Most common adverse reactions (5%) with
FILSPARI are peripheral edema, hypotension (including
orthostatic hypotension), dizziness, hyperkalemia, and anemia.
Drug interactions
- Renin-Angiotensin System
(RAS) Inhibitors and ERAs: Do not coadminister FILSPARI
with angiotensin receptor blockers (ARBs), ERAs, or aliskiren.
- Strong and Moderate CYP3A
Inhibitors: Avoid concomitant use of FILSPARI with strong
CYP3A inhibitors. Monitor blood pressure, serum potassium, edema,
and kidney function regularly when used concomitantly with moderate
CYP3A inhibitors.
- Strong CYP3A
Inducers: Avoid concomitant use with a strong CYP3A
inducer.
- Antacids and Acid Reducing
Agents: Administer FILSPARI 2 hours before or after
administration of antacids. Avoid concomitant use of acid reducing
agents (histamine H2 receptor antagonist and PPI proton pump
inhibitor) with FILSPARI.
- Non-Steroidal
Anti-Inflammatory Agents (NSAIDs), Including Selective
Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of
worsening renal function.
- CYP2B6, 2C9, and 2C19
Substrates: Monitor for efficacy of the concurrently
administered CYP2B6, 2C9, and 2C19 substrates and consider dosage
adjustment in accordance with the Prescribing Information.
- P-gp and BCRP Substrates:
Avoid concomitant use of sensitive substrates of P-gp and
BCRP with FILSPARI.
- Agents Increasing Serum
Potassium: Monitor serum potassium frequently. Concomitant
use of FILSPARI with potassium-sparing diuretics, potassium
supplements, potassium-containing salt substitutes, or other drugs
that raise serum potassium levels may result in hyperkalemia.
Use in specific populations
- Pregnancy / Females and
Males of Reproductive Potential: FILSPARI can cause fetal
harm, including birth defects and fetal death, when administered to
a pregnant patient and is contraindicated during pregnancy.
- Pregnancy Testing /
Contraception: Verify the pregnancy status and effective
method of contraception prior to, during, and one month after
discontinuation of FILSPARI treatment. The patient should contact
their physician immediately for pregnancy testing if onset of
menses is delayed or pregnancy is suspected.
- Lactation: Advise
patients not to breastfeed during treatment with FILSPARI.
- Hepatic
Impairment: Avoid use of FILSPARI in patients with any
hepatic impairment (Child-Pugh class A-C).
Please see Full Prescribing Information
for FILSPARI here.
Forward-Looking StatementsThis
press release contains “forward-looking statements” as that term is
defined in the Private Securities Litigation Reform Act of 1995.
Without limiting the foregoing, these statements are often
identified by the words “on-track,” “positioned,” “look forward
to,” “will,” “would,” “may,” “might,” “believes,” “anticipates,”
“plans,” “expects,” “intends,” “potential,” or similar expressions.
In addition, expressions of our strategies, intentions or plans are
also forward-looking statements. Such forward-looking statements
include, but are not limited to, references to: the timing and
potential outcome of Renalys Pharma’s plans regarding a
registrational study and the potential approval of sparsentan for
IgA nephropathy in Japan; other statements regarding Renalys
Pharma’s capabilities and plans, including but not limited to its
development and commercialization plans and related expectations;
statements regarding potential future milestone and royalty-based
payments; statements regarding the potential use of sparsentan in
combination therapy; and statements regarding the potential for
sparsentan to be a foundational medicine in the applicable
territories. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them,
and could cause actual outcomes and results to differ materially
from current expectations. No forward-looking statement can be
guaranteed. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements are risks and uncertainties associated with the
regulatory review and approval process, as well as general risks
and uncertainties associated with the Company’s and Renalys’s
business, finances, and pipeline. Specifically, the Company faces
risks associated with market acceptance of its commercial products
including efficacy, safety, price, reimbursement, and benefit over
competing therapies, as well as risks associated with the
successful development and execution of commercial strategies for
such products, including FILSPARI. The risks and uncertainties the
Company faces with respect to its preclinical and clinical stage
pipeline include risk that the Company’s clinical candidates will
not be found to be safe or effective and that current or
anticipated future clinical trials will not proceed as planned.
Specifically, the Company faces risks related to the timing and
potential outcome of its licensees’ development, regulatory and
commercialization activities in licensed territories, the timing
and potential outcome of its planned sNDA submission for full
approval of sparsentan in IgAN, and the risk that the results from
the Phase 3 DUPLEX Study of sparsentan in FSGS will not serve as a
basis for a regulatory submission for approval of sparsentan for
FSGS. There is no guarantee that regulators will grant full
approval of sparsentan for IgAN or FSGS. The Company also faces the
risk that its cash runway might not last as long as currently
anticipated and the risk that it will be unable to raise additional
funding that may be required to complete development of any or all
of its product candidates, including as a result of macroeconomic
conditions; risks relating to the Company’s dependence on
contractors for clinical drug supply and commercial manufacturing;
uncertainties relating to patent protection and exclusivity periods
and intellectual property rights of third parties; risks associated
with regulatory interactions; and risks and uncertainties relating
to competitive products, including current and potential future
generic competition with certain of the Company’s products, and
technological changes that may limit demand for the Company’s
products. The Company also faces additional risks associated with
global and macroeconomic conditions, including health epidemics and
pandemics, including risks related to potential disruptions to
clinical trials, commercialization activity, supply chain, and
manufacturing operations. You are cautioned not to place undue
reliance on these forward-looking statements as there are important
factors that could cause actual results to differ materially from
those in forward-looking statements, many of which are beyond our
control. The Company undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events, or otherwise. Investors are referred to
the full discussion of risks and uncertainties, including under the
heading “Risk Factors”, as included in the Company’s most recent
Form 10-K, Form 10-Q and other filings with the Securities and
Exchange Commission.
Contact Info
Media:888-969-7879mediarelations@travere.com |
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Investors:888-969-7879IR@travere.com |
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