- Sparsentan is a potential first-in-class treatment to
address significant unmet medical need in rare kidney disorders
focal segmental glomerulosclerosis (FSGS) and IgA nephropathy
(IgAN)
- Vifor Pharma obtains exclusive commercialization rights for
sparsentan in Europe, Australia and New Zealand
- Travere receives a USD 55 million upfront payment and is
eligible for additional regulatory and commercial milestones, as
well as tiered royalties on net sales
Regulatory News:
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210915005966/en/
AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
Vifor Pharma Group and Travere Therapeutics, Inc. (NASDAQ: TVTX)
today announced the companies have entered into a joint
collaboration and licensing agreement for the commercialization of
sparsentan in Europe, Australia and New Zealand. Sparsentan is a
novel investigational product candidate currently being evaluated
in pivotal phase-III clinical studies for the treatment of FSGS and
IgAN, two rare progressive kidney disorders and leading causes of
end-stage kidney disease. There are currently no approved medicines
indicated for FSGS or IgAN. Sparsentan has been granted Orphan Drug
Designation for the treatment of IgAN and FSGS in the U.S. and
Europe.
Under the terms of the agreement, Vifor Pharma will receive
exclusive commercialization rights for sparsentan in Europe,
Australia and New Zealand. Travere will receive an upfront payment
of USD 55 million and be eligible for up to USD 135 million in
payments tied to the achievement of certain regulatory and market
access related milestones. Vifor Pharma will also make further
payments in the form of sales milestones, and tiered double-digit
royalties on net sales of sparsentan in Europe, Australia and New
Zealand up to 40 percent at the high end of the royalty range.
“This agreement highlights that Vifor Pharma has become a
company of choice for organizations committed to partnering
innovative nephrology assets”, Abbas Hussain, CEO of Vifor Pharma
Group commented. “With sparsentan, we will further expand our
growing nephrology pipeline into FSGS and IgAN. There are currently
no effective or approved therapies for these two rare kidney
disorders, resulting in a significant unmet medical need among
these patient populations. We look forward to working closely with
Travere, who is responsible for the ongoing clinical development
program of sparsentan, and to leveraging our commercial expertise
to bring this highly promising, innovative treatment option to
potentially more than 150,000 patients living with IgAN or FSGS in
the licensed territories as soon as possible.”
“Our goal is for sparsentan to become the new global treatment
standard for people living with FSGS and IgAN; this collaboration
marks an important step forward in this journey,” said Eric Dube,
Ph.D., chief executive officer of Travere Therapeutics. “Vifor
Pharma is a global leader in nephrology with established
commercialization expertise in Europe, Australia and New Zealand
and this agreement aligns our two companies with the common goal of
maximizing the number of people who can access sparsentan, if
approved in these regions. In addition, this collaboration will
further strengthen our financial foundation and allow our
organization to focus on planned future launches of sparsentan in
the U.S.”
Following the recently announced positive topline interim
results from the ongoing pivotal phase-III PROTECT study of
sparsentan in IgAN, Travere and Vifor Pharma will further evaluate
the regulatory strategy for sparsentan in Europe, including the
potential to submit a joint marketing authorization application for
both FSGS and IgAN in 2022. Ultimately, the responsibility for and
control over marketing authorizations in the licensed territories
will be transitioned to Vifor Pharma. If sparsentan is approved,
Vifor Pharma will be responsible for all commercialization
activities in the licensed territories. Travere remains responsible
for the clinical development of sparsentan and will retain all
rights to sparsentan in the U.S. and rest of the world.
About Vifor Pharma Group Vifor Pharma Group is a
global pharmaceuticals company. It aims to become the global leader
in iron deficiency, nephrology and cardio-renal therapies. The
company is a partner of choice for pharmaceuticals and innovative
patient-focused solutions. Vifor Pharma Group strives to help
patients around the world with severe and chronic diseases lead
better, healthier lives. The company develops, manufactures and
markets pharmaceutical products for precision patient care. Vifor
Pharma Group holds a leading position in all its core business
activities and consists of the following companies: Vifor Pharma
and Vifor Fresenius Medical Care Renal Pharma (a joint company with
Fresenius Medical Care). Vifor Pharma Group is headquartered in
Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss
Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com.
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 sparsentan Sparsentan, a Dual Endothelin
Angiotensin Receptor Antagonist (DEARA), is a novel investigational
product candidate. Pre-clinical data have shown that blockade of
both endothelin type A and angiotensin II type 1 pathways in forms
of rare chronic kidney disease, reduces proteinuria, protects
podocytes and prevents glomerulosclerosis and mesangial cell
proliferation. Sparsentan has been granted Orphan Drug Designation
for the treatment of FSGS and IgAN in the U.S. and Europe.
Sparsentan is currently being evaluated in the pivotal phase-III
DUPLEX study for the treatment of FSGS and the pivotal phase-III
PROTECT study for the treatment of IgAN. In February 2021, Travere
announced that the ongoing DUPLEX study of sparsentan in FSGS
achieved its pre-specified interim FSGS partial remission of
proteinuria endpoint (FPRE) with statistical significance. FPRE is
a clinically meaningful endpoint defined as urine
protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent
reduction in UP/C from baseline. After 36 weeks of treatment, 42.0
percent of patients receiving sparsentan achieved FPRE, compared to
26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary
results from the interim analysis suggest that at the time of the
interim assessment, sparsentan had been generally well-tolerated
and shown a comparable safety profile to irbesartan. In August of
2021, Travere announced that the ongoing PROTECT study met its
pre-specified interim primary efficacy endpoint with statistical
significance, demonstrating a greater than threefold reduction of
proteinuria from baseline after 36 weeks of treatment, compared to
the active control irbesartan (p<0.0001). Preliminary results
from the interim analysis suggest that at the time of the interim
assessment, sparsentan had been generally well-tolerated and
performed consistent with the observed safety profile to date. In
the phase-II DUET study of sparsentan in FSGS, the combined
treatment group met its primary efficacy endpoint, demonstrating a
greater than two-fold reduction in proteinuria compared to
irbesartan, and was generally well tolerated after the eight-week,
double-blind treatment period. Irbesartan is part of a class of
drugs used to manage FSGS and IgAN in the absence of an approved
pharmacologic treatment. If approved for both indications,
sparsentan could potentially be the first medicine approved for
both FSGS and IgAN.
Forward Looking Statements This 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 "may", "might", "believes", "thinks", "anticipates",
"plans", "expects", "intends" 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: Travere’s goal for
sparsentan to become the new global treatment standard for people
living with FSGS and IgAN; the goal to maximize the number of
people who can access sparsentan, if approved in the licensed
regions; the ability of the collaboration to further strengthen
Travere’s financial foundation; planned future launches of
sparsentan in the U.S.; the potential to submit a joint marketing
authorization application for both FSGS and IgAN in 2022; Vifor’s
potential future achievement of regulatory, market-access and sales
based milestones and Travere’s potential future receipt of payments
therefrom; statements regarding the projected patient population in
the licensed territory if sparsentan is approved; references to the
efficacy, safety and tolerability profile of sparsentan based on
the preliminary data from the DUPLEX and PROTECT Studies’ interim
analyses; and the potential for sparsentan to become the first
medicine approved for both FSGS and IgAN. 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, including the
conditional marketing authorization pathway in Europe, and the
pricing and reimbursement landscape in the licensed territories, as
well as ongoing clinical development risk. There is no guarantee
that regulatory authorities in the licensed territories will accept
a marketing authorization application for sparsentan or that
sparsentan will receive conditional marketing authorization or be
approved at all. 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.
Travere 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 as included in Travere’s most
recent Form 10-K, Form 10-Q and other filings with the Securities
and Exchange Commission.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210915005966/en/
Media Relations Nathalie Ponnier Global Head Corporate
Communications +41 79 957 96 73 media@viforpharma.com
Investor Relations Julien Vignot Head of Investor
Relations +41 58 851 66 90 investors@viforpharma.com
Travere Therapeutics: Chris Cline, CFA Senior Vice
President, Investor Relations & Corporate Communications +1
888-969-7879 IR@travere.com
Travere Therapeutics (NASDAQ:TVTX)
Historical Stock Chart
From Apr 2024 to May 2024
Travere Therapeutics (NASDAQ:TVTX)
Historical Stock Chart
From May 2023 to May 2024