Calliditas announces that it has entered into an agreement
with Viatris to bring Nefecon®, a specialty therapy focused on
downregulating IgA1, to Japanese patients. The agreement, worth up
to $100M in upfront and milestone
payments, combines Calliditas' specifically formulated drug
candidate with Viatris' development, marketing and sales
expertise.
STOCKHOLM, Dec. 13,
2022 /PRNewswire/ -- Calliditas Therapeutics
AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas")
announced today that they have entered into an exclusive license
agreement with Viatris Pharmaceuticals Japan Inc., a subsidiary of
Viatris Inc. (NASDAQ: VTRS) ("Viatris"), to register and
commercialize Nefecon, a specialty drug recently approved in
Europe and the US for the
treatment of the chronic autoimmune kidney disease Immunoglobulin A
Nephropathy (IgAN) in Japan.
Under the terms of the agreement, Calliditas is entitled receive
an initial upfront payment of US$20M
upon signing and up to an additional US$80M in pre-defined development and
commercialization milestones. Viatris will also pay mid-teens
percentage royalties on net sales.
IgAN, also known as Berger's disease, is a rare and serious
progressive autoimmune disease in which up to 50% of patients end
up at risk of developing end stage renal disease and thus requiring
dialysis or a kidney transplant.
"We are excited to be entering into this license agreement with
Viatris, through its Global Healthcare Gateway®, to
bring this IgAN therapy to patients in Japan, where there is a significant unmet
medical need. We look forward to working in close collaboration to
pursue a Japanese marketing authorization with the goal of bringing
the first ever medication designed specifically to target the
origin of the disease to Japanese IgAN patients as soon as
possible," said Renée Aguiar-Lucander, CEO of Calliditas.
Locust Walk acted as transaction advisor to Calliditas.
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The information in the press release is information that
Calliditas is obliged to make public pursuant to the EU Market
Abuse Regulation. The information was sent for publication, through
the agency of the Calliditas contact person set out above, on
December 13, 2022 at 8:00 a.m. CET.
About Calliditas
Calliditas Therapeutics is a commercial stage biopharma company
based in Stockholm, Sweden focused
on identifying, developing and commercializing novel treatments in
orphan indications, with an initial focus on renal and hepatic
diseases with significant unmet medical needs. Calliditas' lead
product, Nefecon, has been granted accelerated approval by the FDA
under the trade name TARPEYO® and conditional
marketing authorization by the European Commission under the trade
name Kinpeygo®. Kinpeygo is being commercialized in
the European Union Member States by Calliditas' partner,
STADA Arzneimittel AG. Additionally, Calliditas is
conducting a Phase 2b/3 clinical
trial in primary biliary cholangitis and a Phase 2 proof-of-concept
trial in head and neck cancer with its NOX inhibitor product
candidate, setanaxib. Calliditas' common shares are listed on
Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares
are listed on the Nasdaq Global Select Market (ticker: CALT). Visit
www.calliditas.com for further information.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding Calliditas' strategy, business plans, regulatory
submissions and focus, as well as Calliditas' license agreement
with Viatris, the parties' plans with respect to registration and
commercialization of the specialty therapy, the terms of the
collaboration and the intended benefits therefrom, the regulatory
pathway and interactions for Nefecon, including the pursuit of
Japanese marketing authorization and timing thereof. The words
"may," "will," "could," "would," "should," "expect," "plan,"
"anticipate," "intend," "believe," "estimate," "predict,"
"project," "potential," "continue," "target" and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, any related to Calliditas' business, operations, the
conduct of Calliditas' license agreement with Viatris, the
potential for regulatory acceptance and the success and timeline of
its regulatory marketing application in Japan, clinical trials, supply chain,
strategy, goals and anticipated timelines, competition from other
pharmaceutical companies, and other risks identified in the section
entitled "Risk Factors" in Calliditas' reports filed with the
Securities and Exchange Commission. Calliditas cautions you not to
place undue reliance on any forward-looking statements, which speak
only as of the date they are made. Calliditas disclaims any
obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements. Any
forward-looking statements contained in this press release
represent Calliditas' views only as of the date hereof and should
not be relied upon as representing its views as of any subsequent
date.
The following files are available for download:
https://mb.cision.com/Main/16574/3683473/1731211.pdf
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Calliditas Therapeutics
announces license agreement with Viatris
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SOURCE Calliditas Therapeutics