Full Press Release Details
Calliditas Therapeutics
announces license agreement with Viatris to register and commercialize specialty therapy for IgA nephropathy in Japan
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.
December 13, 2022 - 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.
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.
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.
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 Ren e Aguiar-Lucander, CEO of Calliditas.
as transaction advisor to Calliditas.
information, please contact:
12 98 45, email: marie.galay@calliditas.com
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.
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
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.