Calliditas Therapeutics announces license agreement with Viatris to register and commercialize specialty therapy for IgA nephropathy in Japan

By writer to news.google.com

Calliditas declares that it has entered into an settlement with Viatris to deliver Nefecon®, a specialty remedy centered on downregulating IgA1, to Japanese sufferers. The settlement, value as much as $100M in upfront and milestone funds, combines Calliditas’ particularly formulated drug candidate with Viatris’ improvement, advertising and gross sales experience.

STOCKHOLM, Dec. 13, 2022 /PRNewswire/ — Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) (“Calliditas”) introduced in the present day that they’ve entered into an unique license settlement with Viatris Prescribed drugs Japan Inc., a subsidiary of Viatris Inc. (NASDAQ: VTRS) (“Viatris”), to register and commercialize Nefecon, a specialty drug lately accepted in Europe and the US for the remedy of the persistent autoimmune kidney illness Immunoglobulin A Nephropathy (IgAN) in Japan.

Below the phrases of the settlement, Calliditas is entitled obtain an preliminary upfront fee of US$20M upon signing and as much as an extra US$80M in pre-defined improvement and commercialization milestones. Viatris may also pay mid-teens share royalties on web gross sales.

IgAN, also called Berger’s illness, is a uncommon and severe progressive autoimmune illness during which as much as 50% of sufferers find yourself susceptible to growing finish stage renal illness and thus requiring dialysis or a kidney transplant.

“We’re excited to be coming into into this license settlement with Viatris, by means of its International Healthcare Gateway^®, to deliver this IgAN remedy to sufferers in Japan, the place there’s a important unmet medical want. We stay up for working in shut collaboration to pursue a Japanese advertising authorization with the purpose of bringing the primary ever medicine designed particularly to focus on the origin of the illness to Japanese IgAN sufferers as quickly as doable,” mentioned Renée Aguiar-Lucander, CEO of Calliditas.

Locust Stroll acted as transaction advisor to Calliditas.

For additional data, please contact:

Marie Galay, IR Supervisor, Calliditas
Tel: +44 79 55 12 98 45, e mail: marie.galay@calliditas.com

The data within the press launch is data that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The data was despatched for publication, by means of the company of the Calliditas contact individual set out above, on December 13, 2022 at 8:00 a.m. CET.

About Calliditas

Calliditas Therapeutics is a industrial stage biopharma firm based mostly in Stockholm, Sweden centered on figuring out, growing and commercializing novel therapies in orphan indications, with an preliminary concentrate on renal and hepatic ailments with important unmet medical wants. Calliditas’ lead product, Nefecon, has been granted accelerated approval by the FDA below the commerce identify TARPEYO^® and conditional advertising authorization by the European Fee below the commerce identify Kinpeygo^®. Kinpeygo is being commercialized within the European Union Member States by Calliditas’ companion, STADA Arzneimittel AG. Moreover, Calliditas is conducting a Part 2b/three medical trial in major biliary cholangitis and a Part 2 proof-of-concept trial in head and neck most cancers with its NOX inhibitor product candidate, setanaxib. Calliditas’ frequent shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq International Choose Market (ticker: CALT). Go to www.calliditas.com for additional data.

Ahead-Wanting Statements

This press launch accommodates forward-looking statements inside the that means of the Non-public Securities Litigation Reform Act of 1995, as amended, together with, with out limitation, statements relating to Calliditas’ technique, enterprise plans, regulatory submissions and focus, in addition to Calliditas’ license settlement with Viatris, the events’ plans with respect to registration and commercialization of the specialty remedy, the phrases of the collaboration and the supposed advantages therefrom, the regulatory pathway and interactions for Nefecon, together with the pursuit of Japanese advertising authorization and timing thereof. The phrases “could,” “will,” “might,” “would,” “ought to,” “anticipate,” “plan,” “anticipate,” “intend,” “consider,” “estimate,” “predict,” “challenge,” “potential,” “proceed,” “goal” and related expressions are supposed to determine forward-looking statements, though not all forward-looking statements include these figuring out phrases. Any forward-looking statements on this press launch are based mostly on administration’s present expectations and beliefs and are topic to a variety of dangers, uncertainties and vital elements that will trigger precise occasions or outcomes to vary materially from these expressed or implied by any forward-looking statements contained on this press launch, together with, with out limitation, any associated to Calliditas’ enterprise, operations, the conduct of Calliditas’ license settlement with Viatris, the potential for regulatory acceptance and the success and timeline of its regulatory advertising utility in Japan, medical trials, provide chain, technique, targets and anticipated timelines, competitors from different pharmaceutical firms, and different dangers recognized within the part entitled “Threat Elements” in Calliditas’ studies filed with the Securities and Alternate Fee. Calliditas cautions you to not place undue reliance on any forward-looking statements, which converse solely as of the date they’re made. Calliditas disclaims any obligation to publicly replace or revise any such statements to mirror any change in expectations or in occasions, situations or circumstances on which any such statements could also be based mostly, or that will have an effect on the probability that precise outcomes will differ from these set forth within the forward-looking statements. Any forward-looking statements contained on this press launch signify Calliditas’ views solely as of the date hereof and shouldn’t be relied upon as representing its views as of any subsequent date.

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