UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: November 24, 2023
(Commission File No. 001-39308)
CALLIDITAS THERAPEUTICS AB
(Translation of registrant’s name into
English)
Kungsbron 1, D5
SE-111 22
Stockholm, Sweden
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F x
Form 40-F ¨
INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
Enclosed hereto is a copy of an announcement published by Calliditas
Therapeutics AB on November 24, 2023.
The information contained in this Form 6-K, including Exhibit 99.1,
is hereby incorporated by reference into the registrant’s Registration Statements on Form F-3 (File No. 333-265881) and Form S-8
(File Nos. 333-240126 and 333-272594).
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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CALLIDITAS THERAPEUTICS AB |
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Date: November 24, 2023 |
By: |
/s/ Fredrik Johansson |
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Fredrik Johansson |
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Chief Financial Officer |
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1795579/000110465923121013/tm2331509d1_ex99-2img001.jpg)
Stockholm, Sweden |
November 24, 2023 |
Calliditas’
partner Everest Medicines announces China NMPA’s approval of Nefecon® for the treatment of primary IgA nephropathy
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq
Stockholm: CALTX) (“Calliditas”) today announced that its partner Everest Medicines (HKEX: 1952.HK) ("Everest")
announced that China's National Medical Products Administration (NMPA) has approved Nefecon® for the treatment of primary immunoglobulin
A nephropathy (IgAN) in adults at risk of disease progression.
China has the highest prevalence
of primary glomerular diseases in the world with an estimated five million IgAN patients. There is a very significant unmet medical need
for novel therapies among IgAN patients in China and other Asian countries. Everest also announced that, in addition to Nefecon’s
approval in mainland China and Macau, it expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the
near term.
“We are very excited about
Nefecon’s approval in China. There is clearly a very significant need amongst IgAN patients in China to have access to an approved
medication specifically designed to target the origin of the disease and which provides hope of disease modification,” says CEO
Renée Aguiar-Lucander.
Results from the Chinese subpopulation
analysis of the Phase 3 NefIgArd trial, presented at the American Society of Nephrology (ASN) Kidney Week 2023, provided evidence that
the treatment effect of Nefecon in the Chinese cohort was greater than in the global data set with regards to kidney function, proteinuria
and microhematuria. In the Chinese cohort, the mean absolute change from baseline in eGFR at 24 months showed an approximately 66% reduction
in loss of this measure of kidney function with Nefecon compared with a 50% reduction in loss of eGFR in the global data set.
This approval triggers a milestone payment
of five million USD to Calliditas, which will be included as revenue in the fourth quarter.
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43,
Email: asa.hillsten@calliditas.com
The information was sent for publication, through the
agency of the contact person set out above, on November 24, 2023 at 08:45 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, developed under
the name Nefecon®, has been granted accelerated approval by the US FDA under the trade name TARPEYO® and conditional marketing
authorisation 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 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).
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’ or Everest’s strategy, commercialization efforts and potential, regulatory submissions and anticipated
timelines and outcomes, including anticipated timing of NDA approval in Singapore and Hong Kong. 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’ or Everest’s business, operations, continued and additional regulatory approvals, market acceptance
of products, goals and anticipated timelines, 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.
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