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: December 11, 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 December 11, 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.
|
CALLIDITAS THERAPEUTICS AB |
|
|
|
Date: December 11, 2023 |
By: |
/s/ Fredrik Johansson |
|
|
Fredrik Johansson |
|
|
Chief Financial Officer |
Exhibit 99.1
Stockholm, Sweden |
December 11, 2023 |
Calliditas Receives Notice of Allowance for United States
Patent Application Covering TARPEYO®
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq
Stockholm: CALTX) (“Calliditas”) today announced that it has received a Notice of Allowance from the United States Patent
and Trademark Office (USPTO) for patent application no. 18/100,396 entitled “New Pharmaceutical Compositions.” This Notice
of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
The allowed claims cover a method of treating IgA nephropathy
with a composition that encompasses TARPEYO® (budesonide) delayed release capsules, developed under the name “NEFECON®”.
Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043. The patent, when issued,
will be Calliditas’ second patent for TARPEYO in the United States.
Calliditas intends to file corresponding patent applications
in additional territories around the world, including Europe and China.
“When issued, our new patent will significantly
strengthen TARPEYO’s intellectual property protection, further improving its unique value proposition, and providing a basis for
an active program of extending patent protection of the NEFECON® franchise globally,” said CEO Renée Aguiar-Lucander.
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 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 contact persons set out above, on December 11, 2023 at 15:15 p.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 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. NEFECON has also been
approved by China’s National Medical Products Administration and is being commercialized in China and other Asian countries by
Everest Medicines (HKEX: 1952.HK).
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’ strategy, the scope and strength of the company’s intellectual property estate, the
issuance of new patents and anticipated expiration date thereof, the listing of additional patents in the Orange Book, business
plans, regulatory submissions, and focus. 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, intellectual
property of the NEFECON franchise globally, continued regulatory approvals for TARPEYO, competition from other companies, revenue
and product sales projections or forecasts, 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.
Calliditas Therapeutics AB (PK) (USOTC:CLTEF)
Historical Stock Chart
From Jun 2024 to Jul 2024
Calliditas Therapeutics AB (PK) (USOTC:CLTEF)
Historical Stock Chart
From Jul 2023 to Jul 2024