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Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

Regulatory

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.