Our Expertise Helps Patients in Need

On December 20, 2023, the United States (US) Food and Drug Administration (FDA) granted Calliditas full approval of TARPEYO^® (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

STRENGTHENING TARPEYO’S IP

The United States Patent and Trademark Office (USPTO) provided Notice of Allowance for patent application no. 18/100,396 entitled “New Pharmaceutical Compositions.”.

PARTNERSHIPS’ MILESTONES ACHIEVED

Commercial partner, Everest Medicines, received approval from China’s National Medical Products Administration (NMPA) of Nefecon^® for the treatment of primary IgAN iIn adults at risk of disease progression.

Everest Medicines received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China.

Commercial partner, STADA Arzneimittel AG, submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization (CMA) for Kinpeygo^® to standard, or “full”, marketing authorization.

The MHRA of the United Kingdom granted CMA for Kinpeygo for the treatment of IgAN in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.

STADA request to the EMA to convert conditional marketing authorization to standard marketing authorization for Kinpeygo treatment for primary IgAN.

ADVANCING SCIENCE AND OTHER NEWS

The Lancet published the full data from the Phase 3 NefIgArd study.

The FDA accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO and granted Priority Review.

Positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd were announced.

PROMISE OF NOX INHIBITORS RECOGNIZED

EMA Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome

US FDA  granted orphan drug designation (ODD) to setanaxib for the treatment of Alport syndrome

Interim data from the proof-of-concept Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with setanaxib was announced. The analysis reflected encouraging early clinical progression-free survival (PFS) results and supports the presumed anti fibrotic mode of action of setanaxib.

Calliditas announced supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib. The analysis reflected encouraging early clinical progression-free survival (PFS) results and supports the presumed anti fibrotic mode of action of setanaxib.

Deleted: On December 15, 2021, the FDA granted Calliditas accelerated approval of TARPEYO to reduce proteinuria in patients with IgA nephropathy. TARPEYO became the first and only approved treatment for this indication

Submitted a New Drug Application to the United States (US) FDA and a Marketing Authorization Application to the European Medicines Agency for patients with primary IgA nephropathy

Announced full enrollment of the Phase 3 NeflgArd trial

EUROPEAN COMMERCIAL PARTNERSHIP

Partnered with STADA Arzneimittel AG to register and commercialize a specialty therapy for IgA Nephropathy in Europe

GENKYOTEX ACQUISITION

Completed acquisition of Genkyotex, which became a wholly owned subsidiary of Calliditas and was delisted from the Euronext stock exchanges

SECURING FINANCING

Resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of approximately SEK 324 million

Secured a USD 75 million term loan facility from Kreos Capital

Calliditas and Everest Medicines entered into a licensing agreement to develop and commercialize Calliditas’ leading product candidate in Greater China and Singapore

ADVANCING THE PIPELINE

Finished recruitment for the pivotal Phase 3 clinical trial NeflgArd Part A
Exclusively in-licensed Budenofalk 3 mg oral capsules for the US market from the German pharmaceutical company. Dr. Falk Pharma GmbH

CALLIDITAS ESTABLISHED A US PRESENCE

Appointment of VP Commercial, North America

Pharmalink is renamed Calliditas Therapeutics

ADVANCING CLINICAL TRIALS

Positive results of Phase 2b Clinical Trial of Nefecon in Primary IgA Nephropathy published in The Lancet

Use of proteinuria as a surrogate marker and design of Phase 3 study accepted by the FDA

Invited to work with the Kidney Health Initiative (American Society of Nephrology) to identify surrogate endpoints in IgA Nephropathy

ADVANCING CLINICAL PROGRAM

Announced positive initial results from Phase 2B NEFIGAN trial, which met its primary endpoint in a planned interim analysis