On February 24, 2022 Calliditas Therapeutics reported that Year-End Report, 2021 (Press release, Calliditas Therapeutics, FEB 24, 2022, View Source [SID1234608923])
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"The accelerated approval of TARPEYO was for the indication of reduction of proteinuria, which was the endpoint of Part A of the trial, in adult patients with IgA nephropathy with risk of rapid progression, which is characterized as generally UPCR ≥ 1.5 g/g. It is well established that patients with higher levels of proteinuria have a worse outlook and prognosis as they tend to experience a more rapid decline of their kidney function, as measured by eGFR. These patients are therefore at considerable risk of progressing to ESRD, resulting in the need for dialysis or transplantation. We are obviously thrilled to be able to bring a medication to all these patients, who before now did not have any approved treatment options that addressed their illness.
This undertaking has taken well over a decade to reach patients and is the result of the incredibly hard work and dedication of a diverse and extraordinary group of people, working as a team towards a common goal. It has been a privilege to help guide and participate in this amazing journey over the last 4 years, and I am confident that this is just the beginning of our evolution into a broad-based biopharma business with the requisite talent, resources and science to continue to deliver enduring value to all of our stakeholders."
Renée Aguiar-Lucander, CEO
Summary of Q4 2021
October 1 – December 31, 2021
Net sales amounted to SEK 31.2 million and SEK 0.4 million for the three months ended December 31, 2021 and 2020, respectively.
Operating loss amounted to SEK 222.1 million and SEK 135.9 million for the three months ended December 31, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 4.19 and SEK 3.41 for the three months ended December 31, 2021 and 2020, respectively.
Cash amounted to SEK 955.5 million and SEK 996.3 million as of December 31, 2021 and 2020, respectively.
Significant events during Q4 2021, in summary
In December 2021, Calliditas announced that the US Food and Drug Administration (FDA) had granted accelerated approval for TARPEYO (budesonide) delayed release capsules indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. TARPEYO is the first and only FDA-approved treatment for this disease and was designed specifically to target the origin of IgA nephropathy. This approval marked the successful transition for Calliditas to a commercial-stage biopharmaceutical company.