FDA grants Calliditas Therapeutics Accelerated Approval of TARPEYO (budesonide) to Reduce Proteinuria in IgA Nephropathy TARPEYO (budesonide) delayed release capsules is the first and only treatment indicated to reduce p

grants Calliditas Therapeutics Accelerated Approval of TARPEYO (budesonide)

Reduce Proteinuria in IgA Nephropathy

Stockholm, December 15,

2021 - Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the

US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules 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. This indication is approved under accelerated approval. It has not been established whether TARPEYO slows kidney function

decline in patients with IgAN. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory

This approval marks the

successful transition for Calliditas to a commercial-stage biopharmaceutical company.

"We are very excited

to bring the first and only FDA-approved treatment to reduce proteinuria in IgAN to market," said Ren e Aguiar-Lucander,

Chief Executive Officer of Calliditas. "TARPEYO represents an FDA approved product to help these patients who are at risk of rapid

disease progression."

TARPEYO is approved under

accelerated approval based on achieving its primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study,

an ongoing, randomized, double-blind, placebo-controlled, multicenter study conducted to evaluate the efficacy and safety of TARPEYO

16 mg once daily vs placebo in adult patients with primary IgAN.1 The effect of TARPEYO was assessed in patients with biopsy-proven

IgAN, eGFR 35 mL/min/1.73 m2, and proteinuria (defined as either 1 g/day or UPCR 0.8 g/g) who were on

a stable dose of maximally-tolerated RAS inhibitor therapy.

Patients taking TARPEYO

(n=97) showed a statistically significant 34% reduction in proteinuria from baseline vs 5% with RASi alone (n=102) at 9 months. The treatment

effects for the primary endpoint of UPCR at 9 months were consistent across key subgroups, including key demographic and baseline disease

The most common adverse

reactions ( 5%) in this study were hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increase, dyspnea, face

edema, dyspepsia, fatigue, and hirsutism. Please see additional Important Safety Information below.

Richard Lafayette M.D., Professor of

Medicine at Stanford University and the Director of the Stanford Glomerular Disease Center commented, "IgAN is a tough diagnosis

for many patients, and it can progressively lead to the need for dialysis and/or kidney transplantation. The FDA approval of TARPEYO

now offers disease-specific treatment for patients with this complicated disease."

Richard Philipson, Calliditas

Chief Medical Officer added, "TARPEYO was developed to target a root cause of IgAN. The FDA's approval of TARPEYO demonstrates

our unwavering dedication to patients suffering from IgAN. We would like to thank the patients, researchers and clinical staff who participated

in the studies of TARPEYO."

Bonnie Schneider, Director

and Co-Founder of the IGA Nephropathy Foundation of America commented," It has been a difficult journey not only for our family

but for all the IgA nephropathy patients we serve. Having this disease specific option has our community very excited."

It is expected that TARPEYO

will be available in the U.S. early in the first quarter of 2022. To assist patients and their healthcare providers who would prescribe

TARPEYO, Calliditas is launching a comprehensive patient support program, TARPEYO Touchpoints . This program offers services, assistance,

and resources designed to help patients access treatment as easily as possible. To learn more visit TARPEYOTouchpoints.com or call 1-833-444-8277.

For access to additional

materials related to this announcement, click here to locate the media kit.

Investor presentation

December 16, 8:00 ET / 14:00 CET

Calliditas will host an

audio cast with teleconference, with presentations from CEO Ren e Aguiar-Lucander and Andrew Udell, President of North America,

December 16, 8:00 ET / 14:00 CET.

Webcast: https://tv.streamfabriken.com/press-conference-audiocast-december-2021

Teleconference: SE: +46

856642651 PIN: 44920298# | UK: +44 3333000804 PIN: 44920298# | US: +1 6319131422 PIN: 44920298#

INDICATION and IMPORTANT

TARPEYO (budesonide)

delayed release capsules is a corticosteroid 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) 1.5 g/g.

This indication is approved

under accelerated approval based on a reduction in proteinuria. It has not been established whether TARPEYO slows kidney function decline

in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit

in a confirmatory clinical trial.

Important Safety Information

Contraindications: TARPEYO

is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions,

including anaphylaxis, have occurred with other budesonide formulations.

Warnings and Precautions

Hypercorticism and adrenal axis

suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may

occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where

patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When

discontinuing therapy [see Dosing and Administration] or switching between corticosteroids, monitor for signs of adrenal axis

Patients with moderate to

severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression

due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C).

Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).

Risks of Immunosuppression:

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox

and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses

of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial,

systemic viral, or parasitic infections; or ocular herpes simplex. Avoid exposure to active, easily transmitted infections (eg, chicken

pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.

Other corticosteroid

effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients

with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, a family history of diabetes or glaucoma,

or with any other condition in which corticosteroids may have unwanted effects.

Adverse reactions: In

clinical studies, the most common adverse reactions with TARPEYO (occurring in 5% of TARPEYO patients and 2% higher

than placebo) were hypertension (16%), peripheral edema (14%), muscle spasms (13%), acne (11%), dermatitis (7%), weight increase

(7%), dyspnea (6%), face edema (6%), dyspepsia (5%), fatigue (5%), and hirsutism (5%).

Drug interactions: Budesonide

is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir,

erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity,

can increase the systemic exposure to budesonide.

Use in specific populations

Pregnancy: The available

data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified

a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother

and fetus associated with IgAN. Infants exposed to in utero corticosteroids, including budesonide, are at risk for hypoadrenalism.

Please see Full Prescribing

Information for TARPEYO here.

Calliditas has introduced