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    CALTX   SE0010441584

CALLIDITAS THERAPEUTICS AB (PUBL)

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Biologics by McKesson - TARPEYOTM (budesonide) delayed release capsules, FDA Approved to Reduce Proteinuria in IgA Nephropathy, Available Exclusively at Biologics by McKesson

12/23/2021 | 09:21am EDT

CARY, N.C. - Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, was selected by Calliditas Therapeutics as the exclusive specialty pharmacy provider for TARPEYOTM (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

TARPEYO, approved by the U.S. Food and Drug Administration (FDA) on December 15, 2021, is the first and only FDA-approved treatment that was specifically designed for this condition. IgAN is a rare, progressive autoimmune disease, which has a high unmet need with more than 50% of patients potentially progressing to end-stage renal disease. 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.

With its innovative PharmacyElite program, Biologics will help patients start on TARPEYO quickly by managing access, reimbursement and clinical services with a high degree of efficiency. This integrated approach marries Biologics' industry-leading, high-touch specialty pharmacy solution with specific patient access and support services critical to support TARPEYO patients and providers. PharmacyElite is powered by a dedicated team focused on removing common points of redundancy and improving outcomes throughout the TARPEYO patient journey.

'TARPEYO may help address an unmet need for patients with primary IgA nephropathy who currently lack a treatment option designed to target their disease,' said Ela Lourido, vice president of Biopharma Services at Biologics. 'It's an honor for us to be chosen by Calliditas as the sole distributor for this essential therapy.'

'The approval of TARPEYO represents a unique opportunity to bring a disease-specific treatment to patients in need,' said Andrew Udell, president, North America at Calliditas Therapeutics. 'We are proud to be launching TARPEYO with a full-service TARPEYO TouchpointsTM patient support program, designed to offer services, assistance and resources to help patients access treatment as quickly as possible.'

Biologics specialty pharmacy is committed to and recognized for its level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes pharmacists with in-depth knowledge of therapies, experienced nurses and financial counselors who are familiar with various financial assistance programs and organizations that help patients. This deeply skilled care team works together to develop individualized care plans that address each patient's unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

Indication

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 suppression.

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 (e.g., 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.

About Biologics by McKesson

Biologics by McKesson is an independent specialty pharmacy with more than 25 years of experience connecting patients to life-changing medications in oncology and other rare and complex therapeutic areas. Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics delivers seamless access and personalized engagement, so patients get the most out of the care they receive. As a business within McKesson Corporation, Biologics harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers and biopharma, so together, they can deliver better care and outcomes for every patient.

Contact:

Claire Crye

Public Relations

T: 281-825-9927

E: Claire.Crye@McKesson.com

(C) 2021 Electronic News Publishing, source ENP Newswire

Stocks mentioned in the article
ChangeLast1st jan.
CALLIDITAS THERAPEUTICS AB (PUBL) 7.49% 79.6 Delayed Quote.-34.35%
MCKESSON CORPORATION -3.75% 320.65 Delayed Quote.34.03%
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Sales 2022 531 M 53,0 M 53,0 M
Net income 2022 -601 M -60,1 M -60,1 M
Net cash 2022 6,81 M 0,68 M 0,68 M
P/E ratio 2022 -7,44x
Yield 2022 -
Capitalization 4 233 M 423 M 423 M
EV / Sales 2022 7,96x
EV / Sales 2023 2,19x
Nbr of Employees 86
Free-Float 82,0%
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Renée Julie Elisabet Aguiar-Lucander Chief Executive Officer
Fredrik Johansson Chief Financial Officer
Elmar J. Schnee Chairman
Johan Erik Häggblad Chief Scientific Officer
Richard Philipson Chief Medical Officer
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