Asahi Kasei bündelt globales Pharmageschäft unter der Marke Asahi Kasei Therapeutics
TOKYO – 30. September 2026 – Asahi Kasei hat bekannt gegeben, dass Asahi Kasei Therapeutics in Japan, Veloxis Pharmaceuticals in den USA, Calliditas Therapeutics in Schweden sowie das kürzlich erworbene deutsche Unternehmen AiCuris Anti-infective Cures künftig unter der gemeinsamen Marke Asahi Kasei Therapeutics zusammengeführt werden. Mit dieser Integration schafft das Unternehmen eine einheitliche globale Managementstruktur für sein Pharmageschäft. Die Maßnahme markiert einen wichtigen Schritt auf dem Weg zum strategischen Ziel, bis zum Geschäftsjahr 2030 ein weltweit führendes Specialty-Pharma-Unternehmen mit einem Umsatz von 300 Milliarden Yen aufzubauen.
Die Zusammenführung erfolgt vor dem Hintergrund der internationalen Expansion von Asahi Kaseis Pharmageschäft, das mit den genannten strategischen Aufkäufen in den letzten Jahren seine Präsenz in den westlichen Märkten deutlich ausgebaut hat. Die Pharmastrategie des Konzerns konzentriert sich auf spezialisierte Therapiegebiete mit hohem medizinischem Bedarf. Schwerpunkte liegen insbesondere in den Bereichen Immunologie, Nephrologie, Transplantationsmedizin und Infektionskrankheiten. Dieser Ansatz ermöglicht nachhaltige Investitionen in Forschung und Entwicklung.
„Die Zusammenführung unserer Pharmageschäfte unter einer gemeinsamen globalen Managementstruktur ermöglicht es uns, Ressourcen künftig unternehmensweit statt nach einzelnen Gesellschaften oder Regionen zu steuern“, erklärt Yoshikazu Aoki, Global President von Asahi Kasei Therapeutics. „Gleichzeitig stärkt sie unsere Position bei der Einlizenzierung innovativer Wirkstoffe und Technologien, mit denen wir unsere Entwicklungspipeline weiter ausbauen und langfristiges Wachstum fördern können. Auf Grundlage einer gemeinsamen Mission, Vision und gemeinsamer Werte werden wir als globales Team daran arbeiten, Patienten weltweit innovative Therapien und neue Behandlungsmöglichkeiten bereitzustellen.“
Mit der Übernahme von Veloxis im Jahr 2020 etablierte das Unternehmen eine kommerzielle Präsenz in den USA mit Schwerpunkt auf der Nierentransplantation. Die Akquisition von Calliditas im Jahr 2024 erweiterte das Portfolio um Therapien für Nierenerkrankungen und stärkte die Vermarktungskompetenzen in den USA und die Entwicklung in Europa. Durch die Übernahme von AiCuris im Jahr 2026 wurde die Pipeline um innovative Ansätze im Bereich Infektionskrankheiten erweitert und die Entwicklungsfähigkeiten in Europa weiter ausgebaut.
Das kombinierte Portfolio bildet eine solide Grundlage für weiteres Wachstum. Die US-Umsätze von ENVARSUS XR (Tacrolimus-Retardtabletten) verzeichneten seit der Übernahme von Veloxis im Jahr 2020 eine durchschnittliche jährliche Wachstumsrate im hohen zweistelligen Bereich. Für TARPEYO (Budesonid-Kapseln mit verzögerter Freisetzung) liegt die Erwartung zur Umsatzentwicklung weiterhin über den Prognosen zur Zeit der Übernahme von Calliditas 2024. Das Portfolio von AiCuris bietet zusätzliche Wachstumsperspektiven durch kontinuierliche Lizenzerträge aus Prevymis (Letermovir) sowie durch potenzielle zukünftige Beiträge aus der eigenen Entwicklungspipeline.
„Diese vier Unternehmen vereinen jahrzehntelange wissenschaftliche Innovationskraft, hochspezialisiertes Know-how und ein gemeinsames Engagement für die Bedürfnisse von Patienten“, sagt Stacy Wheeler, Chief Executive Officer von Asahi Kasei Therapeutics für die USA und Europa. „Die Erfahrung dieser Teams, kombiniert mit den wissenschaftlichen Kompetenzen von Asahi Kasei und einer starken wirtschaftlichen Basis, schafft hervorragende Voraussetzungen, um unser bestehendes Portfolio weiterzuentwickeln, Pipeline-Projekte voranzutreiben und neue Chancen in therapeutischen Spezialgebieten mit hohem ungedecktem medizinischem Bedarf zu erschließen.“
Im Rahmen seines mittelfristigen Managementplans plant Asahi Kasei in den kommenden drei Jahren Investitionen von rund 40 Milliarden Yen in Einlizenzierungsprojekte. Ergänzt wird dies durch kontinuierliche Investitionen in das bestehende Produktportfolio sowie in die Entwicklungs-Pipeline.
Nach der Übernahme von AiCuris baut Asahi Kasei sein Pharmageschäft weiter aus und verfolgt konsequent das Ziel, bis zum Geschäftsjahr 2030 einen Umsatz von 300 Milliarden Yen zu erzielen. Das angestrebte Wachstum soll sowohl durch bestehende Produkte und Pipeline-Kandidaten als auch durch weitere Akquisitionen und Einlizenzierungen neuer Wirkstoffe unterstützt werden.
Weitere Informationen zu Asahi Kasei Therapeutics finden Sie unter: https://www.aktx.com.
IMPORTANT SAFETY INFORMATION FOR US AUDIENCE
INDICATIONS AND USAGE
ENVARSUS XR is indicated for the prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants. ENVARSUS XR is also indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppres-sants.
IMPORTANT SAFETY INFORMATION WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death
CONTRAINDICATIONS
ENVARSUS XR is contraindicated in patients with known hypersensitivity to tacrolimus or to any of the ingredients in ENVARSUS XR.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including ENVARSUS XR, increase the risk of developing lymphomas and other malignancies, particularly of the skin. Post-transplant lymphoproliferative disorder (PTLD), associated with Epstein-Barr Virus (EBV), has been reported in immunosuppressed organ transplant patients.
Serious Infections:
Immunosuppressants, including ENVARSUS XR, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes.
Not Interchangeable with Other Tacrolimus Products – Medication Errors:
Medication errors, including substitution and dispensing errors, between tacrolimus capsules and tacrolimus extended-release capsules were reported outside the U.S. in some cases leading to adverse reactions. ENVARSUS XR is not interchangeable or substitutable with tacrolimus extended-release capsules, tac-rolimus capsules or tacrolimus for oral suspension.
New Onset Diabetes after Transplant:
ENVARSUS XR caused new onset diabetes after transplant (NODAT) in kidney transplant patients, which may be reversible in some patients. African-American and Hispanic kidney transplant patients are at an increased risk.
Nephrotoxicity due to ENVARSUS XR and Drug Interactions:
ENVARSUS XR, like other cal-cineurin-inhibitors, can cause acute or chronic nephrotoxicity. In patients with elevated serum creati-nine and tacrolimus whole blood trough concentrations greater than the recommended range, con-sider dosage reduction or temporary interruption of tacrolimus administration. The risk for nephrotoxicity may increase when ENVARSUS XR is concomitantly administered with CYP3A inhibitors (by in-creasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity. When tacrolimus is used concurrently with CYP3A inhibitors or other known nephrotoxic drugs, monitor renal function and tacrolimus blood concentrations, and adjust dose of both tacrolimus and/or concomitant medications during concurrent use.
Neurotoxicity:
ENVARSUS XR may cause a spectrum of neurotoxicities. The most severe neurotox-icities include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremors, paresthesias, headache, mental status changes, and changes in motor and sensory functions.
Hyperkalemia:
Mild to severe hyperkalemia, which may require treatment, has been reported with tacrolimus including ENVARSUS XR. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.
Hypertension: Hypertension is a common adverse reaction to ENVARSUS XR therapy and may re-quire antihypertensive therapy.
Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors:
The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. In contrast, the concomitant use of strong CYP3A inhibitors may decrease the metabolism of tacrolimus, leading to higher whole blood trough concentrations and greater risk of serious adverse reactions. Therefore, adjust ENVARSUS XR dose and monitor tacrolimus whole blood trough concentrations when co-administering ENVARSUS XR with strong CYP3A inhibitors or strong CYP3A inducers. A rapid, sharp rise in tacrolimus levels has been reported after co-administration with strong CYP3A4 inhibitors despite an initial reduction of tacrolimus dose. Early and frequent monitoring of tacrolimus whole blood trough levels is recommended.
QT Prolongation:
ENVARSUS XR may prolong the QT/QTc interval and cause Torsade de pointes. Avoid ENVARSUS XR in patients with congenital long QT syndrome. Consider obtaining electrocardiograms and monitoring electrolytes periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances. When co-administering ENVARSUS XR with other substrates and/or inhibitors of CYP3A, especially those that also have the potential to prolong the QT interval, a reduction in ENVARSUS XR dosage, monitoring of tacrolimus whole blood concentrations, and monitoring for QT prolongation is recommended.
Immunizations:
Whenever possible, administer the complete complement of vaccines before trans-plantation and treatment with ENVARSUS XR. Avoid the use of live attenuated vaccines during treat-ment with ENVARSUS XR. Inactivated vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic during treatment with ENVARSUS XR.
Pure Red Cell Aplasia:
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus. If PRCA is diagnosed, consider discontinuation of ENVARSUS XR.
Cannabidiol Drug Interactions:
When cannabidiol and ENVARSUS XR are co-administered, closely monitor for an increase in tacrolimus blood levels and for adverse reactions suggestive of tacrolimus toxicity. A dose reduction of ENVARSUS XR should be considered as needed when ENVAR-SUS XR is co-administered with cannabidiol.
Thrombotic Microangiopathy (TMA) Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura:
Cases of thrombotic microangiopathy (TMA), including hemolytic uremic syndrome (HUS) and thrombotic thrombocytopenic purpura (TTP), have been reported in patients treated with ENVARSUS XR. Transplant patients may have other risk factors which contribute to the risk of TMA. In patients with signs and symptoms of TMA, consider ENVARSUS XR as a risk factor. Concurrent use of ENVARSUS XR and mammalian target of rapamycin (mTOR) inhibitors may contribute to the risk of TMA.
ADVERSE REACTIONS
De Novo kidney transplant patients:
Most common adverse reactions (incidence ≥15%) reported with ENVARSUS XR are diarrhea, anemia, urinary tract infection, hypertension, tremor, constipation, diabetes mellitus, peripheral edema, hyperkalemia and headache. Conversion of kidney transplant patients from immediate-release tacrolimus: Most common adverse reactions (incidence ≥10%) reported with ENVARSUS XR include: diarrhea and blood creatinine increased.
USE IN SPECIFIC POPULATIONS
Pregnancy:
Based on postmarketing surveillance, registry and animal data may cause fetal harm. Advise pregnant women of the potential risk to the fetus.
Nursing Mothers: Tacrolimus is present in human milk. Discontinue drug or nursing, taking into account the importance of drug to the mother.
Females and Males of Reproductive Potential:
Advise female and male patients of reproductive potential to speak with their healthcare provider on family planning options including appropriate contraception prior to starting treatment with ENVARSUS XR. Based on animal studies, ENVARSUS XR may affect fertility in males and females.
Pediatric Use:
The safety and efficacy of ENVARSUS XR in pediatric patients have not been established.
Geriatric Use:
Clinical studies of ENVARSUS XR did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Renal Impairment:
Frequent monitoring of renal function is recommended. Lower doses may be required.
Hepatic Impairment: Frequent monitoring of tacrolimus trough concentrations is recommended. With greater tacrolimus whole blood trough concentrations in patients with severe hepatic impairment, there is a greater risk of adverse reactions and dosage reduction is recommended.
Race:
African-American patients may require higher doses to attain comparable trough concentra-tions compared to Caucasian patients. African-American and Hispanic kidney transplant patients are at an increased risk for new onset diabetes after transplant. Monitor blood glucose concentrations and treat appropriately.
To report SUSPECTED ADVERSE REACTIONS, contact Veloxis Pharmaceuticals, Inc. at 1-844-VELOXIS (835-6947) or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning.
INDICATION
TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
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 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 in-creased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impair-ment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).
Immunosuppression and Increased Risk of Infection:
Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed.
Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi’s sarcoma. Avoid exposure to active, easily-transmitted infections (e.g., chickenpox, 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 or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.
ADVERSE REACTIONS
In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%).
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 activ-ity, 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.
FORWARD-LOOKING STATEMENTS
Statements contained in this release regarding future plans, expectations, forecasts, projections, or business outlook are based on assumptions and information currently available to the Company. Such statements are subject to risks and uncertainties and should not be regarded as guarantees of future performance, financial results, or the achievement of any plans, initiatives, or objectives.
US-AKTX-2600070
Über Asahi Kasei
Die Asahi Kasei Gruppe trägt zum Leben und zur Lebensqualität von Menschen auf der ganzen Welt bei. Seit seiner Gründung im Jahr 1922 mit dem Geschäft mit Ammoniak und Zellulosefasern ist Asahi Kasei durch die proaktive Umgestaltung seines Geschäftsportfolios kontinuierlich gewachsen, um den sich wandelnden Bedürfnissen jeder Zeit gerecht zu werden. Mit 50.000 Mitarbeitern weltweit trägt das Unternehmen zu einer nachhaltigen Gesellschaft bei, indem es in seinen drei Geschäftsbereichen Healthcare, Homes und Material Lösungen für die Herausforderungen der Welt anbietet. Weitere Informationen finden Sie unter www.asahi-kasei.com.
Kontakt:
Asahi Kasei Europe GmbH
Sebastian Schmidt
sebastian.schmidt@asahi-kasei.eu