STOCKHOLM, Jan. 7, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas'), a commercial biopharma company focused on rare diseases today announced that Maria Törnsén has been appointed to the position of President North America. Ms Törnsén will be responsible for all US based operations and will report to the CEO.

斯德哥尔摩，2024年1月7日/PRNewswire/--专注于罕见疾病的商业生物制药公司Calliditas Therapeutics AB（纳斯达克：CALT）（纳斯达克-斯德哥尔摩：CALTX）（“Calliditas”）今天宣布，Maria Törnsén已被任命为北美总统。特恩女士将负责所有美国运营，并向首席执行官汇报。

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Maria Törnsén has broad commercial leadership experience having spent more than 20 years in the biopharma industry in senior commercial roles. Most recently Ms Törnsén held the position of Chief Commercial Officer at Passage Bio, prior to which she was SVP General Manager US at Sarepta Therapeutics.

Maria Törnsen拥有丰富的商业领导经验，曾在生物制药行业担任高级商业职务20多年。最近，Törnsen女士在Passage Bio担任首席商务官，此前她是Sarepta Therapeutics的高级副总裁兼美国总经理。

Prior to joining Sarepta she served as VP Global Therapeutic Area Head at Sanofi Genzyme and held several senior commercial roles at Shire including VP Head of US Sales. Ms Törnsén will replace Mr Andrew Udell, who has held the position since 2020. .

在加入Sarepta之前，她曾担任赛诺菲Genzyme全球治疗领域副总裁，并在Shire担任过多个高级商业职位，包括美国销售副总裁。特恩女士将接替安德鲁·乌德尔先生，他自2020年起担任此职。

'We are pleased to welcome Ms Törnsén to the executive management team as President of our US operations. She brings invaluable experience from building commercial organisations, driving growth and profitability in the area of rare diseases, which will be critical as we target the next step in our development.' said CEO Renée Aguiar-Lucander.

“我们很高兴欢迎特恩女士加入执行管理团队，担任我们美国业务的总裁。她在建立商业组织、推动罕见疾病领域的增长和盈利方面带来了宝贵的经验，这对于我们下一步的发展至关重要。”首席执行官勒内·阿吉亚·卢坎德（ReneeAguiarLucander）表示。

'I also want to thank Mr Udell for his valuable contribution to the build-up of the US organisation and its early commercial success.'  .

“我还要感谢乌代尔先生为美国组织的建立及其早期商业成功做出的宝贵贡献。”。

'I am delighted to join Calliditas at this exciting time in the company's history, with the recent full FDA approval of TARPEYO® and an innovative late-stage pipeline in rare diseases. I look forward to working with the Calliditas team to continue advancing the TARPEYO® launch and develop our capabilities to support further growth.' said Maria Törnsén..

“我很高兴在公司历史上这个激动人心的时刻加入Calliditas，最近获得了FDA对TARPEYO®的全面批准，以及罕见疾病的创新晚期管道。我期待着与Calliditas团队合作，继续推进TARPEYO®的推出，并发展我们的能力，以支持进一步的增长。”玛丽亚·特恩斯说。。

Calliditas received full FDA approval of TARPEYO®(budesonide) delayed release capsules, a targeted treatment to reduce the loss of kidney function in patients with primary IgA nephropathy (IgAN) at risk of disease progression on December 20, 2023; the product has been granted conditional approval in Europe and China and is being commercialized by partners under the brand names of Kinpeygo and Nefecon, respectively.

2023年12月20日，Calliditas获得了FDA对TARPEYO®（布地奈德）缓释胶囊的全面批准，该胶囊是一种靶向治疗，可减少患有疾病进展风险的原发性IgA肾病（IgAN）患者的肾功能丧失；该产品已在欧洲和中国获得有条件的批准，并由合作伙伴分别以Kinpeygo和Nefecon的品牌进行商业化。

Calliditas is targeting top line read out of several Phase 2 clinical trials with setanaxib, its lead product candidate from its proprietary and novel NOX platform, in 2024..

Calliditas的目标是2024年使用其专有和新型NOX平台的主要候选产品西他那昔进行的几项2期临床试验的最终结果。。

For further information, please contact:

欲了解更多信息，请联系：

Åsa Hillsten, Head of IR & Sustainability, Calliditas

Ása Hillsten，Calliditas IR和可持续发展负责人

Tel.: +46 76 403 35 43, Email: [email protected]

电话：+46 76 403 35 43，电子邮件：[受电子邮件保护]

The information was sent for publication, through the agency of the contact persons set out above, on January 7, 2024 at 5:00 p.m. CET.

该信息于2024年1月7日欧洲中部时间下午5:00通过上述联系人的代理发送发布。

About Calliditas

关于卡利迪塔斯

Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).

Calliditas Therapeutics是一家总部位于瑞典斯德哥尔摩的生物制药公司，专注于识别，开发和商业化孤儿适应症的新型治疗方法，这些治疗方法具有重大的未满足的医疗需求。Calliditas的普通股在纳斯达克斯德哥尔摩（股票代码：CALTX）上市，其美国存托股在纳斯达克全球精选市场（股票代码：CALT）上市。

Visit Calliditas.com for further information..

有关更多信息，请访问Calliditas.com。。

Important Safety Information

重要安全信息

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.

禁忌症：对布地奈德或TARPEYO的任何成分过敏的患者禁用TARPEYO。其他布地奈德制剂也发生了严重的超敏反应，包括过敏反应。

Warnings and Precautions

警告和注意事项

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.

皮质类固醇激素和肾上腺轴抑制：长期使用皮质类固醇激素时，可能会出现皮质类固醇激素和肾上腺抑制等全身效应。皮质类固醇可以降低下丘脑-垂体-肾上腺（HPA）轴对压力的反应。在患者接受手术或其他压力情况下，建议补充全身皮质类固醇。

When discontinuing therapyor switching between corticosteroids, monitor for signs of adrenal axis suppression..

当停止治疗或在皮质类固醇之间转换时，监测肾上腺轴抑制的迹象。。

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).

由于口服布地奈德的全身暴露增加，中度至重度肝功能损害（分别为Child-Pugh B级和C级）的患者可能会增加皮质醇增多症和肾上腺轴抑制的风险。避免用于严重肝损伤患者（Child-Pugh C级）。

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

监测中度肝功能损害（Child-Pugh B级）患者皮质醇增多的体征和/或症状。。

Risks of immunosuppression: Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids.

免疫抑制的风险：服用抑制免疫系统药物的患者比健康人更容易感染。例如，水痘和麻疹在易感患者或服用免疫抑制剂量皮质类固醇的患者中可能会有更严重甚至致命的病程。

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..

避免对活动性或静止性结核感染患者进行皮质类固醇治疗；未经治疗的真菌，细菌，全身病毒或寄生虫感染或眼部单纯疱疹。避免接触活动性、易传播的感染（如水痘、麻疹）。皮质类固醇治疗可能会降低对某些疫苗的免疫反应。。

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..

其他皮质类固醇作用：TARPEYO是一种全身可用的皮质类固醇，预计会引起相关的不良反应。监测患有高血压，糖尿病前期，糖尿病，骨质疏松症，消化性溃疡，青光眼或白内障，或有糖尿病或青光眼家族史，或皮质类固醇可能产生不良影响的任何其他疾病的患者。。

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%)..

不良反应：在临床研究中，TARPEYO最常见的不良反应（发生率≥5%，比安慰剂高≥2%）是外周水肿（17%），高血压（12%），肌肉痉挛（12%），痤疮（11%），头痛（10%），上呼吸道感染（8%），面部水肿（8%），体重增加（7%），消化不良（7%），皮炎（6%），关节痛（6%），白细胞计数增加（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 activity, can increase the systemic exposure to budesonide..

药物相互作用：布地奈德是CYP3A4的底物。避免使用强效CYP3A4抑制剂，如酮康唑、伊曲康唑、利托那韦、茚地那韦、沙奎那韦、红霉素和环孢素。避免摄入含TARPEYO的葡萄柚汁。摄入抑制CYP3A4活性的葡萄柚汁可以增加布地奈德的全身暴露。。

Use in specific populations

在特定人群中使用

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.

怀孕：已发表的病例系列，流行病学研究以及孕妇口服布地奈德的评论的现有数据尚未确定与药物相关的重大出生缺陷，流产或其他不良孕产妇或胎儿结局的风险。与IgAN相关的母亲和胎儿存在风险。

Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism..

暴露于子宫内皮质类固醇（包括布地奈德）的婴儿有肾上腺功能减退的风险。。

Please see Full Prescribing Information

请参阅完整的处方信息

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development of Calliditas' pipeline. The words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'target,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

本新闻稿包含1995年《私人证券诉讼改革法案》修订版所指的前瞻性声明，包括但不限于关于Calliditas管道发展的声明。“可能”、“将”、“可能”、“将”、“应该”、“期望”、“计划”、“预期”、“打算”、“相信”、“估计”、“预测”、“项目”、“潜力”、“继续”、“目标”等词语都是用来识别前瞻性陈述的，尽管并非所有的前瞻性陈述都包含这些识别词。

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business, operations, clinical trials, intellectual property of the NEFECON franchise globally, competition from other companies, pipeline development, revenue and product sales projections or forecasts and other risks identified in the section entitled 'Risk Factors' in Calliditas' reports filed with the Securities and Exchange Commission.

本新闻稿中的任何前瞻性陈述均基于管理层当前的期望和信念，并受到许多风险、不确定性和重要因素的影响，这些风险、不确定性和重要因素可能导致实际事件或结果与本新闻稿中任何前瞻性陈述所明示或暗示的结果产生重大差异，包括但不限于，与Calliditas在全球范围内的业务、运营、临床试验、NEFECON特许经营的知识产权、其他公司的竞争、管道开发、收入和产品销售预测或预测以及在提交给证券交易委员会的Calliditas报告中“风险因素”一节中确定的其他风险有关的任何信息。

Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Calliditas提醒您不要过度依赖任何前瞻性陈述，这些陈述仅在做出之日起生效。Calliditas不承担公开更新或修订任何此类声明的义务，以反映任何此类声明所依据的预期或事件、条件或情况的任何变化，或者可能影响实际结果与前瞻性声明中所述结果不同的可能性。

Any forward-looking st.

任何前瞻性的st。

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/16574/3905099/2525032.pdf

https://mb.cision.com/Main/16574/3905099/2525032.pdf

M Törnsen Eng

M会话一