ST GALLEN, Switzerla--(뉴스와이어)--Regulatory News:

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Fresenius Kabi today announced an agreement to develop, register and distribute Veltassa® for the treatment of hyperkalemia in the People’s Republic of China. Under the agreement, Fresenius Kabi will have the exclusive right to distribute and sell Veltassa® across China.

Stefan Schulze, CEO of Vifor Pharma Group comments, “We are delighted to expand VFMCRP’s collaboration with Fresenius Kabi. There is a high prevalence of CKD and heart failure in China[3] and hyperkalemia is one of the most common complications associated with these two conditions. As a result there is a high demand for an effective, proven hyperkalemia treatment. The excellent commercial infrastructure, the well established relationships in nephrology and our existing successful collaboration make Fresenius Kabi our partner of choice to provide Veltassa® to patients.”

Oskar Haszonits, President Region Asia Pacific of Fresenius Kabi said, “This agreement is an important step in intensifying our collaboration and relationship with VFMCRP in nephrology. We believe Veltassa® has the potential to provide many benefits to patients across the country, and we look forward to adding it to our portfolio and working with VFMCRP.”

Hyperkalemia is a serious medical condition characterized by elevated levels of potassium in the blood and can be associated with life-threatening consequences. Patients with CKD and heart failure, especially those treated with RAAS (renin-angiotensin-aldosterone system) inhibitors are at particular risk of developing hyperkalemia. As a consequence, RAASi therapy, the cornerstone of treatment for CKD and heart failure, is often reduced or discontinued, compromising cardio-renal protection. By bringing Veltassa® to China, VFMCRP and Fresenius Kabi will deliver a treatment that will enable patients to remain on RAASi therapy by managing their chronic hyperkalemia.

Fresenius Kabi is a global healthcare company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. In China, the company is among the top 10 multinational pharmaceutical companies, being a market leader in clinical nutrition, anesthesia and nephrology. Fresenius Kabi has around 6,000 employees in China.

Both parties have agreed to not disclose financial terms of the collaboration.

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit viforpharma.com

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

With its corporate philosophy of “caring for life”, the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

For more information, please visit www.fresenius-kabi.com.

About Hyperkalemia

Approximately 73% of advanced Chronic Kidney Disease (CKD) and 40% of chronic heart failure patients may be at risk of elevated blood potassium levels[4]. Hyperkalemia can cause abnormal heart rhythms and even sudden death[5]. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease and reduce mortality can cause hyperkalemia as a side effect. These may include RAASi such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin converting-enzyme (ACE) inhibitors as well as angiotensin II receptor/neprilysin inhibitors (ARNI).

About Veltassa®

Veltassa® is a potassium binder approved for the treatment of hyperkalemia. Veltassa® was specially designed to exchange calcium rather than sodium for potassium ions, ensuring suitability for patients who cannot tolerate even small increases in sodium.Veltassa® should not replace emergency treatment for life-threatening hyperkalemia. Made in powder form, Veltassa® is mixed with water and taken once a day with or without food. Veltassa® is consisting of smooth, spherical, uniform microbeads too large to be absorbed, thus protecting the gastrointestinal tract. Veltassa® works primarily in the lumen of the colon where potassium concentration is highest, and the residence time of the polymer is the longest. The potassium is then excreted from the body through the normal excretion process.

[1] Veltassa® EU SmPC 2019

[2] Agarwal R, et al. Lancet 2019;394:1540-50.

[3] Zhang et al. Lancet. 2012 Mar 3;379(9818):815-22; Guo et al. Int J Environ Res Public Health 2016; 13: E770. Guo et al. Curr Cardiol Rev. 2013 May; 9(2): 112-122.

[4] Rosano GCM, et al. Expert consensus document on the management of hyperkalaemia in patients with cardiovascular disease treated with renin angiotensin aldosterone system inhibitors: coordinated by the Working Group on Cardiovascular Pharmacotherapy of the European Society of Cardiology. Eur Heart J 2018;4:180-188.

[5] Rastegar A, Soleimani M. Hypokalaemia and hyperkalaemia. Postgrad Med J. 2001;77:759-764.

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