New treatment option for patients with SHPT ‒ Rayaldee® now available in Switzerland

New treatment option for patients with SHPT ‒ Rayaldee^® now available in Switzerland

Fribourg, Switzerland, 1 March 2022 – Vifor Pharma Switzerland Ltd. today announced the Swiss launch of Rayaldee^® (extended-release calcifediol), the first and only oral therapy approved in Europe for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and low vitamin D levels (25-hydroxyvitamin D serum levels <30 ng/ml).

“We are very excited to introduce Rayaldee^® as a new treatment option for CKD patients in Switzerland living with SHPT”, said Jörg Storre, General Manager of Vifor Pharma Switzerland Ltd. “The launch in Switzerland demonstrates our commitment to providing innovative medicines to support patients and healthcare providers. We are confident that Rayaldee^® can become the new standard of care supporting better outcomes for patients and reducing the challenging complications brought on by the disease.”

“SHPT is a chronic progressive disease which increases in severity as CKD worsens. If not treated early and adequately, patients face serious disease burdens over time”, said Prof. Dr. med. Patrice Ambühl, Medical Director Stadtspital Waid Zurich, Switzerland. “We are confident that this new medication allows us to better manage this disease and patient’s quality of life, meeting major unmet medical need in the treatment of SHPT.”

Approval of Rayaldee^® is based on a comprehensive clinical trial program assessing the efficacy and safety of Rayaldee^® for the treatment of SHPT in non-dialysis CKD patients. These studies showed that treatment with Rayaldee^® resulted in clinically meaningful reductions in plasma intact parathyroid hormone (iPTH) and resolution of Vitamin D insufficiency. It was also found to be well tolerated in patients with CKD stage 3 or 4 and associated with positive effects on bone turnover markers.

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and includes the companies: Vifor Pharma, Sanifit Therapeutics, 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

About Rayaldee^® (extended-release calcifediol)

Rayaldee^®, developed by OPKO Health, Inc., is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine authorized by the U.S. Food and Drug Administration for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). Rayaldee^® is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the US and in 11 European countries.