VFMCRP announces positive results of phase-III clinical trial of Velphoro ® in China
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced positive results from a phase-III study in China (PA-CL-CHINA-01), evaluating the efficacy of Velphoro® (PA21) compared to sevelamer carbonate in lowering and maintaining serum phosphorus in adult Chinese patients with chronic kidney disease (CKD) on dialysis after 12 weeks of treatment. The study met its primary endpoint demonstrating non-inferiority versus sevelamer carbonate in the change from baseline in serum phosphorus levels at week 12.
Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented, “We are delighted by the positive results from the PA-CL-CHINA-01 study, which confirm previous data generated in the US and Europe, and reinforce the potential of Velphoro® as an important new treatment option for dialysis patients with hyperphosphatemia in China where there is a high prevalence of CKD1. This is another important step in our geographic expansion and will further strengthen the position of Velphoro® as a global leader in the calcium-free phosphate binder market2.”
Importantly, patients who received Velphoro® experienced additional benefits compared to those in the sevelamer control group: Serum phosphorus levels in patients treated with Velphoro® declined faster than in the sevelamer group and the average number of tablets taken daily (3.23) was significantly lower than with sevelamer carbonate (6.31). Safety results were consistent with the known safety profile of Velphoro® with no new safety signal observed in Chinese CKD patients with hyperphosphataemia.
VFMCRP intends to submit the Chinese New Drug Application to the National Medical Products Administration’s CDE at the end of 2021.
About the PA-CL-CHINA-01 study
This phase-III study was designed to demonstrate non-inferiority of the change from baseline at week 12 in serum phosphorus between PA21 (Velphoro®) and sevelamer carbonate, and support market expansion of Velphoro® to China. PA-CL-CHINA-01 was an open-label, active-controlled, parallel group, multicenter study with a total of 286 patients randomized: 142 in the Velphoro® arm and 144 in the sevelamer arm. No major protocol deviation related to COVID-19 were reported and no patients were excluded from the Per Protocol Set (PPS) due to COVID-19.
Velphoro® is a non-calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood of adults with CKD on dialysis. Velphoro® has been launched in over 30 countries, with more than 100,000 patients estimated to use the drug on a yearly basis. In 2020, Velphoro® became a global leader by value in the calcium-free phosphate binder market2.
1 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.
2 Monthly IQVIA MIDAS panel, INSIGHT Health & DN, GERS, DLI, Farminform | 03.2020.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Global Head Corporate Communications
+41 79 957 96 73
Head of Investor Relations
+41 58 851 66 90
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Altium Advances STEM Education with Expanded Curriculum and New Partnerships5.8.2021 09:00:00 CEST | Press release
In September 2020, Altium LLC, the leading printed circuit board (PCB) software company, launched Upverter Education, a free distance learning initiative to support STEM educators. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210805005356/en/ Start your school year right with Upverter Education, an award-winning electronics design curriculum. (Photo: Altium LLC) The free Electronics Design Essentials program was designed for high school STEM teachers covering everything from engineering to robotics, with guided courses, certification and Upverter, an easy-to-use web-based tool for electronics design. Rea Callender, Vice President of Altium Education, elaborates, “Through Altium’s education initiatives, beginning with Upverter Education, we are introducing students of all ages to electronics design and sparking passion in people where they never knew it existed. You can’t have a passion for something if you don’t know it ex
Servify's Massive Growth Leads to Expansion of Global Team with Key Hires Across Business Domains5.8.2021 07:30:00 CEST | Press release
Servify, a leading provider of Extended Care and Product Protection solutions using its global, AI-enabled, digital platform, has announced hiring of senior leaders across regions and functions to drive its global expansion. Arun Verma, MS Kalsi, Kevin Cundiff, Edward Lee, Swetha Prashant, Peter Duesing, Sanghoon (Sam) Kwon, Hussein Hussein and Sergey Odinets have all been hired to bolster various verticals and regions within the organisation. Arun Verma, with more than 20 years of experience, was appointed as the Chief Human Resources Officer. He has championed impressive success in people management across distinctly diverse industries such as Technology & Services, Finance, Management Consulting & FMCG. He worked as CHRO and Head of Administration of Beetel before Servify, and with the likes of Xerox India, McKinsey & Co., Reliance Capital Limited, and CavinKare in the past. Makhan Singh Kalsi, also known as M S Kalsi, joins Servify as its Chief Service Officer after previously serv
Vifor Pharma reports strong H1 2021 growth, on track to meet full year guidance 15.8.2021 07:00:00 CEST | Press release
Regulatory News: Vifor Pharma Group reported profitable revenue growth in H1 supported by a strong recovery in Ferinject® / Injectafer® with sales up 22.8% at CER as a result of improved patient access as COVID-19 restrictions eased in key markets. Based on the solid results in H1 2021, the Group is confident of achieving its full year guidance. FINANCIAL PERFORMANCE2: CONTINUED OVERALL GROWTH Reported net sales of CHF 859.3 million, up 1.5% (up 5.0% at CER) EBITDA of CHF 281.0 million, up 0.2% (up 5.3% at CER). Excluding other income, EBITDA increased 9.4% (up 15.0% at CER) Other income of CHF 20.4 million, down 51.7% due to lower income from partnering and other activities Gross profit margin of 62.5%, up 1.4 percentage points driven by higher share of sales from the iron portfolio Net profit attributable to shareholders of Vifor Pharma Ltd. of CHF 124.4 million, driven by lower depreciation, amortization and impairment, as well as the strong net financial result in H1 2021 Strong ba
Kyoto Semiconductor Co., Ltd. Launches New Photodiode Demonstrating Superior Performance With Semtech’s Linear Transimpedance Amplifier5.8.2021 07:00:00 CEST | Press release
Kyoto Semiconductor Co., Ltd. (President and CEO Tsuneo Takahashi, Head office: Fushimi-ku, Kyoto city), a leading optical device solution manufacturer with world-class technologies and Japanese quality, announced its collaboration with Semtech Corporation (Nasdaq: SMTC), a leading supplier of high performance analog and mixed-signal semiconductors and advanced algorithms. Kyoto Semiconductor has chosen to pair their new KP-A avalanche photodiode*1, KPDEA13C with Semtech’s GN1089 transimpedance amplifier*2 to enable long distance optical communication. "The pairing of Semtech’s transimpedance amplifier GN1089 with Kyoto Semiconductor’s KPDEA13C was ideal to optimize the performance,” said Tsuneo Takahashi, Kyoto Semiconductor president and CEO. “Through the joint collaboration, the KPDEA13C now includes a fast response suitable for a variety of optical needs.” Kyoto Semiconductor’s KPDEA13C is front side illuminated, highly sensitive and mounted on an interposer board for ease of assem
Thales Partners with DAS in Fully Supporting Hong Kong International Airport's Three-Runway System Expansion Project5.8.2021 04:00:00 CEST | Press release
Thales and Dah Chong Hong – Dragonair Airport GSE Service Ltd. (DAS) announced that they have been selected by the Civil Aviation Department (CAD) of the Hong Kong Special Administrative Region Government through global open tender exercise to deploy the new Instrument Landing System (ILS) and to support the Three-runway System (3RS) expansion project at the Hong Kong International Airport (HKIA). This leading solution will largely help HKIA further improve the capacity and efficiency of aircraft landing while maintaining the highest standard of flight safety. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005024/en/ © Hong Kong International Airport The six sets of new ILS to be installed at the HKIA under 3RS will make use of Thales state-of-the-art technologies. The new ultra-wide aperture localizer array with 32-element localizer antenna will provide highly accurate guidance signals to aircraft approaching and land
Northleaf Expands Business Development Team With the Addition of Chris O’Connor as a Managing Director for Australia and New Zealand5.8.2021 02:00:00 CEST | Press release
Northleaf Capital Partners (Northleaf) is pleased to announce the appointment of Chris O’Connor as Managing Director, Business Development, Australia and New Zealand. In this new role, Chris will lead Northleaf’s business development and investor relations activities and further develop relationships with institutional investors, consultants and advisors in the region. Chris joins Northleaf’s existing Melbourne-based investment team, extending the firm’s ongoing commitment to private markets activities in Australia and New Zealand. “We are thrilled to welcome Chris to the Northleaf team as our first Australia-based business development executive,” said Jeff Pentland, Managing Director and Head of Business Development at Northleaf. “Chris brings expertise in both relationship building and consultative fundraising, enhancing our capabilities to provide investors with access to highly differentiated mid-market infrastructure, private equity and private credit investments globally.” Prior
Australian Small Businesses Need Greater Access to Finance, According to Taulia5.8.2021 00:00:00 CEST | Press release
Small businesses in Australia continue to unnecessarily struggle when accessing affordable finance and deserve greater options, according to Taulia, the leading fintech provider of working capital solutions. In a new paper, Taulia has outlined the multiple challenges facing Australian small businesses - who often act as suppliers to large local and international businesses - regarding access to finance. Small businesses are the driving force behind Australia’s economy, accounting for 35% of GDP and 44% of employment, but the Reserve Bank of Australia’s analysis of the COVID-19 pandemic shows that lending to these smaller firms has been relatively flat since January 2019. Taulia attributes this ongoing lack of finance to five key causes: The long-term challenge small businesses have had in accessing finance, particularly from traditional banking sources Fewer resources within small businesses dedicated to understanding liquidity risk and cash flow, which can mean they only realise their
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom