Business Wire

First patient treated in DIAMOND study to evaluate if Veltassa® (patiromer) improves outcomes by enabling long-term use of essential RAASi therapy

Share

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190520005695/en/

Vifor Pharma today announced that treatment of the first patient in their global phase-IIIb DIAMOND study has begun. The study will evaluate the potential of Veltassa® to improve outcomes by enabling heart failure (HF) patients, with or without chronic kidney disease (CKD), to be treated with renin-angiotensin-aldosterone system inhibitors (RAASi) therapy in accordance with HF treatment guidelines1,2. Presently, RAASi treatment is frequently discontinued due to the risk of hyperkalaemia (elevated blood potassium levels).

The DIAMOND study is designed to further support the use of Veltassa® to effectively control high blood potassium levels, thereby enabling optimal RAASi therapy in HF patients. It is a global, multicentre, double-blind, placebo-controlled trial aiming to study approximately 2,400 patients in over 400 sites. Eligible patients will have HF (with or without CKD) with either current hyperkalaemia at screening or a history of hyperkalaemia in the past year that led to a reduction or discontinuation of RAASi therapy. The primary endpoint of the study is the time to first occurrence of cardiovascular death or cardiovascular hospitalisation. Top-line results are expected in 2022.

Hyperkalaemia can cause life-threatening abnormal heart rhythms and even sudden death3. There are often no warning signs, meaning a person can unknowingly experience recurring spikes in potassium levels and be at risk of cardiac events. The risk of hyperkalaemia can be a barrier to initiating and maintaining HF and CKD patients on guideline-recommended therapies such as RAASi treatment1,2.

RAASi therapy has been shown to improve cardiovascular and renal outcomes and is proven to prolong survival and reduce hospitalisation. Its use is strongly recommended in clinical guidelines for the treatment of HF with reduced ejection fraction, and CKD1,2. Across the Veltassa® clinical trial program, over 99 percent of participants were also taking RAASi therapy. However, these therapies can increase blood potassium levels, which can lead to hyperkalaemia.

“Guidelines give their strongest recommendation to use RAASi therapy to improve mortality and morbidity in patients with heart failure and with kidney disease, but unfortunately they are often discontinued because they can cause hyperkalaemia,” said Professor Javed Butler, primary investigator of the DIAMOND study and chairman of the Department of Medicine, University of Mississippi Medical Center, US. “DIAMOND is a very important study that will help the medical community better understand the value of Veltassa® in treating hyperkalaemia and enabling patients to stay on these life-saving medicines.”

Additional details on the study are available on www.clinicaltrials.gov.

About Hyperkalaemia
Approximately 73 percent of advanced CKD and 40 percent of chronic HF patients may be at risk of elevated blood potassium levels4. Hyperkalaemia can cause abnormal heart rhythms and even sudden death3. 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 hyperkalaemia 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 sodium-free potassium binder approved for the treatment of hyperkalaemia. Veltassa® should not replace emergency treatment for life-threatening hyperkalaemia. Made in powder form consisting of smooth, spherical beads, Veltassa® is mixed with water and taken once a day with food. Veltassa® is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

Important Safety Information about Veltassa ® in the United States

Contraindications
Veltassa® is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa® or any of its components.

Worsening of Gastrointestinal Motility
Use of Veltassa® should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa® may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia
Veltassa® binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa®. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.

Adverse Reactions
The most common adverse reactions (incidence ≥2 percent) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa® and included edema of the lips.

For Veltassa®’s full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.

Vifor Pharma Group is a global pharmaceuticals company headquartered in Switzerland. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the 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; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); Relypsa; and OM Pharma. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.

Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialisation of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The company's first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalaemia in more than 50 years. More information is available at www.relypsa.com.

References

1 Yancy C et al. American Heart Association. Guideline for the Management of Heart Failure. August 2017. Accessible via http://www.ksw-gtg.com/hfguidelines/pdfs/HFTreatmentHypertensionHFrEF.pdf.

2 Ponikowski P et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) European Heart Journal, Volume 37, Issue 27, 14 July 2016, Pages 2129–2200.

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

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.

Contact information

Media Relations
Heide Hauer
Head of Corporate Communications
+41 58 851 80 87
media@viforpharma.com

Media Relations (US)
Albert Liao
Director of US Communications Relypsa
+1 650 421 9532
media@relypsa.com

Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Acrisure and Tulco Unveil Altway Insurance19.9.2019 19:00:00 EESTPress release

Top 10 global insurance broker Acrisure and leading investment company Tulco Holdings unveils Altway Insurance, a direct-to-consumer brokerage platform which is fully supported by artificial intelligence. Altway Insurance represents a unique blend of a world-class AI firm matched with an insurance broker with an equally world-class distribution network. Additionally, Google Cloud is working closely with the company on how to integrate Google's most cutting-edge AI technology into new AI applications. Tulco Chairman and CEO Thomas Tull said, “While there has been substantial investment to fuse technology and insurance, today, there remains a massive and unmet opportunity to truly create the broker of the future. To meet that opportunity, we're thrilled to combine the AI and analytics leadership of Tulco with the phenomenal growth and global distribution power of Acrisure.” Underlying Altway is the unique combination of Acrisure and Tulco. Acrisure delivers high quality insurance service

Mindbreeze recognized once again as a Leader in the 2019 Gartner Magic Quadrant for Insight Engines19.9.2019 18:20:00 EESTPress release

Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for international companies, announced today that the company has been positioned by Gartner, Inc. as a Leader in the 2019 Magic Quadrant for Insight Engines. A complimentary copy of the report can be accessed from the Mindbreeze website “Mindbreeze enables our customers and their employees to garner and leverage crucial insights from their data. We work directly with our customers in this innovative field to bring meaning and value to their information assets that take us to the next level together,” comments Daniel Fallmann, Mindbreeze CEO and founder. “We believe this recognition further validates Mindbreeze’s success in the AI and knowledge management industry, as enterprises achieve ideal results using our unique and innovative solution.” Download the 2019 Magic Quadrant for Insight Engines now Many well-known custo

Amazon Co-founds The Climate Pledge, Setting Goal to Meet the Paris Agreement 10 Years Early19.9.2019 18:15:00 EESTPress release

Today, Amazon (NASDAQ: AMZN) and Global Optimism announced The Climate Pledge, a commitment to meet the Paris Agreement 10 years early. Amazon today becomes the first signatory of this pledge. The Climate Pledge calls on signatories to be net zero carbon across their businesses by 2040—a decade ahead of the Paris Accord’s goal of 2050. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190919005609/en/ Companies that sign The Climate Pledge agree to: Measure and report greenhouse gas emissions on a regular basis; Implement decarbonization strategies in line with the Paris Agreement through real business changes and innovations, including efficiency improvements, renewable energy, materials reductions, and other carbon emission elimination strategies; Neutralize any remaining emissions with additional, quantifiable, real, permanent, and socially-beneficial offsets to achieve net zero annual carbon emissions by 2040. “We’re done b

In Impact Investing First, LeapFrog Announces Audit on Impact Principles, Achieving Top Rating19.9.2019 18:02:00 EESTPress release

LeapFrog Investments today became the first impact investor globally to announce the results of an independent audit of its impact against the Operating Principles for Impact Management, new industry standards developed by the IFC in consultation with leading impact investors and other stakeholders. Launched in April, the Principles provide common disciplines for management of investments for impact, helping to ensure authenticity and high standards of measurement. In the independent audit by Tideline, a leading US impact advisory consultancy, LeapFrog was assessed as an “Exemplification of industry best practice,” with its Impact Measurement and Management (IMM) system achieving “an advanced level of alignment across the board for all nine of the Principles.” Tideline concluded that “LeapFrog’s IMM comprehensively addresses and exceeds the implementation guidance provided by the IFC and has been refined and strengthened over the course of several funds.” “The impact investing industry

Andersen Global Expands Reach in London19.9.2019 16:30:00 EESTPress release

Andersen Global continues its expansion in the UK as Miles Dean, Zoe Wyatt and their team join the Andersen Tax LLP team in the UK. This addition brings further depth to the group in London and enhances the team’s ability to work with clients holistically and provide best-in-class, seamless service. Andersen Global has a presence in five locations in the UK through its member and collaborating firms. Miles and Zoe previously worked at Milestone which was founded by Miles Dean in 2008, with Zoe Wyatt joining as a partner in 2015. As part of Andersen Tax LLP, these partners will continue to provide a broad range of international tax services to corporations and private clients, investment funds and real estate investors and developers. Milestone signed a collaboration agreement with Andersen Global in 2018 and the positive impact of this relationship has led to Miles, Zoe and their team now joining the Andersen Global member firm in the UK. “It was so important to us to ensure we are pos

CGLytics and Glass Lewis Set a New Standard for Transparency in Equity-based Compensation19.9.2019 16:15:00 EESTPress release

CGLytics, a leading global provider of governance data and analytics, and Glass Lewis, the world’s leading independent provider of governance and engagement support services, today announced the launch of Glass Lewis’ Equity Compensation Model (ECM) - a powerful new application for assessing U.S. equity-based compensation plans, available exclusively via CGLytics. This new application provides invaluable intelligence with year-round, on-demand access to Glass Lewis’ methodology which is used to evaluate the overall favorability of current and future equity plans, including tests against 11 key criteria. Companies and investors can now instantly test, review and adjust the same individual inputs as Glass Lewis’ analysts to ensure the best compensation, engagement and voting outcomes for their respective sides. The ECM provides companies with immediate and proactive insight into the concerns regarding current and future equity plans, which Glass Lewis highlights to more than 1,300 invest

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