Press release | 26.4.2017
Munich, 26 April 2017 - Worldwide, over 200 million people suffer from chronic kidney disease. For decades, doctors were unable to stop the decline of the kidney's ability to cleanse the blood, often leading patients into lifelong dependency on blood dialysis machines. Treatment outcomes have greatly improved - and dialysis is no longer an inevitable fate for millions of patients - thanks to a new class of medications developed by Italian nephrologist Giuseppe Remuzzi (68) and fellow researchers Carlamaria Zoja (61) and Ariela Benigni (61). Used for treating chronic kidney disease (CKD) and complications from organ transplants since the mid-1990s, their drugs based on enzyme inhibitors have become standard treatments around the globe.
For this achievement, Giuseppe Remuzzi, Carlamaria Zoja, and Ariela Benigni have been nominated as finalists for the European Inventor Award 2017 in the category "Industry". The winners of the 12th edition of the European Patent Office (EPO)'s annual innovation prize will be announced at a ceremony in Venice on 15 June.
"These researchers are global leaders in the fight against chronic kidney disease. Their ground-breaking insights into its causes give new hope to millions," said EPO President Benoît Battistelli announcing the European Inventor Award 2017 finalists. "The researcher team's innovations have elevated the level of care and treatment outcomes for patients, showing that dialysis is not a foregone conclusion for people with chronic kidney disease."
Although a simple test can provide early warning - increased protein levels in the urine signal decreased kidney function - many patients only seek help with advanced symptoms. "The heart beats, the lung breathes - but the kidney makes no noise, and often people end up presenting with end-stage kidney disease having never realised anything was wrong," says Giuseppe Remuzzi. At that stage, doctors used to be powerless to stop CKD - or kidney inflammation after organ transplants - from progressing into organ failure and lifelong dependence on dialysis machines.
Today, dialysis is no longer inevitable thanks to the medications developed by the Italian nephrologist and his fellow researchers Carlamaria Zoja and Ariela Benigni. The team achieved its breakthrough after Remuzzi discovered the kidney-saving properties of certain enzyme inhibitors in the late 1980s. Conventionally used against hypertension, these inhibitors provided the key mechanism behind the team's patent-protected drugs, which are now standard treatments for CKD worldwide.
Working with Carlamaria Zoja and Ariela Benigni at the Mario Negri Institute for Pharmacological Research's Bergamo branch, which he founded, Remuzzi formulated specific drugs for CKD that have been licensed by global pharmaceutical companies. The Institute has not adopted a policy of having its own developments patented, but permits its partners to do so: "If we patented our results ourselves, we would be bound to secrecy clauses for many years until our research became available to everyone, and benefitted the patients. But that doesn't mean that our inventions are not used commercially. We don't patent them ourselves, but we do allow companies that support us in our research to patent them - in their company's name. We remain the inventors, but the patenting is done by industry," says Remuzzi.
While the team's insights into CKD have proven instrumental for the scientific understanding of renal disease, their patented drugs opened up entirely new market segments. Brought to market by pharmaceutical company Merck in 1995 in the EU and US, Losartan sales reached EUR 1.46 billion in 2011, according to analysts IMS Health. Approved in 1997 for treating hypertension, Irbesartan achieved sales of EUR 774.9 million for Sanofi in 2015. Meanwhile, global incidences of chronic kidney disease show no sign of slowing down. The US market for kidney failure treatment was already worth EUR 36.1 billion in 2016 and is poised to reach nearly EUR 41.7 billion by 2021 (BCC Insights).
On the heels of their breakthroughs, the three researchers are leading the fight against CKD globally. Giuseppe Remuzzi earned his medical degree at the University of Pavia in 1974, and changed the understanding of renal disease when he published his new approach to CKD therapy in The Lancet in 1977. Today, Giuseppe Remuzzi is an international authority in his field and, with some 1300 scientific articles he is the most cited clinical researcher in Italy. He serves teaches as Professor of Nephrology at the University of Milan, as well as Director of the Department of Immunology and Clinical Transplantation (since 1996) and the Department of Medicine (since 2011) at Bergamo Hospital. In 1984, he established the Bergamo branch of the non-profit Mario Negri Institute for Pharmacological Research and works as its research coordinator. A tireless advocate of early testing, the inventor supports the International Society of Nephrology's (ISN) "0by25" initiative for zero preventable deaths from kidney disorders by 2025. He has received numerous honours including the ISN Jean Hamburger Award (2005), John P. Peters Award (2007) and the ISN AMGEN Award (2011).
Carlamaria Zoja and Ariela Benigni both earned their degrees in biological sciences from the University of Milan and PhDs from the University of Maastricht (both in 1979 and 2001 respectively). After joining Remuzzi at the Mario Negri Institute in Bergamo, Carlamaria Zoja rose to become head of the Laboratory of Physiopathology of Experimental Renal Disease and Interaction with other Organ Systems. The author of more than 170 scientific publications and new multidrug therapies for CKD, Zoja is listed as one of the most influential female Italian scientists. Ariela Benigni is currently the head of the Institute's Department of Molecular Medicine. She has authored over 270 peer-reviewed articles and lectured at more than 140 national and international meetings. A recipient of the Citta di Bergamo Merit Award, Benigni has previously consulted the World Health Organization (WHO) as a leading expert on progressive kidney disease.
As the research coordinator of the Bergamo branch of the Mario Negri Institute for Pharmacological Research, Giuseppe Remuzzi encourages "his" scientists to pursue innovation without commercial motives. Created in 1963 as a non-profit research institution in Milan, the Institute pursues a policy of not seeking patents for its inventions, but allowing other companies to patent its research. Free from commercial priorities, Mario Negri Institute's scientists can explore research into rare and so-called "orphan diseases" which are often neglected as "unprofitable" by pharmaceutical companies. Read more about European research institutes.
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