Press release | 26.4.2016
Munich, 26 April 2016 - For many decades, a complication known as infant respiratory distress syndrome (RDS) was the leading cause of death among pre-term infants born at least six weeks before their due date. Released in 1992, a natural drug derived from a phospholipid extract from the lungs of pigs radically improved survival rates among newborns with RDS. Co-invented by Swedish researcher Tore Curstedt (70) at Karolinska Institutet in Stockholm, treatments with "surfactants" protect the lungs of pre-term infants from collapse. Over a lifetime of research, the influential biochemist secured the invention's market entry and is currently perfecting an entirely synthetic alternative to the porcine chemicals.
For this achievement, the European Patent Office (EPO) has named Tore Curstedt as one of three finalists for the European Inventor Award 2016 in the category "Lifetime Achievement". The winners of the 11th edition of the EPO's annual innovation prize will be announced at a ceremony in Lisbon on 9 June.
"Tore Curstedt's invention is an achievement in fighting what was for many decades the leading cause of death in early-born infants," said EPO President Benoît Battistelli announcing the European Inventor Award 2016 finalists. "The inventor's lifelong dedication to making advances in this field has potentially saved the lives of hundreds of thousands of infants."
Thanks to Curstedt's invention, RDS is no longer the leading cause of death among newborns, and survival rates have improved tremendously. Studies conducted on infants with RDS have shown treatments with surfactants to reduce mortality and any form of pulmonary air leaks by about 30% and 50%, respectively.
The impact of this invention on neonatal care can hardly be overstated: As late as the 1950s and early 1960s, infant mortality from respiratory distress syndrome (RDS) was about 90% and the leading cause of neonatal death. The root cause of the deadly disease became known early on through the research of Mary Ellen Avery and Jere Mead at the Harvard School of Public Health, and their work was brought into medical practice by Japanese paediatrician Tetsuro Fujiwara.
In healthy lungs, a naturally occurring slippery surfactant liquid reduces the surface tension of alveoli, tiny chambers in the lungs that absorb oxygen from the air into the blood. Without this substance - which works much like soap does to maintain fragile soap bubbles - the delicate alveoli would collapse when the lungs exhale.
Early-born infants often lack this protective coating, putting them at great risk for pulmonary complications.
Starting in 1980, Curstedt and his colleague Bengt Robertson (1935-2008) began investigating the use of pig-derived surfactant for medical treatment under the chemical name poractant alfa. The resulting treatment - since named Curosurf (Curstedt- Robertson Surfactant) after its two developers - was approved for use in Europe in 1992 and by the US FDA in 1999. Today, it is available in 80 countries around the world. Applied through a breathing tube inserted into a newborn's trachea, the treatment approach yielded promising results in clinical trials. However, the inventors had to overcome significant challenges on the manufacturing side. Scaling up production for Curosurf proved difficult because a lung from one pig yielded only enough surfactant for treating two new-born infants. Ultimately, Curstedt and his colleague won support from family-owned company Chiesi Farmaceutici in Parma, Italy, to advance the natural surfactant to market.
The innovation ushered in a new outlook on treating newborns with lung disease. Curstedt's surfactants have since been used to treat over three million newborns with RDS and other lung diseases. At the moment, roughly one in eight births in the US and about one in fourteen births in Europe occur pre-term, according to the National Center for Health and European Foundation for the Care of Newborn Infants, respectively. To put this in perspective, that means 450 premature births per hour in the EU. The wide-spread availability of surfactant treatments have helped reduce infant mortality significantly: As of 2015, mortality rates for RDS have dropped below 5% in the developed world. Moreover, the drug has not only become the standard treatment for newborns with RDS but is now administered routinely on all infant babies under 30 weeks' gestation (10 weeks premature) needing intubation.
The life-saving effects Curstedt's medication has for infants around the world motivates him to continue research and postpone full retirement. Personal encounters with RDS survivors have been very emotional, says Curstedt: "I was fortunate to meet the first patient treated with Curosurf outside of Sweden. In 2005, while at a seminar in Belfast, Northern Ireland, we were approached by a young man who had started university. He thanked us for his life: 'Without you, I wouldn't be alive today.' This leaves a very strong impression on you."
Curstedt began his career in 1974 by earning his PhD from the Department of Medical and Physiological Chemistry at the Karolinska Institutet in Stockholm. Specialising in phospholipid metabolism, he has dedicated his career to advancing treatments for infants with RDS. Curstedt remained at his alma mater in various positions, including Associate Professor and Senior Lecturer in Medical Chemistry (1975-1979), laboratory doctor (1980-2004) and Assistant Director of the largest clinical laboratory in northern Europe (2004). Retired from his Assistant Director position in 2013, the pioneer remains active in research, currently working on phase-II clinical trials for an entirely synthetic surfactant, CHF5633, which is less expensive and easier to manufacture at scale, with an estimated release in 2019. The author of 14 patents and some 200 original articles, Curstedt has been recognised with numerous awards, including the Hilda and Alfred Eriksson's Prize by the Royal Swedish Academy of Sciences (1998), the Swedish Heart-Lung Foundation's Lars Werkö Prize (2004) (jointly with co-inventor Robertson), and the Chiesi Prize for Excellence in Neonatology (2011).
Not only a lifesaver for hundreds of thousands of pre-term infants, Curosurf has also been a stellar economic success with a 73% global market share. In 2014, family-controlled Chiesi reported EUR 175 million in sales from Curosurf. The company ranges among Europe's leading think tanks in the development of new drugs with an annual R&D commitment of roughly EUR 237 million. Competing against a handful of other synthetic and naturally-derived surfactant medications, Curosurf has consistently shown better results. In a recent study, premature infants with RDS had a nearly 20% better chance of survival with Curosurf compared to the two major competing surfactants. Third-party analysts estimate the market for neonatal pre-term infant care (equipment, drugs and formulae) in the US at EUR 13.04 billion in 2015. A separate study looking only at European neonatal care equipment predicts this market to reach EUR 1.51 billion (USD 1.79 billion) by 2019.
Under the leadership of Tore Curstedt as Assistant Director, the Karolinska Institutet's Laboratory emerged as the largest clinical laboratory in northern Europe. It thereby joins the league of European think tanks advancing the state of the art in numerous fields with patented inventions and strategic connections to the realms of enterprise and government. Read more about Europe's leading research institutes.
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European Patent Office
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