22 August 2013

International partnership receives funding to develop a drug product to fight schistosomiasis (bilharzia) in children

An international public-private partnership (PPP) was launched in July last year to develop a new pediatric formulation to combat schistosomiasis - commonly known as bilharzia - in preschool children.

The Bill & Melinda Gates Foundation grants $1.15 million to support some research & development activities before Phase I clinical trials. The current partners in this consortium, coordinated by TI Pharma, are Merck KGaA, Astellas Pharma Inc. and the Swiss Tropical and Public Health Institute ("Swiss TPH").

Schistosomiasis is a severe chronic inflammatory disease caused by parasitic worms and is endemic in 78 developing countries, infecting more than 243 million people globally every year. Schistosomiasis is the second most prevalent tropical disease in the world after malaria, and occurs primarily in developing countries with limited access to safe drinking water and adequate sanitation. If not treated properly, the disease can lead to anemia, stunting and reduced learning ability, and can be fatal. The consortium's goal is to develop a suitable pediatric drug for preschool children, a high-risk group for schistosome infections counting for 10-20 million of the global prevalence. The standard recommended praziquantel treatment is available in oral tablets for adults and children from the age of six. Younger children cannot always swallow these tablets because of their size and bitter taste. An appropriate treatment with praziquantel for preschool children is non-existent and highly needed. The amount from the Gates Foundation was granted to Merck, one of the consortium partners, and will be used to finance some important R&D activities needed to bring the product up to the first clinical studies in man. It will also allow the involvement of disease experts, including from countries affected. Altogether, this will ensure that the product to be developed fits the needs of the pediatric population best.

Annalisa Jenkins, Chair of the Consortium Board and Head of Global Drug Development and Medical at Merck Serono, the biopharmaceutical division of Merck: "There is an urgent need for the treatment of schistosomiasis in very young children, for whom there is currently no approved therapy. The support of the Gates Foundation is a key step in moving forward with new options for this highly vulnerable population with the ultimate goal of elimination."

About Astellas Pharma Inc.

Astellas Pharma Inc., based in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas Pharma Inc. has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology (including Transplantation) and Infectious Diseases, Oncology, Neuroscience, and DM Complications and Kidney Diseases. Astellas Pharma Inc. is committed to increasing access to health in developing countries through its partnership initiatives. Astellas Pharma Inc.'s pharmaceutical research and technology labs have contributed to improving convenience for use and the functionality of treatments by developing novel formulations and bringing additional value based on its excellent pharmaceutical technologies (e.g. solubilization, controlled release, oral disintegration tablet and drug delivery technologies). For more information, please visit www.astellas.com/en

About Merck KGaA

Merck is a leading pharmaceutical, chemical and life science company with total revenues of € 11.2 billion in 2012, a history that began in 1668, and a future shaped by approx. 38,000 employees in 66 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since. The Merck Praziquantel Donation Program was launched in 2007 in partnership with WHO. Since then more than 100 million tablets have been supplied and over 28 million children have been treated. By 2011, Merck's annual donation had grown to about 25 million tablets. At the beginning of 2012 Merck announced that it will fight schistosomiasis until the disease will be eliminated in Africa. To reach this goal the company will increase the annual donation of tablets tenfold in the medium term. For more information, please visitwww.merckgroup.com

About Swiss TPH

Swiss TPH is an associated institute of the University of Basel. Its mandate is to contribute to the improvement of public health at international, national and local levels through excellence in research, services, teaching and training. The strategy to pursue this mandate is based on a broad interdisciplinary approach for a sustainable iterative process between the laboratory, field, classroom and bedside. Swiss TPH addresses the continuum between innovation (developing concepts, methods and products), validation (providing evidence for what works) and application (strengthening public health systems & policies). Over 500 staff members from 58 nations are organized in two research and three service departments. For more information, please visit www.swisstph.ch