Pediatric Praziquantel Consortium Expands Into Brazil

LEIDEN, The Netherlands, March 26, 2014 /PRNewswire/ --

Goal  is  to  make  treatment  for  schistosomiasis  accessible  to  children  under  six  years  of  age  in  endemic  countries

Brazilian Farmanguinhos, part of Fiocruz, and UK-based Simcyp are reinforcing the international non-profit Pediatric Praziquantel Consortium. The aim of the Consortium is to develop and register a new pediatric formulation against schistosomiasis for preschool-age children, a group currently lacking a suitable treatment.  If not treated properly, the parasitic disease results in high morbidity involving anemia, stunting and reduced learning ability. In some cases, it can also be fatal. Farmanguinhos brings its expertise in pharmaceutical manufacturing in endemic countries and Simcyp its pharmacokinetic modeling capabilities. Both partners join the Consortium at a crucial point in which the program is ready to move into the clinical stage.

The know-how of Simcyp and Farmanguinhos complements the existing scientific, regulatory and access expertise provided by the founding partners of the Pediatric Praziquantel Consortium. The Consortium is now in a strong position to start the clinical development program of a newly developed praziquantel pediatric formulation suitable for use in the very young children, including infants and toddlers.

Farmanguinhos, the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, brings unique expertise to produce and distribute the new pediatric product in endemic countries. Simcyp, a UK research-based company, will build and validate a pharmacokinetic model that will allow a better prediction of the appropriate dosage to be used in pediatric clinical trials. Stefan Oschmann, Member of the Merck Executive Board, comments, "We are very pleased to welcome Farmanguinhos and Simcyp to our partnership. Respectively, they bring critical manufacturing and drug modeling expertise to the consortium. Over the last year, we've made important progress across the pediatric praziquantel program, with advances in the clinic that will enable new options for young children suffering from schistosomiasis, and ultimately, accelerate our goal of eliminating the disease altogether."

For Brazil, this partnership opens up a range of opportunities. Hayne Felipe, director of Farmanguinhos says, "We look forward to this collaboration and see this as a breakthrough in the battle against schistosomiasis in infected young children, a group lacking suitable treatment until now. At Farmanguinhos, we ultimately aim at providing access to the drug directly to millions of young children in Brazil."

With the integration of Simcyp, the Pediatric Praziquantel Consortium acquires modeling expertise in the area of pediatric development. Simcyp's model will incorporate the relevant metabolic interactions related to ethnicity and disease state. By doing so, it will enable the Consortium to better predict the appropriate dosage for the pediatric clinical trials in preschool-age children, which is important for the development program.

Schistosomiasis, endemic in 78 developing countries, is a chronic inflammatory disease caused by parasitic worms. The disease affects 243 million people globally and is commonly associated with poor sanitation and no access to drinking water. Infections in early childhood may develop into most severe pathologies over years such as hepatosplenomegaly, portal hypertension, and organ failure. Today, there is no adequate treatment for children under the age of six which are estimated to account for 10% of the global population infected or at risk.

Pediatric  Praziquantel  Consortium

The Pediatric Praziquantel Consortium was founded in July 2012. Its ultimate objective is to develop and register a new praziquantel pediatric formulation for the treatment of schistosomiasis in preschool-age children, including infants and toddlers. In this consortium of highly driven partners, Merck, responsible for leading the program, also brings the necessary chemistry and manufacturing expertise, resources, and support related to praziquantel. In addition, it provides the preclinical, clinical and regulatory resources necessary to efficiently and successfully execute the project. Astellas Pharma Inc. contributes by providing its innovative pharmaceutical technologies in the area of drug formulation development and clinical development in children. Swiss TPH brings extensive experience in helminths biological and pharmacological research, epidemiology and clinical research on drug effectiveness and efficiency in endemic regions. The governance is facilitated by TI Pharma, a non-profit organization and independent party with an extensive portfolio of international public-private partnerships in drug research and development, including in the area of neglected diseases. Farmanguinhos, the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, brings unique expertise to produce and distribute the new pediatric formulations product in endemic countries. Simcyp, a small UK research-based company, will build and validate a pharmacokinetic model that will allow a better prediction of the appropriate dosage for use in the pediatric clinical trials.

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 http://www.astellas.com/en  

About  Merck

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 38 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 visit http://www.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 700 staff members from 62 nations are organized in two research and three service departments.

For more information, please visit http://www.swisstph.ch

About  Farmanguinhos

Farmanguinhos is a technical-scientific unit of the Oswaldo Cruz Foundation. Bearing in mind the mission of "Acting with environmental responsibility in promoting public health through the production of medicines, research, technological development and general diffusion of knowledge", this unit is the largest public pharmaceutical company under the Brazil's Ministry of Health and are produced medicines for the treatment of diabetes, hypertension, malaria, AIDS, tuberculosis, among others. Farmanguinhos also has an important role in meeting emergency demands of the Ministry of Health.

For more information, please visit http://www2.far.fiocruz.br/farmanguinhos/  

About  Simcyp

Simcyp Limited was founded in 2001 by Professor Geoff Tucker, Professor Amin Rostami-Hodjegan and Mr. John Evans as a spin-out company from the University of Sheffield, UK. Early in 2012 Simcyp was acquired by Certara, a leading provider of drug discovery and development software and scientific consulting services. Simcyp operates as a stand-alone business unit within the Certara group which also includes Pharsight and Tripos. Simcyp provides platforms for the modeling and simulation of pharmacokinetics and pharmacodynamics in virtual human populations and virtual laboratory animals (rat, dog and mouse). The technology allows pharmaceutical researchers to predict in vivo outcomes from routinely generated in vitro data, to fit Simcyp models to observed clinical data and to assess inter-individual variability through 'real-life' simulations. Simcyp also runs educational workshops, on-site education and provides strategic consultancy in drug development.

For more information, visit http://www.simcyp.com 

About  Top  Institute  Pharma

Top Institute Pharma (TI Pharma), a non-profit organization, enables groundbreaking pharmaceutical research for the development of new medicines by establishing and managing international public-private partnerships. Within an open innovation model, scientists, the business world, patient organizations and others collaborate in frontrunner, multidisciplinary research aimed at improving the development of socially valuable medicines.

For more information, please visit http://www.tipharma.com