Welcome!

News Feed Item

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  


SOURCE Top Institute Pharma (TI Pharma)

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vice president of product management, IoT solutions at GlobalSign, will teach IoT developers how t...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, will discuss how leveraging the Industrial Interne...
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
Redis is not only the fastest database, but it has become the most popular among the new wave of applications running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 18th Cloud Expo, Dave Nielsen, Developer Relations at Redis Labs, will shares the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, will show how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningfu...
Many private cloud projects were built to deliver self-service access to development and test resources. While those clouds delivered faster access to resources, they lacked visibility, control and security needed for production deployments. In their session at 18th Cloud Expo, Steve Anderson, Product Manager at BMC Software, and Rick Lefort, Principal Technical Marketing Consultant at BMC Software, will discuss how a cloud designed for production operations not only helps accelerate developer...
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...