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
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Detecting internal user threats in the Big Data eco-system is challenging and cumbersome. Many organizations monitor internal usage of the Big Data eco-system using a set of alerts. This is not a scalable process given the increase in the number of alerts with the accelerating growth in data volume and user base. Organizations are increasingly leveraging machine learning to monitor only those data elements that are sensitive and critical, autonomously establish monitoring policies, and to detect...
In his session at 20th Cloud Expo, Mike Johnston, an infrastructure engineer at Supergiant.io, discussed how to use Kubernetes to set up a SaaS infrastructure for your business. Mike Johnston is an infrastructure engineer at Supergiant.io with over 12 years of experience designing, deploying, and maintaining server and workstation infrastructure at all scales. He has experience with brick and mortar data centers as well as cloud providers like Digital Ocean, Amazon Web Services, and Rackspace. H...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Consumers increasingly expect their electronic "things" to be connected to smart phones, tablets and the Internet. When that thing happens to be a medical device, the risks and benefits of connectivity must be carefully weighed. Once the decision is made that connecting the device is beneficial, medical device manufacturers must design their products to maintain patient safety and prevent compromised personal health information in the face of cybersecurity threats. In his session at @ThingsExpo...
SYS-CON Events announced today that Massive Networks will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Massive Networks mission is simple. To help your business operate seamlessly with fast, reliable, and secure internet and network solutions. Improve your customer's experience with outstanding connections to your cloud.
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
Everything run by electricity will eventually be connected to the Internet. Get ahead of the Internet of Things revolution and join Akvelon expert and IoT industry leader, Sergey Grebnov, in his session at @ThingsExpo, for an educational dive into the world of managing your home, workplace and all the devices they contain with the power of machine-based AI and intelligent Bot services for a completely streamlined experience.
Because IoT devices are deployed in mission-critical environments more than ever before, it’s increasingly imperative they be truly smart. IoT sensors simply stockpiling data isn’t useful. IoT must be artificially and naturally intelligent in order to provide more value In his session at @ThingsExpo, John Crupi, Vice President and Engineering System Architect at Greenwave Systems, will discuss how IoT artificial intelligence (AI) can be carried out via edge analytics and machine learning techn...
FinTechs use the cloud to operate at the speed and scale of digital financial activity, but are often hindered by the complexity of managing security and compliance in the cloud. In his session at 20th Cloud Expo, Sesh Murthy, co-founder and CTO of Cloud Raxak, showed how proactive and automated cloud security enables FinTechs to leverage the cloud to achieve their business goals. Through business-driven cloud security, FinTechs can speed time-to-market, diminish risk and costs, maintain continu...
When shopping for a new data processing platform for IoT solutions, many development teams want to be able to test-drive options before making a choice. Yet when evaluating an IoT solution, it’s simply not feasible to do so at scale with physical devices. Building a sensor simulator is the next best choice; however, generating a realistic simulation at very high TPS with ease of configurability is a formidable challenge. When dealing with multiple application or transport protocols, you would be...
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...
SYS-CON Events announced today that Datera, that offers a radically new data management architecture, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Datera is transforming the traditional datacenter model through modern cloud simplicity. The technology industry is at another major inflection point. The rise of mobile, the Internet of Things, data storage and Big...
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...