Pediatric Praziquantel Consortium Expands Into Brazil

            Pediatric Praziquantel Consortium Expands Into Brazil

  PR Newswire

  LEIDEN, The Netherlands, March 26, 2014

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

For more information, please visit 

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

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

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 

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 

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 

Contact: Top Institute Pharma (TI Pharma) Hiliana Fienieg +31 6 526 73 783
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