Pediatric Praziquantel Consortium Expands Into Brazil

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 http://www.astellas.com/en

About Merck

Merck is a leading pharmaceutical, chemical and life science company with total
revenues of EUR 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

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

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

SOURCE Top Institute Pharma (TI Pharma)

Source: PR Newswire

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