[Ip-health] DNDi and Cipla to Develop 4-in-1 Paediatric Antiretroviral Drug Combination

Rachel Cohen rachel.cohen72 at gmail.com
Fri Jul 20 05:01:32 PDT 2012

DNDi and Cipla to Develop 4-in-1 Paediatric Antiretroviral Drug Combination 

New formulation to fill the deadly gap in appropriate HIV medicines for
infants and young children 


[Washington, DC; Geneva; Mumbai – 20 July 2012] On the eve of the XIX
International AIDS Conference in Washington, DC, the Drugs for Neglected
Diseases initiative (DNDi), a not-for-profit research and development (R&D)
organization, announced a new collaboration with Indian drug manufacturer
Cipla to develop and produce an improved first-line antiretroviral (ARV)
combination therapy specifically adapted to meet the treatment needs of
infants and toddlers living with HIV/AIDS. Once delivered, this new
paediatric ARV combination could help to accelerate the provision of care to
the world’s youngest children living with HIV/AIDS, who are at very high
risk of dying without treatment. An estimated 3.4 million children have
HIV/AIDS, but less than a quarter currently have access to antiretroviral
therapy (ART), compared with 54% for adults. Without treatment, more than
half of children with HIV/AIDS will die before their second birthday, and
80% will die before they turn five. 


Current therapeutic options for HIV-positive infants and young children are
insufficient in certain key circumstances: although fixed-dose combination
dissolvable ‘baby pills’ (for example Triomune Baby and Junior produced by
Cipla in 2007) are used throughout most of Africa, they are not optimal for
the youngest children who have very high levels of virus in their blood and
have already been exposed to some of these drugs from their mother. An
important alternative drug (lopinavir-ritonavir protease inhibitor) has been
used mainly in South Africa, but has problems, including poor taste,
impractical multiple liquid preparations that are cumbersome to transport,
requirements for refrigeration, high cost, difficulties for caregivers to
administer, and negative interactions with tuberculosis (TB) drugs. 


The goal of the collaboration between DNDi and Cipla is to develop a 4-in-1
ARV combination product for HIV-infected children under the age of three
years, including those who have been exposed to drugs while in the womb, and
also those who are co-infected with TB. 


Historically, major pharmaceutical companies have invested little in R&D
specifically aimed at addressing the needs of young children with HIV/AIDS
largely because of the absence of a viable market: the virtual elimination
of mother-to-child transmission of HIV in high-income countries means that
nearly all HIV-positive children live in low- and middle-income countries,
with over 90% in sub-Saharan Africa. The global strategy to eliminate new
infant infections through prevention of mother-to-child transmission (PMTCT)
by 2015 will be confronted with the reality that some children continue to
be infected and urgently need access to early diagnosis and immediate ART
with safe, potent, child-friendly treatment combinations. 


‘Cipla is fully committed to take its ARV work for children with HIV/AIDS a
step further’, said Dr Yusuf K. Hamied, Chairman and Managing Director of
Cipla, Ltd. ‘We have already been working with the Medical Research Council
Clinical Trials Unit (MRC CTU) in the UK and their paediatric colleagues in
Zambia and Uganda for several years, first producing several appropriate
baby pill formulations for infants and children, and more recently we have
produced a new sprinkle of lopinavir-ritonavir. Cipla and DNDi are now
joining forces to produce further drug formulations for HIV-infected
children in poor countries.’ 


Within the new collaboration, Cipla will provide its lopinavir/ritonavir
(LPV/r) 40-/10-mg sprinkle formulation (‘Lopimune Sprinkles’) and work with
DNDi and other partners to test new combinations of HIV treatment for
infants and young children. The initial data on the lopinavir-ritonavir
sprinkle – being generated by Ugandan paediatricians and MRC CTU in
partnership with Cipla (CHAPAS 2 trial) – will be essential for DNDi and its
partners to develop an optimized first-line therapy in a fixed-dose
combination of Lopimune Sprinkles, combined with one of two other powerful
ARV drug combinations, abacavir/lamivudine (ABC/3TC) or
zidovudine/lamivudine (AZT/3TC). Cipla will work to produce an appropriate
4-in-1 combination sachet product, in which the four ARV drugs will be in
taste-masked, granular form, for easy mixing into food or liquids such as
water, juice, or breast milk, with the aim of registering the drug by 2015. 


‘The lack of appropriate treatments for young children with HIV/AIDS has
been devastating’, noted Dr Unni Karunakara, President of MSF International.
‘This initiative responds to our call for attention and resources to be
directed towards giving these kids the medicines, life, and dignity they


As the industrial partner, Cipla will take responsibility for production,
registration, and distribution of the product and will thus retain all
intellectual property (IP) related to the new formulations. Should Cipla opt
out as industrial partner, DNDi will be granted non-exclusive, worldwide,
royalty-free licences to the IP. In addition, the collaboration aims to
bring the cost of the final ARV product in the public sector substantially
lower than the cost of the products used separately. Cipla and DNDi will
establish a detailed drug access and implementation plan to ensure delivery
of the new product to patients.  


‘This partnership with Cipla and other collaborators provides us a critical
path to developing better paediatric antiretroviral formulations for the
youngest, most vulnerable patients living with HIV/AIDS’, said Dr Bernard
Pécoul, Executive Director of DNDi. ‘Young children living with – and dying
from – HIV/AIDS deserve the best that science has to offer. We will
concentrate our every effort to ensure that we get to the right treatment as
soon as possible to save the lives of the over 600 HIV-positive children who
die silently every day.’ 


Media contact 

Oliver Yun, Communications Manager, DNDi North America: Mobile:
+1-646-266-5216 / office: +1-646-616-8681 

email: oyun at dndi.org 

*On site at IAC in Washington, DC, 21-27 July



About DNDi 

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit
research and development organization working to deliver new treatments for
neglected diseases, in particular sleeping sickness (human African
trypanosomiasis), Chagas disease, leishmaniasis, specific helminth
infections (filarial), malaria, and paediatric HIV. DNDi was established in
2003 by Médecins Sans Frontières/Doctors Without Borders (MSF), the Oswaldo
Cruz Foundation (FIOCRUZ) of Brazil, the Indian Council of Medical Research
(ICMR), the Kenya Medical Research Institute (KEMRI), the Ministry of Health
of Malaysia, and the Pasteur Institute of France. The Special Programme for
Research and Training in Tropical Diseases (WHO-TDR) serves as permanent
observer.  Since its inception in 2003, DNDi has delivered six new
treatments for neglected patients: two fixed-dose antimalarials (ASAQ and
ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage
sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM)
combination therapy for visceral leishmaniasis in Africa, a set of
combination therapies for visceral leishmaniasis in Asia, and a paediatric
dosage form of benznidazole for Chagas disease. www.dndi.org 


About Cipla 

Cipla laid foundations for the Indian pharmaceutical industry back in 1935
with the vision to make India self-reliant in healthcare. Over the years
Cipla has emerged as one of the most respected names not just in India but
worldwide. Its state of the art R&D centre has given the country and the
world many firsts. This includes the revolutionary AIDS cocktail for less
than a dollar a day and combination easy to take pills for HIV infected
children. With over 34 manufacturing units across the country, Cipla
manufactures over 2000 products in 65 therapies. With a turnover of over US
$ 1.4 billion, Cipla serves doctors and patients in over 183 countries. It
has earned a name for maintaining one global standard across all its
products and services. Cipla continues to support, improve and save millions
of lives with its high-quality drugs and innovative devices. www.cipla.com 


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