E-DRUG: DNDi and Cipla to Develop 4-in-1 Paediatric Antiretroviral Combination
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[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 worlds 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
deserve.
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@dndi.org
*On site at IAC in Washington, DC, 21-27 July