Novartis expands partnership with Medicines for Malaria Venture to develop next-generation antimalarial treatment
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Novartis expands partnership with Medicines for Malaria Venture to develop
next-generation antimalarial treatment
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* Novartis will lead the development of antimalarial compound KAF156 with
scientific and financial support from Medicines for Malaria Venture in
collaboration with the Bill & Melinda Gates Foundation
* KAF156 belongs to a novel class of antimalarials that act against both the
blood and liver stages of the parasite's lifecycle
* Antimalarials with new mechanisms of action are urgently needed to tackle
emerging parasite resistance to current therapies
Basel, June 15, 2016 - Novartis announced today that it will further expand its
long-standing partnership with Medicines for Malaria Venture (MMV). Novartis
will lead the development of antimalarial compound KAF156 with scientific and
financial support from MMV in collaboration with the Bill & Melinda Gates
Foundation. This agreement sets out the terms and conditions for the development
of KAF156 and its future availability to patients.
"With a child dying from malaria every two minutes and the threat of drug
resistance growing year-on-year, there is a real urgency to step up global
efforts to combat this disease," said Joseph Jimenez, CEO of Novartis.
"Partnerships and collaborations like this one with MMV are essential for the
development of next generation antimalarials and accelerating efforts to
eradicate this deadly disease."
KAF156 belongs to a novel class of antimalarial molecules and is one of the
first antimalarial drug candidates to enter Phase IIb clinical development in
more than 20 years. It acts against the two parasites responsible for the
majority of malaria deaths (Plasmodium falciparum and Plasmodium vivax) and
against both the blood and liver stages of the parasite's lifecycle. Further, it
has the potential to provide a more convenient dosing regimen and to address the
multidrug resistance that has emerged in five countries of the Great Mekong Sub-
region (GMS). KAF156 builds on the heritage of Novartis in antimalarial drug
development and the launch in 1999 of Coartem(®), the first fixed-dose
Artemisinin-based Combination Therapy (ACT). ACT is the current standard of care
in malaria treatment.
"We are delighted to extend our partnership with Novartis in the development of
this exciting candidate antimalarial medicine with the potential to tackle drug
resistance and improve patient compliance," said Dr. David Reddy, CEO of MMV.
"As such, this agreement marks an important milestone, as MMV continues its
mission to discover, develop and deliver new, effective and affordable
antimalarials to the patients who need them most."
The Novartis Malaria Initiative is committed to drive research, development and
access to novel drugs to eliminate malaria. It is one of the pharmaceutical
industry's largest access-to-medicine programs. Since 2001, the initiative has
delivered more than 750 million treatments without profit, including 300 million
dispersible pediatric treatments, developed by Novartis in collaboration with
MMV, mostly to the public sector of malaria-endemic countries. Although
preventable and treatable, malaria continues to kill a child every two minutes
and threatens the lives of many more.[1] It is caused by parasites transmitted
to people through the bite of infected mosquitoes. A comprehensive range of
interventions is required to eradicate the disease, from bed nets and spraying
for prevention to diagnostics and medicines to treat the disease and block its
transmission.
About the Novartis Malaria Initiative
The Novartis Malaria Initiative is focused on conducting research and
development for the next generation of antimalarials, improving access to
treatment and helping communities deliver better healthcare. Operated by Sandoz,
the Novartis generics and biosimilars division, the Malaria Initiative is one of
the pharmaceutical industry's largest access-to-medicine programs. Since 2001,
the initiative has delivered more than 750 million treatments without profit,
including 300 million dispersible pediatric treatments, mostly to the public
sector of malaria-endemic countries.
Novartis has a long heritage in antimalarial drug development. Coartem(®), the
first fixed-dose Artemisinin-based Combination Therapy (ACT), was launched in
1999. ACT is the current standard of care in malaria treatment. Currently, there
are two potential antimalarial therapies in Phase II clinical trials in the
Novartis portfolio, KAE609 (cipargamin)[2] and KAF156. Both are new classes of
compounds that treat malaria in different ways from current therapies, and could
help combat growing resistance to existing artemisinin-based combination
therapies.
About MMV
MMV is a leading product development partnership (PDP) in the field of
antimalarial drug research and development. Its mission is to reduce the burden
of malaria in disease-endemic countries by discovering, developing and
delivering new, effective and affordable antimalarial drugs.
Since its foundation in 1999, MMV and partners have built the largest portfolio
of antimalarial R&D and access projects ever assembled, and brought forward six
new medicines that are already saving lives. MMV's success is based on its
extensive partnership network of over 400 pharmaceutical, academic and endemic-
country partners in more than 55 countries.
MMV's vision is a world in which innovative medicines will cure and protect the
vulnerable and under-served populations at risk of malaria, and ultimately help
to eradicate this terrible disease.
www.mmv.org
About KAF156
KAF156 belongs to a new class of dual-acting compounds known as
imidazolepiperazines (IZPs) that target the parasite at both the liver and blood
stage of its reproductive cycle. If confirmed in clinical trials, the dual
antimalarial activity of the IZP compounds would give this class promise as a
potential first-line therapy for the prevention and treatment of malaria[3],[4].
KAF156, currently in Phase IIb clinical trials, is the result of a Wellcome
Trust, Medicines for Malaria Venture and Singapore Economic Development Board
supported joint research program with the Novartis Institute for Tropical
Diseases, the Genomics Institute of the Novartis Research Foundation, and the
Swiss Tropical and Public Health Institute. The research program aimed to
discover the next generation of antimalarial drugs. Novartis is developing
KAF156 with scientific and financial support from MMV.
Disclaimer
This press release contains expressed or implied forward-looking statements,
including statements that can be identified by terminology such as "next-
generation," "will," "emerging," "potential," "efforts," "committed," "mission,"
"focused," "currently," "could," "would," or similar expressions. Such forward-
looking statements reflect the current views of the Group regarding future
events, and involve known and unknown risks, uncertainties and other factors
that may cause actual results to be materially different from any future results
expressed or implied by such statements. These expectations could be affected
by, among other things, risks and factors referred to in the Risk Factors
section of Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Novartis is providing the information in this press release
as of this date and does not undertake any obligation to update it in the
future.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis
References
[1] World Health Organization, World Malaria Report 2015:
http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf?ua=1.
Last accessed January 2016.
[2] White NJ, Pukrittayakamee S, Phyo AP, Rueangweerayut R, Nosten F, Jittamala
P, Jeeyapant A, Jain JP, Lefèvre G, Li R, Magnusson B, Diagana TT, Leong FJ.
Spiroindolone KAE609 for falciparum and vivax malaria. New England Journal of
Medicine. 2014 July 31;371(5):403-10.
[3] Leong FJ, Zhao R, Zeng S, Magnusson B, Diagana TT, Pertel P. A first-in-
human randomized, double-blind, placebo-controlled, single- and multiple-
ascending oral dose study of novel Imidazolopiperazine KAF156 to assess its
safety, tolerability, and pharmacokinetics in healthy adult volunteers.
Antimicrob. Agents Chemother. 2014 Nov; 58(11):6437-43.
[4] Kuhen KL, Chatterjee AK, Rottmann M, Gagaring K, Borboa R, Buenviaje J, Chen
Z, Francek C, Wu T, Nagle A, Barnes SW, Plouffe D, Lee MC, Fidock DA, Graumans
W, van de Vegte-Bolmer M, van Gemert GJ, Wirjanata G, Sebayang B, Marfurt J,
Russell B, Suwanarusk R, Price RN, Nosten F, Tungtaeng A, Gettayacamin M,
Sattabongkot J, Taylor J, Walker JR, Tully D, Patra KP, Flannery EL, Vinetz JM,
Renia L, Sauerwein RW, Winzeler EA, Glynne RJ, Diagana TT. 2014 KAF156 is an
antimalarial clinical candidate with potential for use in prophylaxis,
treatment, and prevention of disease transmission. Antimicrob. Agents Chemother.
2014 Sep;58(9):5060-7.
# # #
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