Novel Novartis malaria compound shows potential to be effective against infections resistant to all currently available antimalarial drugs

Novartis International AG / Novel Novartis malaria compound shows 
potential to be effective against infections resistant to all currently 
available antimalarial drugs . Processed and transmitted by Nasdaq 
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   -- Results published in the New England Journal of Medicine demonstrate that 
      KAF156 shows activity against blood and liver stages of malaria parasites, 
      including artemisinin-resistant parasites 
 
   -- KAF156, currently in phase IIb, is the first compound from a novel class 
      of antimalarials known as imidazolopiperazines 
 
   -- Antimalarials with new mechanisms of action are urgently needed to tackle 
      emerging parasite resistance to current therapies; Novartis leads two of 
      the four most advanced malaria development programs under way worldwide 
 
 
   Basel, September 21, 2016 - Today Novartis published proof of concept 
study results in the New England Journal of Medicine showing that its 
new antimalarial compound, KAF156, demonstrated activity against both 
vivax and falciparum malaria, including artemisinin-resistant parasites. 
 
   Malaria is a life-threatening disease primarily caused by parasites 
(Plasmodium falciparum and Plasmodium vivax) transmitted to people 
through the bites of infected Anopheles mosquitos. Each year, it kills 
nearly half a million people, most of whom are children[1]. 
Artemisinin-based combination therapies (ACTs), such as Coartem(R), are 
currently the standard of care against falciparum infections. Yet, 
rising resistance to artemisinin and decreasing partner drug efficacy in 
Southeast Asia threatens the global control of Plasmodium falciparum 
malaria. This is why new drugs are needed. 
 
   "KAF156 is a potential game-changing therapy against malaria," said 
Thierry Diagana, Head of the Novartis Institute for Tropical Diseases 
(NITD). "It acts against the two main parasites responsible for the 
majority of malaria deaths and against the blood and liver stages of the 
parasite's lifecycle. Novartis leads two of the four most advanced 
malaria development programs worldwide. If the programs are successful, 
they could help address the emerging issue of multidrug resistance." 
 
   KAF156 is the first compound from a novel class of drugs called 
imidazolopiperazines whose mechanism of action is still being 
characterized, but may be related to a previously uncharacterized gene 
(Plasmodium falciparum cyclic amine resistance locus, Pfcarl). In line 
with WHO guidance that antimalarials be co-formulated to mitigate the 
risk of parasite resistance development, it is expected that KAF156 will 
become part of a combination regimen when used to treat malaria. 
 
   From March to August 2013, a phase II, open-label, two part study was 
conducted in five centers in Thailand and Vietnam to assess KAF156 in 
adult patients with acute uncomplicated P.vivax (11 patients) or 
P.falciparium (10 patients) malaria. Multiple dose (400 mg once daily 
for 3 days) cohorts assessing parasite clearance rates were followed by 
a single dose cohort in falciparum malaria (800 mg) assessing 28 day 
cure rates (22 patients). Researchers saw that KAF156 resolves signs and 
symptoms of illness and cleared parasitemia rapidly in both vivax and 
falciparum malaria patients, including infections with 
artemisinin-resistant parasites. 
 
   "We are currently losing the battle against resistance in the Great 
Mekong Sub-region. In the past resistance has spread from this region 
and caused millions of deaths in Africa and India. The discovery and 
development of new safe and effective antimalarial drugs which are 
unrelated to those we currently use and do not share their resistance 
mechanisms, is essential if we are to curb this threat, and to control 
and ultimately eliminate malaria," said Professor Nick White, from the 
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of 
Tropical Medicine, Mahidol University, Bangkok, Thailand. 
 
   Teams working as part of a 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, 
discovered KAF156.  Research was supported by the Wellcome Trust, the 
Singapore Economic Development Board, and Medicines for Malaria Venture 
(MMV). Novartis will lead the development of KAF156 with scientific and 
financial support from MMV (in collaboration with the Bill & Melinda 
Gates Foundation). 
 
   The research and development of KAF156 is part of a broader commitment 
by Novartis in the fight against malaria. The Novartis Malaria 
Initiative drives research, development and access to novel treatments 
as part of this effort. Operated by Sandoz, the Novartis generics and 
biosimilars division, the Novartis Malaria Initiative is one of the 
pharmaceuticals industry's largest access-to-medicine programs. Since 
2001, the initiative has delivered more than 800 million treatments 
without profit, including over 300 million dispersible pediatric 
treatments, mostly to the public sector of malaria-endemic countries. 
For more information visit www.malaria.novartis.com 
 
   Disclaimer 
 
   The foregoing release contains forward-looking statements that can be 
identified by words such as "potential," "could," "may," "expected," 
"will," "commitment," or similar terms, or by express or implied 
discussions regarding potential marketing approvals for KAF156, or 
regarding potential future revenues from KAF156. You should not place 
undue reliance on these statements. Such forward-looking statements are 
based on the current beliefs and expectations of management regarding 
future events, and are subject to significant known and unknown risks 
and uncertainties. Should one or more of these risks or uncertainties 
materialize, or should underlying assumptions prove incorrect, actual 
results may vary materially from those set forth in the forward-looking 
statements. There can be no guarantee that KAF156 will be submitted or 
approved for sale in any market, or at any particular time. Nor can 
there be any guarantee that KAF156 will be commercially successful in 
the future. In particular, management's expectations regarding KAF156 
could be affected by, among other things, the uncertainties inherent in 
research and development, including unexpected clinical trial results 
and additional analysis of existing clinical data; unexpected regulatory 
actions or delays or government regulation generally; the company's 
ability to obtain or maintain proprietary intellectual property 
protection; general economic and industry conditions; global trends 
toward health care cost containment, including ongoing pricing 
pressures; unexpected safety, quality or manufacturing issues, and other 
risks and factors referred to in 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 any forward-looking statements 
contained in this press release as a result of new information, future 
events or otherwise. 
 
   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. 
 
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   # # # 
 
   References 
 
   1.   http://www.who.int/malaria/mpac/mpac-sept2015-director-update.pdf. 
 
   Novartis Media Relations 
 
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(END) Dow Jones Newswires

September 21, 2016 17:00 ET (21:00 GMT)