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
Corporate Solutions. The issuer is solely responsible for the content of
this announcement.
-- 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.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis.
For Novartis multimedia content, please visit
www.novartis.com/news/media-library. For questions about the site or
required registration, please contact: media.relations@novartis.com
# # #
References
1. http://www.who.int/malaria/mpac/mpac-sept2015-director-update.pdf.
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric Althoff Sandra Schlüchter
Novartis Global Media Relations Novartis Institutes for Biomedical Research
+41 61 324 7999 (direct) +41 61 696 6806 (direct)
+41 79 593 4202 (mobile) +41 79 826 0196 (mobile)
eric.althoff@novartis.com sandra.schluechter@novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Sloan Pavsner +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media Release (PDF): http://hugin.info/134323/R/2043735/763046.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Novartis International AG via Globenewswire
--- End of Message ---
Novartis International AG
P.O. Box Basel Switzerland
WKN: 904278;ISIN: CH0012005267;
http://www.novartis.com
(END) Dow Jones Newswires
September 21, 2016 17:00 ET (21:00 GMT)
