KAE609 shows promise as next generation treatment for malaria

Novartis International AG / KAE609 shows promise as next generation treatment for malaria . Processed and transmitted by Nasdaq OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

KAE609 is the first antimalarial drug candidate with a novel mechanism of action to achieve positive clinical proof-of-concept in over 20 years
 KAE609 was tested in adult patients with uncomplicated malaria and showed a median parasite clearance time of 12 hours, including in patients with resistant infections[1] 
 For more than a decade, Novartis has been a leader in the fight against malaria, setting the current Gold standard for treatment and building one of the strongest malaria pipelines in the industry

            The digital press release with multimedia content can be accessed here:
             
             

Basel, Switzerland, July 30, 2014- Today, Novartis published clinical trial results in the New England Journal of Medicine showing that KAE609 (cipargamin), a novel and potent antimalarial drug candidate, cleared the parasite rapidly in Plasmodium falciparum (P. falciparum) and Plasmodium vivax (P. vivax) uncomplicated malaria patients[1]. Novartis currently has two drug candidates in development. Both KAE609 and KAF156 are new classes of anti-malarial compounds that treat malaria in different ways from current therapies, important to combat emerging drug resistance. Novartis has also identified PI4K as a new drug target with potential to prevent, block and treat malaria.

"Novartis is in the fight against malaria for the long term and we are committed to the continued research and development of new therapies to eventually eliminate the disease," said Joseph Jimenez, CEO of Novartis. "With two compounds and a new drug target currently under investigation, Novartis has one of the strongest malaria pipelines in the industry."

Malaria is a life-threatening disease primarily caused by parasites (P. falciparum and P. vivax) transmitted to people through the bites of infected Anopheles mosquitoes. Each year it kills more than 600,000 people, most of them African children[2].

"KAE609 is a potential game-changing therapy in the fight against malaria," said Thierry Diagana, Head of the Novartis Institute for Tropical Diseases (NITD), which aims to discover novel treatments and prevention methods for major tropical diseases. "Novartis has given KAE609 priority project status because of its unique potential of administering it as a single-dose combination therapy."

In June 2012, 21 patients infected by one of the two main malaria-causing parasite types took part in a proof-of-concept clinical study conducted in Bangkok and Mae Sot near the Thailand/Burma border where resistance to current therapies had been reported. Researchers saw rapid parasite clearance in adult patients (median of 12 hours)[2] with uncomplicated P. vivax or P. falciparum malaria infection including those with resistant parasites. No safety concerns were identified, however the study was too small for any safety conclusions.

"The growing menace of artemisinin resistance threatens our current antimalarial treatments, and therefore our attempts to control and eliminate falciparum malaria," said Nick White, Professor of Tropical Medicine at Mahidol University in Thailand and lead author of the NEJM article. "This is why we are so enthusiastic about KAE609; it is the first new antimalarial drug candidate with a completely novel mechanism of action to reach Phase 2 clinical development in over 20 years."

KAE609, the first compound in the spiroindolone class of treatment, works through a novel mechanism of action that involves inhibition of a P-type cation-transporter ATPase4 (PfATP4), which regulates sodium concentration in the parasite. Because KAE609 also appears to be effective against the sexual forms of the parasite, it could potentially help prevent disease transmission. The clinical trial was done in collaboration with the Wellcome Trust-Mahidol University - Oxford Tropical Medicine Research Programme. Research was supported by the Wellcome Trust, Singapore Economic Development Board, and Medicines for Malaria Venture.

KAE609 represents one of two new classes of antimalarial compounds that Novartis has discovered and published in the last four years.[3],[4] This drug candidate has shown potent in vitro activity against a broad range of parasites that have developed drug resistance against current therapies. KAE609 is currently being planned for Phase 2b trials.

This research is part of a broader commitment by Novartis in the fight against malaria. The Novartis Malaria Initiative focuses on improving access to treatment, helping communities in malaria-endemic countries deliver better healthcare and investing in research and development into the next generation of antimalarials. Over the past decade, the initiative has become one of the largest access-to-medicine programs in the healthcare industry, measured by the number of patients reached annually. In 2013, Novartis passed the mark of supplying 600 million treatments without profit to the public sector in 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 "promise," "next generation," "building," "pipelines," "potential," "aims," "long term," "committed," "eventually," "growing" "potentially," "commitment," or similar terms, or by express or implied discussions regarding potential marketing authorizations  for KAE609 or KAF156, or regarding potential future revenues from KAE609 or 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 KAE609 or KAF156 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that KAE609 or KAF156 will be commercially successful in the future. In particular, management's expectations regarding KAE609 and 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 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, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 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.

References
[1] http://www.nejm.org/doi/full/10.1056/NEJMoa1315860
[2] World Health Organization, http://www.who.int/mediacentre/factsheets/fs094/en/  
[3] Spiroindolones, a Potent Compound Class for the Treatment of Malaria, KAE609, Science, Sept. 2010
[4] Imaging of Plasmodium liver stages to drive next generation antimalarial drug discovery. Science Express, Nov. 17, 2011

# # #

Novartis Media Relations

Central media line : +41 61 324 2200 Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.comMariellen Gallagher
Novartis Institutes for BioMedical Research
+1 617 871 7665 (direct)
+1 617 909 9137 (mobile)
mariellen.gallagher@novartis.com

e-mail: media.relations@novartis.com

For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please contact: journalisthelp@thenewsmarket.com.

Novartis Investor Relations

Central phone: +41 61 324 7944 Samir Shah +41 61 324 7944 North America: Pierre-Michel Bringer +41 61 324 1065 Stephen Rubino +1 862 778 8301 Thomas Hungerbuehler +41 61 324 8425 Susan Donofrio +1 212 830 9257 Isabella Zinck +41 61 324 7188 e-mail: investor.relations@novartis.com e-mail: investor.relations@novartis.com
Media release (PDF)


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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
HUG#1843976

--- End of Message ---

Novartis International AG
P.O. Box Basel Switzerland

WKN: 904278;ISIN: CH0012005267;