Media Update • Media Update • Media Update
Submitted by Novartis
Novartis and the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, have signed a collaboration and licence agreement to jointly develop LXE408, as a potential new oral treatment for visceral leishmaniasis, one of the world’s leading parasitic killers.
LXE408 is a first-in-class compound, discovered at Novartis with financial support from the Wellcome Trust. Within the scope of the agreement, Novartis is responsible for completing Phase I clinical trials. In addition, it will drive pharmaceutical development and regulatory submissions. Upon approval, Novartis has committed to distributing the drug on an affordable basis worldwide with a focus on maximizing access in endemic countries.
DNDi will lead Phase II and Phase III clinical development, with the first Phase II study scheduled to start in early 2021 in India. Additional trials are planned to take place in East Africa, which has the highest burden of visceral leishmaniasis.
“Existing treatments for visceral leishmaniasis are simply not good enough. They are too long, increasingly ineffective, and can be toxic, painful, and costly,” said Dr Bernard Pécoul, Executive Director of DNDi. “Our hope is to radically transform this by developing new oral drugs that are affordable, safe, effective, easy to take, and can also be adapted to meet the treatment needs of patients in different countries.”
Over one billion people worldwide are at risk of leishmaniasis, which is transmitted by the bite of a sand fly. Visceral leishmaniasis, also known as kala-azar, is the most serious form of leishmaniasis, causing fever, weight loss, spleen and liver enlargement, and if left untreated, death. There are an estimated 50 000 to 90 000 new cases per year. Treating the disease is complex as it is dependent on the species of infecting parasite and the country, as treatment responses differ from region to region.
“Novartis has a long-term commitment to neglected tropical diseases that spans several decades. Diseases caused by kinetoplastid parasites, such as leishmaniasis, are one of our strategic research priorities and, together with our partners, we have developed a promising portfolio of drug candidates,” said Dr Lutz Hegemann, Chief Operating Officer for Global Health at Novartis. “We are excited to collaborate with DNDi to reimagine treatment options for people with leishmaniasis around the world.”
The collaboration between DNDi and Novartis is aligned with a broader program with the Wellcome Trust and other partners to develop new combinations of entirely new, all-orally acting chemical entities, to treat visceral leishmaniasis and cutaneous leishmaniasis, another form of the disease.
The program brings together a strong consortium of R&D partners, including the University of Dundee, GSK, Pfizer, TB Alliance, and Takeda Pharmaceutical Company Limited. These partners have built a portfolio of lead series, pre-clinical and clinical drug candidates, originating from different chemical classes with different mechanisms of action against leishmania parasites.
“We are delighted to be partnering with Novartis from drug development to delivering a promising new oral treatment for visceral leishmaniasis. Together, we can contribute to sustaining elimination efforts in India and altering the treatment landscape in East Africa,” said Dr Fabiana Alves, Head of Visceral Leishmaniasis Clinical Program at DNDi.
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products or regarding the collaboration described in this media update. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the collaboration described in this media update will achieve any of its intended goals and objectives in the expected time frame, or at all. Nor can there be any guarantee that such products will be successful in the future. In particular, our expectations regarding such products and the collaboration described in this media update could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality, data integrity, or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at www.novartis.com
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact firstname.lastname@example.org
A not-for-profit research and development organization, DNDi works to develop new treatments for people living with neglected diseases, notably Chagas disease, sleeping sickness (human African trypanosomiasis), leishmaniasis, filarial infections, mycetoma, pediatric HIV, and hepatitis C. Since its inception in 2003, DNDi has delivered eight new treatments, including new drug combinations for kala-azar, two fixed-dose antimalarials, and DNDi’s first successfully developed new chemical entity, fexinidazole, approved in 2018 for the treatment of both stages of sleeping sickness.
# # #
Novartis Media Relations
Novartis External Communications
+41 61 324 1374Call: +41 61 324 1374 (direct)
Novartis US External Communications
+1 646 438 4335Call: +1 646 438 4335
Global Health & CR Communications
+41 61 324 1631Call: +41 61 324 1631 (direct)
+41 79 797 8393Call: +41 79 797 8393 (mobile)
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
|Samir Shah||+41 61 324 7944||Sloan Simpson||+1 862 778 5052|
+41 61 324 1065
+41 61 324 8425
+41 61 324 7188
|Cory Twining||+1 862 778 3258|
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 and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit www.novartis.com.
More from Novartis