Press Release: Novartis receives FDA approval for Egaten(R) for the treatment of fascioliasis, a neglected tropical disease

Novartis International AG / Novartis receives FDA approval for Egaten(R)

for the treatment of fascioliasis, a neglected tropical disease.

Processed and transmitted by West Corporation. The issuer is solely

responsible for the content of this announcement.

-- Egaten is the only drug approved in the US for the treatment of people

with fascioliasis and is currently the only treatment recommended by the

WHO

-- Fascioliasis, commonly known as liver fluke infestation, is estimated to

infect 2.4 million people globally[1]

-- Novartis has been donating Egaten to the WHO since 2005, helping to treat

around 2 million patients in more than 30 countries

-- FDA approval reinforces the company's commitment to reduce the burden of

neglected tropical diseases including fascioliasis, leprosy and malaria

Basel, Switzerland, February 13, 2019 - Novartis announced today that

the US Food and Drug Administration (FDA) has approved Egaten(R)

(triclabendazole) for the treatment of fascioliasis in patients six

years of age and older. This makes Egaten the only FDA-approved drug for

people with this disease and is expected to facilitate broader access to

this important drug not only in the US, but also in affected countries

worldwide.

"Novartis has a long-standing commitment to addressing global health

challenges and supporting disease elimination efforts, in diseases such

as leprosy, malaria and fascioliasis," said Vas Narasimhan, CEO of

Novartis. "Today's FDA approval of Egaten is another important milestone

that we believe will help further expand access to this one-day

treatment, taking us a step closer toward disease elimination."

Fascioliasis, commonly known as liver fluke infestation, is a neglected

tropical disease that infects 2.4 million people worldwide[1], with an

additional 180 million at risk of infection[2]. It is caused by two

species of parasitic flatworms that can infect humans following

ingestion of larvae in contaminated water or food.

Egaten is currently the only medicine for fascioliasis recommended by

the WHO and is on the WHO Model List of Essential Medicines. It is

supplied by WHO during epidemic outbreaks and for periodic use in

endemic countries. FDA approval of Egaten is expected to facilitate drug

licensing and import to these countries, helping ensure sufficient and

prompt availability of the drug when needed. Fascioliasis is recognized

by the FDA as a neglected tropical disease, triggering the award of a

Priority Review Voucher based upon this approval.

Novartis has been donating Egaten to the WHO since 2005, helping to

treat around 2 million fascioliasis patients in more than 30 countries.

In 2018, we renewed our agreement with the WHO to extend the drug

donation until 2022, expected to reach 300 000 patients per year.

"This FDA decision is welcome news for millions who suffer or are at

risk of fascioliasis and removes a major hurdle in expanding treatment

to countries where it is most needed," said Dr Mwelecela Malecela,

Director of the Department of Control of Neglected Tropical Diseases at

the WHO. "We are thankful to Novartis for their sustained decade-long

commitment in tackling yet another disease of poverty."

The Novartis commitment to neglected tropical diseases

Novartis is a signatory to the London Declaration on Neglected Tropical

Diseases, which aims to control, eliminate or eradicate 10 diseases by

2020. The Novartis Institute for Tropical Diseases, founded in 2001, is

dedicated to finding new medicines to treat neglected diseases. In

addition to malaria, research currently focuses on parasitic diseases

such as cryptosporidiosis (diarrheal disease) and three major

kinetoplastid diseases: human African trypanosomiasis (sleeping

sickness), Chagas disease and leishmaniasis. Building on our experience

in neglected diseases, Novartis also implements programs to target

access to medicine for chronic diseases and, most recently, to address

sickle cell disease in Africa, starting in Ghana.

About fascioliasis

Fascioliasis is caused by two species of parasitic flatworms or

trematodes that mainly affect the liver (Fasciola hepatica or Fasciola

gigantica). Both species can infect humans following ingestion of larvae

in contaminated water or food (mainly raw or undercooked vegetation).

The larvae mature into adult worms in the biliary tract. No continent is

free from fascioliasis; human cases have been reported from more than 70

countries worldwide[1].

Left untreated, fascioliasis can result in considerable pain and

discomfort, leading to poor quality of life and loss of productivity.

The acute phase of the disease is manifested with fever, abdominal pain,

nausea, diarrhea and eosinophilia. The disease later progresses to a

latent phase with less symptoms and ultimately into a chronic or

obstructive phase. In children, fascioliasis can be a serious infection

with high fever, enlarged tender liver, and anemia.

About Novartis

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 800 million people

globally and we are finding innovative ways to expand access to our

latest treatments. About 130,000 people of more than 145 nationalities

work at Novartis around the world. To learn more, visit

www.novartis.com.

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References

[1]

https://www.who.int/neglected_diseases/news/fascioliasis-review-provides-new-perspectives-infection-control/en/

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4568335/

# # #

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

Eric Althoff Katerina Kontzalis

Novartis Global Media Relations Novartis Communications

+41 61 324 7999 (direct) +41 61 324 1631 (direct)

+41 79 593 4202 (mobile) +41 79 797 8393 (Mobile)

eric.althoff@novartis.com katerina.kontzalis@novartis.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

Central North America

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Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188

Media release (PDF): http://hugin.info/134323/R/2234169/879666.pdf

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contained therein.

Source: Novartis International AG via Globenewswire

--- End of Message ---

Novartis International AG

P.O. Box Basel Switzerland

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http://www.novartis.com

(END) Dow Jones Newswires

February 13, 2019 16:23 ET (21:23 GMT)