Public Release: 

Celgene Global Health and DNDi expand collaboration

Celgene Global Health and DNDi expand collaboration to identify innovative therapies to benefit patients with neglected tropical diseases

Drugs for Neglected Diseases Initiative

Geneva, Switzerland, and Summit, NJ, USA - 24 September 2014 Celgene Global Health (CGH), a division of Celgene Corporation (NASDAQ: CELG), and the Drugs for Neglected Diseases initiative (DNDi) strengthen their collaboration with a four-year Research Collaboration Agreement to identify and optimize new drug candidates for the treatment of neglected tropical diseases (NTDs). Celgene will provide DNDi with new data and resources to accelerate clinical development of new treatments for patients with NTDs.

Since 2011, CGH and DNDi have collaborated on the screening of CGH's compound library for activity against NTDs. Today, they are expanding the collaboration towards the identification and optimization of potential therapeutic candidates for several of the world's most neglected diseases, including, among others, leishmaniasis, sleeping sickness, Chagas disease, river blindness, and elephantiasis.

The Research Collaboration Agreement focuses on the lead optimization stage of research, with CGH providing novel compounds of interest for the targeted diseases and using its target-identification and drug-discovery technology platforms to progress these compounds up to identification of clinical candidates. DNDi will take the lead on hit confirmation and coordinate and conduct hit expansion, hit-to-lead compound work, and subsequent lead optimization work.

"Working with DNDi is a reflection of the potential value that Celgene's Global Health program is creating to address diseases that afflict patients in many of the world's lowest-income settings. We are very pleased to be partnering with DNDi on this effort," said Dr Jerry Zeldis, Chief Executive Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation. "This collaboration accurately reflects Celgene's culture and values."

"We are very pleased to pursue our collaboration with CGH further, to identify new compounds for the treatment of neglected diseases,' says Dr Bernard Pécoul, Executive Director of DNDi. 'The expertise Celgene has developed over the past years with its global health focus will be a great asset to drug discovery for neglected tropical diseases."

The agreement ensures that the result of the joint research will enable DNDi the freedom to operate within the scope of neglected communicable diseases and in all endemic countries without the need to pay royalties or license fees. Celgene has the right of first negotiation to become DNDi's clinical development, manufacture and distribution partner, with commitment to support broad and unencumbered access to patients in need in endemic countries.

About Neglected Tropical Diseases

Neglected diseases are a group of tropical infections that disproportionately affect the world's poor and marginalized populations. According to the World Health Organization (WHO), more than a billion people or one-sixth of the global population suffer from one or more tropical infectious diseases. The partnership between DNDi and Celgene is focused on finding new treatments to address the following diseases:

  • Leishmaniasis occurs in 98 countries, placing 350 million people at risk worldwide. The parasite that leads to infection is called Leishmania and transmitted by sandflies. Leishmaniasis is a poverty-associated disease with several different forms. Visceral leismaniasis, which is fatal without treatment, and cutaneous leishmaniasis are the most common. Existing treatments are difficult to administer, toxic, and costly. Drug resistance also is an increasing problem.

  • Sleeping sickness, or human African trypanosomiasis (HAT), is endemic in 36 African countries and around 60 million people are at risk of being infected. HAT is transmitted by the tsetse fly and is fatal without treatment. Up until 2009, existing treatments for stage 2 of the disease were toxic or difficult to administer. In 2009, DNDi and its partners launched the first new treatment for HAT in 25 years and are currently testing oral-only treatments.

  • Chagas disease is endemic in 21 countries across Latin America and kills more people in the region than any other parasite-borne disease, including malaria. In total, 100 million people are at risk worldwide and patient numbers are growing in non-endemic countries such as the United States, Australia, and Europe. The disease is transmitted by an insect known as the "kissing bug" and, without treatment, is potentially fatal. Current treatments are effective against the acute phase of infection, and while there is increasing evidence of their efficacy against the chronic phase of the disease, broad use of these treatments is limited due to safety and tolerability issues.

  • Filarial diseases include onchocerciasis (river blindness) and lymphatic filariasis (elephantiasis) caused by parasitic worms, which inflict the heaviest socioeconomic burden of all the neglected tropical diseases and affect millions in poverty-stricken areas. Current treatments for these diseases are based on mass drug administration (MDA) of antiparasitic drugs. MDA drugs kill juvenile worms (microfilariae), but not adult worms (macrofilariae). The reproduction cycle is thus not broken, requiring repeated MDAs for up to 15 years.

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About Drugs for Neglected Diseases initiative (DNDi)

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development organization working to deliver new treatments for neglected diseases, in particular sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, specific filarial diseases, paediatric HIV, and malaria. DNDi was established in 2003 by Médecins Sans Frontières/Doctors Without Borders (MSF), Oswaldo Cruz Foundation (FIOCRUZ) from Brazil, Indian Council for Medical Research (ICMR), Kenya Medical Research Institute (KEMRI), Ministry of Health of Malaysia, and Pasteur Institute of France. The Special Programme for Tropical Disease Research (TDR) serves as a permanent observer. Since its inception, DNDi has delivered six new treatments for neglected patients: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease. http://www.dndi.org

About Celgene Global Health (CGH)

Founded in 2009, CGH is a division of Celgene Corporation, focused on delivering medical innovation to healthcare challenges in the developing world. We believe that innovative therapies and healthcare partnerships are essential components to long term progress and prosperity around the globe. CGH is also committed to providing support to enhance the infrastructure and capability of health systems and local medical experts in the developing world to expand access to safe and effective medicines. Our belief is that the most successful approaches will come from public-private partnerships, collaboration with local experts and sharing best practices. For more information, please visit http://www.celgene.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

For more information please contact:

Violaine Dallenbach
DNDi
Press and Communications Manager
vdallenbach@dndi.org
Tel: +41 22 906 92 47

Brian Gill
Celgene Corporation
VP of Global Corporate Communications
bgill@celgene.com
Tel: +1 908 673 9530

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