A Message from the Founder & CEO
We did it! On August 31, the Government of India approved our first drug, Paromomycin IM Injection, to cure Visceral Leishmaniasis (VL).

Approval of this drug represents a critically important milestone for OneWorld Health. It proves that a nonprofit pharmaceutical company can successfully develop, and be granted, approval of an important new medicine.

This is a thrilling moment for the many people who have worked long and hard to make it happen. For the people we serve—people suffering from diseases that for far too long have been neglected because they are so poor—the approval of Paromomycin IM Injection means that lives that would have been lost can now be saved. In South Asia, if we use Paromomycin IM Injection wisely, the drug could even eliminate the terrible scourge of VL.

We developed intimate relationships in India. I remain in awe of our revered partners who conducted the clinical trials. We shared a professional intimacy, acknowledging our urgency and passion as signs we were worthy of tackling the problem. With new cases of VL diagnosed daily, how could we not dream of saving as many as we can?

In the broadest sense, the approval of Paromomycin IM Injection validates both our mission and model: to develop safe, effective, and affordable medicines for people with neglected diseases in the developing world. The development of Paromomycin IM Injection to fight VL was made possible by a unique collaboration among OneWorld Health, Gland Pharma Limited, the International Dispensary Association (IDA), IDA Solutions, the World Health Organization’s Special Programme for Research and Training in Tropical Diseases (WHO/TDR) and the Government of India.

Approval from the Drug Controller General of India came less than three months after we submitted the drug’s application in collaboration with Gland Pharma Limited, the India-based drug manufacturer and OneWorld Health partner that will produce the drug. Approval was based on results from a large randomized controlled study we conducted with the help of many dedicated physicians and researchers in India and WHO/TDR. Of course a new drug must be safe and effective. But for the diseases we target, it must also be inexpensive. Gland Pharma will make the medicine available at cost—approximately $10 per life-time cure. That’s a fraction of the cost of other drugs used to treat VL, several of which have serious side effects that limit their use.

Our work is just beginning. Kala-azar is a disease of rural poverty. Western pharmaceutical companies can market their drugs. We have to find other innovative ways to make sure Paromomycin IM Injection reaches the people who need it. To do that, we’re working closely with colleagues from all sectors in India to develop the model and the network that can meet that need.

At the same time, we’re already turning our attention to new challenges. We’re exploring the possibility of developing drugs that will treat diarrheal diseases, which kill millions around the world every year, most of them young children. We’re also in the early stages of developing an inexpensive way to manufacture a promising drug to fight malaria. And we’re continuously evaluating other technologies that may prove effective against other neglected diseases.

Because we did it with Paromomycin IM Injection, we’ve proved to ourselves--and to the world--that we can do it again. And we are ready to do it again.

So please celebrate with us and join us. After years of being mired in pessimism and hopelessness, the field of global health is experiencing a surge of renewed hope, thanks in large part to the extraordinary leadership of the Bill & Melinda Gates Foundation. By celebrating our own success, I hope we can inspire many others like you to join this world-changing crusade. If we’ve proved anything, it’s that with a few good ideas, a strong dose of determination, and the hard work of many dedicated people, we can ease suffering and save lives around the world.

The Institute for OneWorld Health depends on the generous support of individuals all over the world to fulfill our mission. Thank you for supporting our work and helping us develop and provide access to safe, effective, and affordable medicines for people with neglected diseases in the developing world. Please consider going to our website now, www.oneworldhealth.org, and making a contribution, or calling us at 415-421-4700 for further information.

Read the recent New York Times article about the Institute for OneWorld Health and Visceral Leishmaniasis.

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