New Cure for Deadly Visceral Leishmaniasis (Kala-Azar) Approved by Government of India; Institute for OneWorld Health and Gland Pharma Limited Achieve Critical Paromomycin Milestone.

SAN FRANCISCO & NEW DELHI, India -- The Institute for OneWorld Health, a nonprofit pharmaceutical company that develops medicines for neglected diseases of the developing world, today announced that the Drug-Controller General of India (DCGI) has approved Paromomycin Intramuscular (IM) Injection for the treatment of Visceral Leishmaniasis (VL), the second most deadly parasitic disease in the world following malaria.

DCGI's approval of Paromomycin IM Injection came less than three months after the submission of the drug's application, which was prepared by OneWorld Health in collaboration with the Hyderabad-based drug manufacturer Gland Pharma Limited. The application was based on data from a large Phase III multi-center, randomized and controlled clinical trial of 667 adult and pediatric patients conducted in Bihar State, India, which showed that nearly all patients (94.6%) treated with Paromomycin were cured of VL.

A 21-day course of the drug provides a safe, affordable, and effective cure for VL, locally known as kala-azar. A full course of treatment stimulates a specific, cell-mediated immune response, resulting in life-long protection from future infection. The drug is expected be a key tool for India's National Vector Borne Disease Control Programme (NVBDCP), which aims to rid the country of VL by 2010, and disease control programs in other VL-endemic countries. The approval of Paromomycin IM Injection is a major milestone in global health, providing a lifelong cure for a deadly parasitic disease.

"With this approval, the Institute for OneWorld Health, with the vital support of our partners, has proven that it is possible to develop new medicines using an entrepreneurial, non-profit model," said OneWorld Health Founder and CEO Victoria G. Hale, Ph.D. "We are pleased that the first drug in our portfolio will be an important public health tool to help the Indian government safely and affordably control VL."

Gland Pharma will make the medicine available at-cost, or approximately $10 per lifetime cure, a significantly lower price than currently approved VL therapies. Since VL afflicts many people in remote villages and regions that lack a strong health care infrastructure, OneWorld Health will initiate a Phase IV pilot access program in Bihar to facilitate the introduction of Paromomycin IM Injection in these settings. To support its work with partners in India, OneWorld Health will open a Liaison Office in New Delhi and a program office in Patna, Bihar.

"We are proud to have partnered with OneWorld Health to help meet the critical need for new treatments for kala-azar," said Dr. Ravi Penmetsa, Managing Director of Gland Pharma Limited. "This partnership is an innovative way for our company to use its expertise and corporate philanthropy to benefit India. With our combined resources, we are confident that we will make Paromomycin IM Injection available in India and save the lives of people afflicted with kala-azar."

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. The Bill & Melinda Gates Foundation provided funding for clinical testing of Paromomycin.

"This is an important milestone in the fight against Visceral Leishmaniasis, and it demonstrates the potential for public-private partnerships to develop new solutions to serious global health problems," said Dr. Regina Rabinovich, Program Director of the Gates Foundation's Infectious Diseases Program.

About the Institute for OneWorld Health

The Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company, develops safe, effective and affordable medicines for people with neglected diseases of the developing world. The Institute for OneWorld Health, headquartered in San Francisco, USA, is a tax-exempt 501(c) (3) U.S. corporation. (http://www.oneworldhealth.org/). Media resources are available at http://www.oneworldhealth.org/media/index.php/.

About Gland Pharma Limited

Gland Pharma Limited, based in Hyderabad, India, is a pioneer manufacturer of small volume parenterals and the first in India to make pre-filled syringes; it has WHO-GMP, ISO & US Food and Drug Administration (FDA) accreditations and also produces drugs for U.S. distribution.

About Paromomycin Phase III Clinical Trial 

The approval of Paromomycin IM Injection in India is based on data from a large Phase III multi-center, randomized, controlled study of 667 adult and pediatric patients conducted in Bihar State, India over a 17-month period from June 2003 until November 2004. The clinical trial demonstrated that Paromomycin Injection had comparable safety and efficacy to Amphotericin B, a current hospital-based VL therapy. The results of the clinical study showed that nearly all patients (94.6%) treated with Paromomycin Injection were cured of VL. The most common adverse reaction among patients treated with Paromomycin Injection was mild pain at the injection site. Serious adverse events occurred in 4/500 Paromomycin treated patients (0.8%). In early 2005, OneWorld Health received Orphan Drug Designation from the U.S. FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) for paromomycin to treat VL.

About VL

VL is a systemic infection caused by various species of Leishmania parasites; the infection is transmitted by sandflies and causes chronic fever, weight loss, splenomegaly, hepatomegaly and anemia. Left untreated, VL is nearly always fatal. VL currently occurs in 62 countries, primarily in the developing world. Of the approximately 500,000 new cases of VL occurring annually, 90% are found in just five countries: India, Bangladesh, Nepal, Sudan and Brazil. The most affected state in India is Bihar, but VL is also endemic in Jharkand, West Bengal and Uttar Pradesh.