On June 15, 2006 Gland Pharma Limited and the Institute for OneWorld Health submitted the dossier to the Drug-Controller General of India (DCGI). Paromomycin Intramuscular (IM) Injection was approved on August 31, 2006 for the treatment of Visceral Leishmaniasis (VL). Gland Pharma Limited is the manufacturer of Paromomycin Injection and will distribute the product within India. Sales of Paromomycin Injection will be restricted to use in the National Vector Borne Disease Control Program (NVBDCP). Initially, it will not be available in the private sector, so that its effectiveness can be conserved for VL. iOWH will seek regulatory approval with either the United States Food and Drug Administration (FDA) or the European Union European Medicines Evaluation Agency (EMEA); approval in other VL-endemic countries, such as Bangladesh, Sudan, Brazil and Nepal will then follow.

Partners

Funded by the Bill and Melinda Gates Foundation, OneWorld Health collaborated with IDA, a not-for-profit drug supply agency based in The Netherlands that manufactured paromomycin for the Phase 3 trial (VLPM01) through its subsidiary Pharmamed Parenterals Ltd (PPL) in Malta. The paromomycin API was manufactured by Antibioticos, Italy. IDA had previously manufactured paromomycin for Medecins Sans Frontieres for use in South Sudan. Over time, as promising results emerged from the Phase 3 VLPM01 clinical trial in India, iOWH subsequently collaborated with IDA Solutions (a subsidiary of IDA), a specialized consultancy and project organization dealing with Access to Drugs for Tropical Diseases, also based in the Netherlands. Technology was transferred for production of Paromomycin Injection to Gland Pharma Limited in India. The current Dossier submission by Gland Pharma Limited for regulatory approval of Paromomycin Injection for patients with VL is intended to provided a much needed new, safe and effective therapeutic to combat the epidemic of VL in impoverished regions in and around Bihar state. The current unique public-private partnership with Gland Pharma Limited is expected to supply the needs of the worldwide Paromomycin Injection market for the treatment of VL.

OneWorld Health is also working with the World Bank, WHO and the Government of India to support the country's National Vector Borne Disease Control Programme and its National Plan for Regional Kala Azar Elimination Programme. Medical researchers from key local research centers, such as the Kala Azar Medical Research Centre, the Kalazar Research Centre, and the Rajendra Memorial Research Institute of Medical Sciences and the Institute of Medical Sciences, and facilities in the Ministry of Health system are participating in critical clinical studies. Finally, several NGOs will be key partners on the ground in the Phase 4 study in Bihar state to assess delivery systems, social marketing approaches, and other accessibility and use issues.

Since VL afflicts many people in remote villages and regions that lack a strong health care infrastructure, OneWorld Health will work with its funder, the Bill & Melinda Gates Foundation, and the Indian Council of Medical Research, and Gland Pharma Limited to sponsor a large Phase 4 program to explore and demonstrate the safety and efficacy of paromomycin in progressively more rural conditions in and around Bihar. The paromomycin Phase 4 demonstration program will bring together the government sector (National Vector Borne Disease Control Programme (Dr. H.R. Joshi), ICMR, the Bihar government, other expert non-for-profit organizations and private investigators trained in the program, to administer Paromomycin Injection in a controlled and monitored fashion to large numbers of VL patients and serve as a model of an affordable innovative program dedicated to impoverished patients suffering from VL.

The ultimate goal is to use Paromomycin Injection as a key tool in the National Vector Borne Disease Control Programme to eliminate kala azar from India, and shortly thereafter, Bangladesh and Nepal.

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