The Bill & Melinda Gates Foundation's India Aids Initiative is learnt to have identified the Indian company Glen Pharma to undertake the manufacturing of paromomycin injectables, a latest cure for AIDS related diarrheal symptom. The Foundation, as part of its grant to the HIV prevention programme in India, would fund the company to the tune of $30 million for the transfer of technology.
Revealing the technology transfer grant from Gates Foundation to the Indian company, Dr N K Ganguly, director general, Indian Council for Medical Research (ICMR) said that the grant would facilitate the company to undertake manufacturing of the drug in the country to supply to the Indian patients and also to the neighbouring countries. The paromomycin technology is likely to be sourced from the US-based OneWorld Health, a non-profit pharmaceutical company, which has already initiated clinical trials of the drug in four institutes in India.
OneWorld Health was negotiating with the International Dispensary Association (IDA), a not-for-profit drug supply agency based in the Netherlands, to manufacture injectables paromomycin in India. Through an Indian manufacturer, OneWorld Health and IDA will supply the needs of the worldwide paromomycin market, in India, Bangladesh, and Nepal. In addition, it may supply the drug to Brazil and countries in the Horn of Africa as well.
Paromomycin is an off-patent amino glycoside antibiotic that was previously approved by the US FDA and is still marketed in the US as an oral formulation to treat intestinal parasites. In June 2003, OneWorld Health initiated the largest phase 3 clinical trial ever performed for VL, treating 667 VL patients in India in collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO/TDR). The clinical trial was to conclude in November 2004 and OneWorld Health will submit an application for approval to the Indian regulatory agency in 2005. However, the informed sources from ICMR said that the final results of the trials are yet to come out.
Paromomycin sulphate is best known for its use as a broad-spectrum amino glycoside antibiotic. First isolated from culturable filtrates of Streptomyces krestomuceticus by Farmitalia Carlo Erba, it was initially named "aminosidine." Injectable aminosidine (Gabbromicina) was marketed worldwide in 1959. At the same time, Parke-Davis developed and marketed the drug "paromomycin" (Humatin) as an oral product worldwide. In 1961, paromomycin was shown to be the same as aminosidine.
The spectrum of activity of paromomycin encompasses most Gram-negative and many Gram-positive bacteria, some protozoa and many cestodes. It is poorly absorbed from the gut, so that oral dosing is restricted to the clearing of susceptible bacteria, protozoa and worms from the intestinal lumen. Administered parenterally, it distributes into extravascular fluid space and is effective for treating infections located in most but not all parts of the body.
In animals, paromomycin is used both parenterally and orally as an antibiotic. For humans, it is marketed as an oral anti-parasitic drug and a topical anti-leishmaniasis agent. Orally, paromomycin is used to treat giardiasis, amebiasis (Entamoeba hystolytica) and cryptosporidiosis (Cryptosporidium parvum). Topically, paromomycin is currently used to treat Old World cutaneous leishmaniasis (Leishmania major, L. tropica, L. aethopica). Injectable paromomycin has been used experimentally to treat visceral leishmaniasis (primarily due to L. donovani).
The board of the Bill & Melinda Gates Foundation's India Aids Initiative announced the disbursal of its first grants in India in 2003. The grants, for up to $67.5 million over five years, were made to seven organizations that will implement significant parts of the initiative's HIV prevention strategy.