The first pharmaceutical company operating on a non-profit basis, OneWorld Health, achieved a critical objective late last month after it won approval in India for its lead product, paromomycin IM injection, to treat the parasitic disease visceral leishmaniasis.
This “proves that a non-profit pharmaceutical company can successfully develop, and be granted, approval of an important new medicine,” commented OneWorld’s chief executive Victoria Hale.
Paromomycin was first discovered decades ago, but languished on the shelf because the drug industry could not see a return on any investment in the compound. OneWorld Health secured rights to develop it from the World Health Organisation and with the help of funding from the Bill and Melinda Gates Foundation conducted trials in visceral leishmaniasis – also known as kala azar and black fever – in areas such as India where the disease is prevalent.
“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 visceral leishmaniasis,” according to Hale, a former Genentech executive who set up OneWorld Health in 2001.
OneWorld collaborated on the project with Indian drugmaker Gland Pharma, which will hold the drug license in India and provide it at cost – around $10 for treatment that should result in a cure. Other treatments for black fever cost anything up to 50 times as much and are prone to serious side effects, and remain out of reach for rural dwellers in India whose annual income can be as little as $300 a year.
The disease affects half a million people each year, killing at least 200,000, with the Bihar region of India, Nepal, Bangladesh, Sudan and Brazil the countries worst affected.
With approval out of the way, the challenge will now be to effectively distribute paromomycin IM, a process which will involve forging collaborations with the Indian government and other stakeholders to “develop the model and the network that can meet that need,” according to Hale.
Meanwhile, with the paromomycin success under its belt, OneWorld Health is now turning its attention at childhood diarrhoeal diseases and malaria.