Company Analysis - Institute for OneWorld health
Social entrepreneurs to the rescue - step in Victoria Hale
Within its first 5 years, OneWorld Health achieved the dream: the approval of a visceral leishmaniasis (VL) drug in India in 2005, less than 3 months after the registration submission and having completed the largest ever trial for the disease...In one of the grandest attempts to rise to the challenge, Victoria Hale's brainchild, the Institute for OneWorld Health, was set up in 2000 and became the US's first not-forprofit pharmaceutical organization. Dr Hale, during her career in the US FDA, recognized the scale of the inequities found in global health policies and strived to disprove big pharma's opinion that 'non-profit drug production would never work'. She had a clear and simple mission to serve as a 'positive agent for change by saving lives, improving health and fulfilling the promise of medicine to those in medical need'.
The company’s strategy is simple and is possibly why success has quickly followed. Hale devised a strategy of finding anti-infective drugs that have already been developed, but have since been discontinued in order to follow other more profitable lines of research. OneWorld Health found that by in-licensing these drugs, and carrying out the necessary tweaking in order to reduce any adverse events and to optimize potency, they could be developed quickly and more cost effectively, so that provision to poorer communities is feasible. In response to this method of drug development and the potential it holds, OneWorld Health has attracted many heavyweight pharmaceutical partners to assist in its non-profit process, with funding mainly provided by the Bill and Melinda Gates Foundation. With such a colourful, motivated and valuable (both intellectually and monetarily) selection of recruits, OneWorld Health has many more tricks up its sleeve than perhaps any other like-minded attempt has had before.
Sensibly, OneWorld Health initially focused on 4 areas: visceral leishmaniasis, malaria, diarrhoeal diseases and Chagas’ disease, and its hard work in these areas has already paid off.
Within its first 5 years, OneWorld Health achieved the dream: the approval of a visceral leishmaniasis (VL) drug in India in 2005, less than 3 months after the registration submission and having completed the largest ever trial for the disease. The Phase III trial demonstrated non-inferiority against amphotericin, with final cure rates of 94.6 and 98.8%, respectively. Cure rates were also high in paediatric patients and in patients where previous treatment had failed (96 and 98%, respectively). Mild injection-site pain was observed in 55% and transient increases in liver function values in 6% of patients. OneWorld’s product promises to be a much cheaper option than the current standard of care therapies, with a shorter regimen of 21 days compared to amphotericin’s 30-day course. The drug, paromomycin, was developed in collaboration with 7 international partners, including the Indian company Gland Pharma, which will manufacture it, and with the Drugs for Neglected Diseases Initiative (DNDi). The off-patent aminoglycoside antibiotic is an established drug, first marketed in 1959. It has an exclusive and well characterized safety profile, and is already used to treat Old World cutaneous leishmaniasis, amoebiasis, cryptosporidosis and giardiasis.
OneWorld’s malaria project has involved a novel approach to the already existing Artemisinin Combination Therapies (ACTs). Artemisinin has been used as a Chinese herbal remedy for thousands of years, and takes over 8 months to cultivate from the wormwood plant. Despite the most commonly used ACT being priced at only US$2.40 per treatment course, it is still financially unattainable to many developing countries. OneWorld Health is targeting these issues by aiming to produce a stable source of microbiallyproduced artemisinin to supplement existing sources. With the reduction in manufacturing costs, prices for the therapy should lower dramatically.
The Bill and Melinda Gates Foundation has also given funding for another therapy for malaria, a disease for which there are a few late stage new chemical entities in development. Immtech Pharmaceuticals, for example, is developing pafuramidine maleate, an amidoxine derivative with US orphan drug status. It is in Phase III trials in countries including Angola, the Democratic Republic of Congo and Sudan, and is also in development for sleeping sickness and Pneumocystis jiroveci infection. Initial data from the first 80 patients has demonstrated good safety and efficacy.
