by David Kavanagh

A promising tuberculosis drug that has had approval for usage for over 2 years and could effectively treat over 300000 newly infected people has only been utilized in 180 cases, according to medical humanitarian organisation Médecins Sans Frontières (MSF).

In a statement released last week, the group criticised Japanese pharmaceutical company Otsuka for overpricing its experimental drug delamanid and not doing enough to ensure the most vulnerable have access.

Tuberculosis (TB) is one the world’s deadliest diseases, killing an estimated three people per minute and infecting approximately one third of the global population. It is also the leading killer of people diagnosed with HIV.

As one of only two TB drug treatments developed and made available in the past 50 years, the other being Johnson and Johnson’s bedaquiline, delamanid is said to be potent against some of the most lethal strains of the disease, including multidrug-resistant TB and extensively drug-resistant TB.

Otsuka currently provides the drug, which has to be taken alongside other costly medicines, to a handful of countries for US$1700 per treatment course.

TB advisor for MSF’s Access Campaign Dr Grania Brigden said most governments, especially those in the developing world, deem this pricing unaffordable.

Furthermore, Otsuka has to date registered the drug in only four countries, including Germany, Japan, South Korea, and the UK, all of which house a very low number of drug-resistant TB cases.

“Otsuka should prioritise expanding access for people whose lives could be saved by delamanid,” said Dr Bridgen

“The price for delamanid needs to come down to an affordable level, and Otsuka should also register delamanid quickly in all countries where the drug has been tested… [and] in countries with the highest burdens of drug-resistant TB.”

Surprised by MSF’s criticisms, Communications director for Otsuka’s global TB program Marc Destito said Otsuka needed MSF, which has been treating multidrug-resistant TB since 1999, to work alongside it in order to improve the situation.

“The price of delamanid was mutually agreed with the Global Drug Facility (GDF) and is the lowest price that we can offer to cover our high manufacturing costs,” he said.

“We are trying to create a sustainable business model to try to entice more companies to get involved in the neglected disease area.

“We are actively working to register delamanid in high-burden countries including Russia, India, China and South Africa but there are many regulatory hurdles to overcome.

“Some countries are not part of GDF, others do not allow special importation of drugs and some lack the regulatory capacity to deal with the processes.”

Last week, Otsuka signed a deal with the Stop TB Partnership, an international body that aims to coordinate various actors in the fight against TB, and cited a desire to increase access to low and middle-income countries.

A public-private partnership between the two groups would include a variety of services designed to assist with the incorporation of delamanid into existing national healthcare programs.

Only countries following relevant WHO guidelines and eligible for financing by the Global Fund to Fight AIDS, TB, and Malaria would be included in this.

MSF’s HIV and TB policy advisor Sharonann Lynch told the Pharma Letter the agreement would mean very little if the drug remained too expensive and inaccessible.

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