Japan's Otsuka eyes MDR-TB drug nod in Indonesia in team with Nipro diagnostic effort

Otsuka Pharmaceutical has applied to sell multidrug-resistant tuberculosis drug Delamanid in Indonesia and join hands with fellow Japanese firm Nipro to ramp up diagnostic efforts, the Nikkei Asian Review reports.

The companies are working with the Japan International Cooperation Agency (JICA) to focus on TB in Indonesia, part of a wider effort by Otsuka on Delamanid that comes from a decades-long effort to develop a treatment that can be used in developing countries for the most resistant strains, though approval in Indonesia could take years, Nikkei said.

Delamanid works with a cocktail of other drugs to block the production of mycolic acid, a key component of the dense, waxy shell that encases the tuberculosis bug and helps it resist penicillin and most antibiotics.

It has won approval from Japan's Pharmaceutical and Medical Devices Agency and in Europe is used under tight controls set by the European Medicines Agency.

But it is not approved in the U.S., where another treatment for multidrug-resistant tuberculosis, Sirturo, by Johnson & Johnson's ($JNJ) Janssen Therapeutics was the first new TB medicine approved of any kind for 40 years.

Johnson & Johnson and Otsuka do not expect to make money on the drugs.

Nipro could start selling its TB detection kits in early 2016, Nikkei said, using the JICA program to reach healthcare professionals and aim for sales of ¥150 million ($1.2 million) by 2020.

Tuberculosis, or TB, is the world's deadliest infectious disease after AIDS, according to the World Health Organization (WHO). But resistant strains are of particular growing concern for patients whose disease no longer responds to isoniazid and rifampicin, two standard therapies.

- here's the story from Nikkei Asian Review