Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
December 14, 2017

Otsuka Pharmaceutical Co., Ltd. Receives the Japan Medical R&D Grand Prize for Development of Delamanid, a Drug for Multidrug-resistant Tuberculosis
Japanese Government Grants Award for the First Time

Otsuka Pharmaceutical Co., Ltd. (Otsuka) has been granted the first Japan Medical R&D Grand Prize by the vice director general of the Headquarters for Healthcare Policy in the Cabinet of Japan. The inaugural award was presented to Otsuka for the creation of delamanid at a December 13 ceremony at the prime minister's official residence. At the ceremony, Mr. Toshimitsu Motegi, minister for Healthcare Policy, conferred a certificate of commendation and a commemorative item to the company.

The Japan Medical Research Development Grand Award was established with the aim to enhance public interest and understanding in science by honoring endeavors that have made a significant contribution to the promotion of research and development in the medical field. A second aim is to foster incentives for researchers. A single awardee is recognized annually based on the criteria of "a particularly notable achievement", and the award is second in stature only to the prime minister's award.

Achievement

Otsuka discovered and developed a new drug called delamanid that has demonstrated efficacy against multidrug-resistant Mycobacterium tuberculosis (MDR-TB). MDR-TB has become increasingly difficult to treat using earlier-generation anti-TB drugs. Delamanid has represented an important new treatment option for MDR-TB patients since its first regulatory approval in 2014.

Overview

Infectious diseases account for one-quarter of total deaths worldwide. Among infectious diseases, tuberculosis causes the largest number of deaths. In recent years, the appearance of drug-resistant strains has made treatment even more difficult.

Some of these circumstances were prevalent in 1980, when Otsuka began research on anti-tuberculosis drugs. Decades of efforts, including numerous fruitless starts, culminated in the discovery of delamanid in 2001, a novel compound that demonstrated potent anti-tuberculosis activity. During further testing, delamanid also showed strong efficacy against Mycobacterium tuberculosis strains that were resistant to existing anti-TB drugs.

In April 2014 the European Medicines Agency approved delamanid for use in the EU together with a companion regimen of other anti-TB drugs recommended by the World Health Organization (WHO), in adult patients with pulmonary MDR-TB. Also in 2014, the (WHO) issued an interim policy recommendation for the use of delamanid, and in 2015 the WHO listed delamanid on its Essential Medicines List. The drug is now in use in over 60 countries.

Delamanid was approved for use in Japan in July 2014.

Otsuka continues striving to deliver innovative medicines for patients with unmet medical needs.