Otsuka Pharmaceutical and Mylan have signed a license agreement to commercialize a pulmonary multidrug-resistant tuberculosis drug, delamanid, between their respective subsidiaries, Otsuka Novel Products and Mylan Pharmaceuticals.

Delamanid was discovered, developed, and is currently marketed by Otsuka under the brand name Deltyba.

Under the agreement, Mylan has been granted an exclusive license by Otsuka to prioritize access to Deltyba in South Africa and India. The Drug Controller General of India granted approval to Mylan to market Deltyba in India, and registration is underway in South Africa.

Mylan is anticipated to further exercise exclusive commercial rights and registration responsibilities in additional countries where Otsuka does not have a commercial presence. The agreement also allows both companies to enter into discussions and feasibility studies for a technology transfer plan, which will enable Mylan to manufacture and distribute Deltyba in the future.

Deltyba is registered in the European Union, Japan, the Republic of Korea, Hong Kong, Turkey, and India. Otsuka recently launched a pre-approval access program in South Africa administered by the Department of Health and a similar rollout program in India is ready to begin.

Source: Mylan