Otsuka Pharmaceutical Co. Ltd. and Mylan N.V. have entered into a license agreement between their respective subsidiaries, Otsuka Novel Products GmbH (ONPG), and Mylan Pharmaceuticals Private Limited, to commercialize delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries. Delamanid was discovered and developed, and is currently marketed by Otsuka under the brand name Deltyba. Under the terms of the agreement, Mylan has been granted an exclusive license by Otsuka to prioritize access to Deltyba in South Africa and India. Both countries are considered by the World Health Organization (WHO) as among the highest-burden countries for MDR-TB and TB/HIV co-infection, with over 150,000 estimated new cases of MDR-TB/rifampicin-resistant TB in 2015 alone.

Mylan is anticipated to further exercise exclusive commercial rights and registration responsibilities in additional countries, including many other high MDR-TB burden 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, enabling Mylan to manufacture and distribute Deltyba for these markets in the future.

Deltyba is one of two anti-tuberculosis medicines recently approved, after more than 40 years of treatment with the same agents. It is registered in the European Union, Japan, the Republic of Korea, Hong Kong, Turkey, and India. Since regulatory approval, more than 4000 treatment courses of Deltyba have been shipped for use in over 50 countries. Otsuka recently launched a novel, preapproval access program in South Africa administered by the Department of Health and a similar rollout program in India is ready to begin.

' We are proud to partner with Otsuka to help deliver this medicine in the highest-burden countries and provide more MDR-TB patients with access to treatment.'

Rajiv Malik

President,

Mylan Pharmaceuticals


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