Japan-based Otsuka Pharmaceutical Co Ltd and global generic and speciality pharmaceutical company Mylan NV (NASDAQ: MYL) have entered into a licence agreement involving their respective subsidiaries, Otsuka Novel Products GmbH (ONPG) and Mylan Pharmaceuticals Private Ltd (Mylan), the two companies announced on Thursday.
Under the agreement the two businesses will commercialise delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries. Previously, delamanid was discovered, developed and marketed by Otsuka under the brand name Deltyba.
Mylan will have an exclusive licence granted by Otsuka to prioritise access to Deltyba in South Africa and India. Both nations are among the highest-burden countries for MDR-TB and TB/HIV co-infections, with more than 150,000 estimated new cases of MDR-TB/rifampicin-resistant TB in 2015 alone, according to the World Health Organization (WHO).
Deltyba is currently one of two recently approved anti-tuberculosis medicines after more than 40 years of treatment utilising the same agents. It has already been approved and registered in the European Union, Japan, the Republic of Korea, Hong Kong, Turkey and India.
Mylan president Rajiv Malik said: "Mylan's mission is to provide access to medicine to the world's 7 billion people, including those in the developing world where the need for medicines like Deltyba are great and the challenges to reaching patients with high quality medicines are high.
"We are proud to partner with Otsuka to help deliver this important medicine in the highest-burden countries and provide more MDR-TB patients with access to treatment."
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