Otsuka Pharmaceutical and Mylan N.V. have entered into a license agreement between their respective subsidiaries, Otsuka Novel Products GmbH (ONPG) and Mylan Pharmaceuticals Private Limited (Mylan), 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. The Drug Controller General of India (DCGI) granted approval to Mylan to market Deltyba in India, and registration is under way in South Africa.
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 announced 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.
"Otsuka is a global leader in TB research and development and Mylan is a recognized leader in the provision of high-quality medicines for infectious diseases in many developing countries," said Tatsuo Higuchi, president and representative director. "Given our respective experience in the field, our two companies are well positioned to work together in the fight against MDR-TB."
Mylan president Rajiv Malik commented, "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."
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 4,000 treatment courses of Deltyba have been shipped for use in over 50 countries. Otsuka recently launched a novel, pre-approval access program in South Africa administered by the Department of Health and a similar rollout programme in India is ready to begin.