Eversheds Sutherland has advised Otsuka on a licensing agreement with global pharmaceutical company Mylan to commercialize Deltyba™ (delamanid) for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries.

Under the terms of the agreement between their respective subsidiaries, Otsuka Novel Products GmbH (ONPG) and Mylan Pharmaceuticals Private Limited (Mylan), Mylan has been granted by Otsuka the exclusive license to prioritize access to Deltyba™ in South Africa and India. Mylan is anticipated to further exercise exclusive commercial rights and registration responsibilities in additional low- and middle-income countries. The agreement also allows both companies to enter into discussions and feasibility studies for a technology transfer plan, allowing Mylan to manufacture and distribute Deltyba™ for these markets in the future.

India and South Africa are considered by the World Health Organization (WHO) as being amongst the highest-burden countries for MDR-TB and TB/HIV co-infection in the world, with over 150,000 estimated new cases of MDR-TB/rifampicin-resistant TB in 2015 alone.

The agreement has significant impact on the healthcare sector in India and South Africa and other high MDR-TB burden countries as with the agreed cooperation both companies seek to jointly fight pulmonary MDR-TB among adults in such countries.

Otsuka is a global healthcare company headquartered in Tokyo, Japan that researches, develops, manufactures and markets innovative products with a focus to meet unmet global medical needs such as TB. Mylan is a global pharmaceutical company with a portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies.

Eversheds Sutherland Munich partner Dr. Tobias Maier comments:

„Advising Otsuka on this strategic transaction shows Eversheds Sutherland’s strong expertise in the life sciences sector and the international coverage and capabilities of our network. We are pleased to have contributed to this important cooperation that will certainly have a sustainable impact on the healthcare sectors in India and South Africa and other low- and middle-income countries.“

Otsuka has been advised by an international team under the overall lead of Munich Partner Dr. Tobias Maier and Associate Magdalena Anna Kotyrba. Further team members were Dr. Christian Mense (Partner, Corporate), Dr. Stefan Diemer (Partner), Christina Söllner (Counsel, both Tax), Steffen Morawietz, Nadine Friese (all Regulatory & IP, Associates, Munich) and Simon Crossley (Partner, Cambridge, UK, Regulatory & IP), Lee O'Connell (Head of Legal and Compliance Consulting, Cardiff, UK), Deon de Beer (Partner, Johannesburg, South Africa, Regulatory & IP), Sameer Sah (Partner, Khaitan & Co, Mumbai, India, Best Friends Firm, Regulatory & IP).

Eversheds Sutherland regularly advises international companies from the pharmaceutical and life sciences industry in all areas of business law. Most recently the German team assisted Horizon Pharma on the acquisition of Raptor Pharmaceutical as well as advised Aspen Pharma on a compliance programme across 20 European countries.