A recent licensing agreement allows Mylan to commercialise Otsuka Novel Products’ Delamanid (Deltyba) product indicated for pulmonary multidrug-resistant tuberculosis (MDR-TB) in low and middle-income countries such as India and South Africa.
Mylan hopes to expand the commercial rights and registration into other high MDR-TB burden countries where Otsuka has not had commercial presence.
Figure 1 shows the current number of drugs in pipeline development for MDR-TB. It shows there are very few in last-stage clinical trials and there is an opportunity for more companies to invest in this area.
Figure 1: Novel Drugs in Pipeline for Multidrug-Resistant Tuberculosis
Source: GlobalData, Pharma Intelligence Center, Deals Database [Accessed August, 2017]
South Africa and India are considered by the World Health Organization (WHO) as the highest burden countries for MDR-TB. Since 2015, Delamanid was added to the WHO’s essential medicines list and received first regulatory approval from the European Medicines Agency (EMA) in 2014. However, from 2005, Otsuka has contributed $450m in funding, and most recently produced an initiative programme for development of MDR-TB to lead the way for therapies on the market.