On June 1, 2016, Mylan’s partner Theravance BioPharma announced that it had completed the enrollment of around 2,300 human subjects for three Phase 3 clinical trials testing the use of revefenacin for the treatment of chronic obstructive pulmonary disease (or COPD).
According to data collected by Theravance Biopharma, in the United States, ~12.7 million patients have been diagnosed with COPD. It’s believed that a similar number of patients has yet to be diagnosed in the United States. This underlines the market opportunity available for Mylan and Theravance BioPharma’s investigational drug.
Mylan expects to release efficacy data from these trials in 4Q16 and to file an abbreviated new drug application (or ANDA) in 2017. If revefenacin is approved by regulatory bodies as a COPD therapy, it could boost Mylan’s share price as well as the price of the Health Care Select Sector SPDR ETF (XLV). Mylan makes up about 0.78% of XLV’s total portfolio holdings.
The above graph shows that Mylan’s revenue from the sale of its respiratory drugs witnessed a year-over-year (or YoY) rise of around 75.3% and reached $442.2 million in 2015. The company is expected to continue reporting strong revenue growth trends for its respiratory drugs in the future. It’s also expected to become a key player in the respiratory segment, similar to its peers Novartis (NVS) and GlaxoSmithKline (GSK).
Mylan has submitted an abbreviated new drug application (or ANDA) to the FDA seeking approval for the generic version of GlaxoSmithKline’s respiratory drug Advair.
With a Generic Drug User Fee Act date of March 28, 2017, announced for this ANDA, Mylan expects to launch generic Advair in the US market in 2017. Peers Teva Pharmaceuticals (TEVA) and Vectura have also filed applications for FDA approval of their generic versions of Advair.