- London-based Hikma Pharmaceuticals reduced its 2017 full-year revenue guidance, shifting its forecast down from $2.2 billion to between $2.0 and $2.1 billion following the Food and Drug Administration's rejection of its copy of GlaxoSmithKline's Advair Diskus (fluticasone propionate/salmeterol).
- With an approval for the generic drug now off the table for 2017, Hikma lowered its revenue estimate from its generics unit to $670 million, down from a previous mark of $800 million.
- Shares in the generic drugmaker fell on the news, trading lower Monday on the London Stock exchange.
Earlier in May, the Food and Drug Administration rejected Hikma Pharmaceuticals copy of GlaxoSmithKline's flagship blockbuster asthma drug Advair Diskus. Hikma said the FDA had classified its concerns with the application, though this didn't appear to be related to the substitutability of the Hikma's copy.
Complete response letters designated as major typically require 10 months to resolve, according to FDA guidelines.
"This updated guidance reflects changes in the outlook for our Generics business, where we have revised our expectation for the launch timing of our generic version of Advair Diskus and where we are experiencing increased price erosion on our marketed products," Hikma said in a trading update before its annual general meeting.
"This assumes we do not launch our generic version of Advair Diskus in 2017 and reflects the intensifying competitive environment in the U.S."
Despite this, Hikma remains hopeful for a slight improvement in the profitability of the generics business in 2017, as it focuses on portfolio optimization and cost savings. In 2016, Hikma's group revenue was $1.95 billion, a 35% increase on the previous year.
GlaxoSmithKline, which had predicted a 45% drop in sales of Advair if a generic launched this year, now has a quarter or two more of breathing room. In March, the FDA also rejected a copy developed by Mylan, making the prospects of a launch of a substitutable version this year unlikely.