Generic drugmaker Mylan has picked up an FDA approval for its generic version of Teva’s three-times-weekly multiple sclerosis drug Copaxone and says it has launched it straight away.
The long-awaited approval came nine to 12 months earlier than expected, with the effect of driving a surge in Mylan’s share price and a big decline for Teva given the importance Copaxone (glatiramer acetate) has to the Israeli pharma group’s finances.
Copaxone accounts for a little under one fifth of Teva’s turnover – bringing in just under $2bn in the first six months of the year, a decline of 7%. It has avoided the steep declines that usually accompany patent expiries because the company was able to transition patients from a 20mg daily regimen – which saw its first generic competition in the US in 2015 – to the 40mg three-times weekly regimen.
Now, its final defences for the Copaxone franchise have fallen, and Mylan has decided to launch its 40mg version before resolving outstanding patent litigation, which means it could face costly damages if Teva eventually wins in the courts. It’s also entered the 20mg market, picking up an FDA approval for the daily dose version at the same time.
“Mylan has invested tens of millions of dollars over many years to bring this important medicine to market,” said he company’s chief executive Heather Bresch, who thinks the drugmaker could be in line for 180 days of market exclusivity for its generic under the FDA’s first-to-file rules.
Copaxone is the most prescribed MS drug in the US, with the 40mg dose posting sales of around $3.6bn in the 12 months to end-July 2017 and the 20mg formulation making $700m in that period, according to QuintilesIMS data.
The early start of generic competition is another setback for Teva and new CEO Kåre Schultz, who has not taken up his role yet. The pharma group has been hit hard by weak generic pricing in the US and has been cutting staff, manufacturing sites and non-core assets as part of a turnaround plan.
The approval and launch is also big news for Indian company Natco Pharma, which partnered with Mylan on developing the generic and will share profits on sales.
It comes shortly after the FDA said it planned to introduce new measures to accelerate the approval of generics of ‘complex’ drugs, which Commissioner Scott Gottlieb said includes metered dose inhalers used to treat asthma, as well as some costly injectable drugs such as Copaxone.
The moves came as the agency attempts to respond to the rising cost of drugs in the US and increase the speed of generic approvals.