FDA offers surprise OK for Mylan’s Copaxone knockoffs, slamming Teva
Heather Bresch, CEO of MylanMylan won its years-long quest to gain an FDA OK for its copycat of Teva’s 40 mg and 20 mg doses of the multiple sclerosis drug Copaxone, triggering a series of stock moves as investors reacted quickly to the unexpected advance.
Mylan had been delayed by information requests from the FDA, which prompted some analysts earlier to write off any possibility of an OK this year. But FDA commissioner Scott Gottlieb has made swifter generic approvals — with the implicit promise of lower drug prices — a top priority at the agency.
Now Teva is facing a serious showdown for its franchise branded drug at a time it’s been hindered by price erosion in its own generic portfolio. The Israeli company has been forced to restructure this year, with a weak pipeline and a key clinical failure for its MS drug successor this year.
Teva’s shares $TEVA dropped 13% this morning.
EvercoreISI’s Umer Raffat readily conceded this morning that he had been wrong about the timing on this. He added that Mylan appears to be putting a lot of muscle into its rollout.
Mylan is instituting a patient support program to ensure that patients don’t have a “hard landing” with no support services when they transition off of Teva’s “Shared Solutions”. Mylan also intends to have copay assistance as well as nursing support. There is clearly some SG&A spend being allocated to this launch on Mylan’s part – not a traditional AB rated generic launch.
Momenta, which has struggled as well in getting its rival into the marketplace, also took a hit — shares $MNTA dropped 25% in early trading.
The big winner was Mylan, which saw its stock $MYL spike 16%.
Said Mylan CEO Heather Bresch:
Mylan has invested tens of millions of dollars over many years to bring this important medicine to market.
