Regeneron wins temporary restraining order preventing Eylea generic launch
Regeneron (NASDAQ:REGN) won a temporary restraining order that blocks drugmakers including, Mylan Pharmaceuticals/Biocon Biologics, from launching a generic version of its blockbuster eye drug Eylea. Regeneron rose 1.1%.
Chief Judge Thomas S. Kleeh, of the US District Court for the Northern District of West Virginia, granted the TRO on Friday, according to a court filing. The TRO lasts 14 days.
Samsung Bioepis also can't launch a generic version for 14 days.
The TRO provides "14 days of reprieve to better understand the case and determine the extent of `irreparable harm,'" Deutsche Bank analyst James Shin wrote in a note on Friday. "Our expert thinks there is a 70-75% probability REGN is awarded an injunction based on the case as it stands. That said, our takeaway from listening in to today's scheduling meeting is the biosim players essentially wanted Kleeh to rule on their injunctions ASAP so they can move on to appeals."
Regeneron had a mixed ruling in late December over a patent dispute over Eylea. Regeneron sued Viatris in August 2022 and alleged that a biosimilar version of Eylea proposed by a Viatris's Mylan Pharmaceuticals unit infringes patents for the drug, used to treat retinal diseases.
Also in late December Regeneron filed a new lawsuit against South Korean biopharma Samsung Bioepis, alleging that its biosimilar version of eye disease therapy Eylea violated 51 patents of the U.S. company.
Eylea’s US sales of $6.26 billion accounted for 52% of Regeneron’s revenue in 2022, according to data compiled by Bloomberg LP. The drug had US sales of $5.79 billion in 2021.
May 20, 2024
