Teva reports positive Phase III migraine trial
If everything goes as planned, the drug will be launched in the US in the second half of 2018. The market is competitive, but large for Teva. Citigroup yesterday estimated that peak sales of the drug would exceed $2 billion, although the company noted that Teva was submitting its BLA five months after a BLA submitted by Amgen and Novartis for a competing drug.
"This is a significant milestone for migraine sufferers," said Teva global R&D president and CSO Dr. Michael Hayden. "There have been few innovative treatments for migraine patients in the past 25 years. If Fremanezumab is approved, it will be among the first in a new cycle of migraine prevention drugs to enter the market. We're very proud about the progress that we have achieved in the Fremanezumab development program, and have great expectations for the potential of making this treatment available to millions of people all over the world who are living with the restrictive effects of migraines." Fremanezumab (previously called TEV-48125) came to Teva as part of its acquisition of Labrys in 2014 - the first acquisition led by former CEO Erez Vigodman.
August, following the company's downwardly revised guidance, its major write-off of goodwill in its second quarter financial statements, and a cut in the company dividend.
After Teva's share had already begun to recover from its early September low, following the appointment of Kare Schultz as CEO, Mylan N.V. (Nasdaq: MYL; TASE: MYL) reported two weeks ago that it had obtained marketing approval for its generic version of Copaxone, putting Teva's share price into another tailspin. Teva's market cap is now $15 billion.