It’s starting to feel like Teva $TEVA can’t catch a break. After an incredibly rough series of events that led to massive layoffs, restructuring, and political upheaval, now Teva has quietly signaled to investors that the launch of its CGRP migraine med could be delayed.
Teva’s stock has tumbled nearly 10% in pre-market trading on the news.
Teva’s drug, called fremanezumab (TEV-48125), came up with some impressive Phase III data last fall, with 41% of patients on their CGRP drug seeing their migraine days cut in half, compared to 18% on the placebo. The double blast of data underscores the late-stage race to regulators as some big and small players angle for a slice of the new CGRP migraine market.
But now, fremanezumab may hit a stumbling block. Teva’s partner Celltrion, which manufactures an active ingredient in fremanezumab, received a warning letter from the FDA raising issues over a manufacturing facility in Incheon, South Korea.
The slowdown couldn’t come at a worse time for the company, as rivals Amgen $AMGN and its partner Novartis $NVS were already in the lead to commercialize their own CGRP migraine drug, Aimovig. The FDA has already accepted Amgen’s application for Aimovig — handing the company a PDUFA date of May 17.
The CGRP field is growing hot, with a lineup of developers positioning their own late-stage products for the last leg of the race.
Earlier this year, Eli Lilly $LLY celebrated its Phase III results for galcanezumab, with a consistent 2-day reduction in monthly migraines. And Allergan $AGN has a late-stage program underway for an oral CGRP therapy it in-licensed from Merck in 2015 with a $250 million upfront. Little Alder $ALDR is planning to join the commercial fight with their drug, as well. Then there’s Biohaven $BHVN, which recently in-licensed a similar drug from Bristol-Myers Squibb and scored a very successful IPO earlier this year.
Teva noted the warning letter on a slide for investors, and said the company was “in active dialogue with the FDA in an effort to maintain our priority date for the approval.”
Typically takes 16-18 months to resolve an FDA warning letter, $TEVA says. Company planned to have two API suppliers but the second supplier isn’t ready yet, Schultz says
— Emma Court (@emmarcourt) February 8, 2018
CEO Schultz says $TEVA is hoping to work with FDA on franezumab CGRP application because Celltrion warning letter was for finished products, not API. A second API supplier is in the works but not ready to go. Good news for rival $NVS
— Jessica Merrill (@Jessicaemerrill) February 8, 2018
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 31,600+ biopharma pros who read Endpoints News by email every day.Free Subscription