Teva: Migraine med OK by mid-June date unlikely

• Generics giant Teva Pharmaceutical Industries no longer expects to win U.S. approval of its migraine treatment fremanezumab by the June 16 decision date originally set by the Food and Drug Administration.
• Instead, Teva anticipates a later approval and subsequent launch sometime before the end of 2018, following a pre-approval inspection of production facilities used by contract manufacturer Celltrion Inc. to make the CGRP blocker. That inspection is set to occur in the coming months, Teva said Thursday.
• While the delay is a blow to Teva — potentially meaning fremanezumab enters the market behind two competing products instead of one — the disruption doesn’t appear to knock the drugmaker completely off track.

Long underserved, the market for preventative migraine treatments looks set to see several new entrants over the next year. Amgen and Novartis expect to win U.S. approval for their CGRP inhibitor Aimovig (erenumab) sometime this month, and Eli Lilly could also see a nod from the FDA for its similar drug galcanezumab by the fall.

Teva had hoped to come into the market behind Amgen and Novartis, previously securing a June 16 target action date for fremanezumab by using a coveted priority review voucher.

But GMP violations at Celltrion’s manufacturing plant in Incheon, Korea, threw a wrench in Teva’s plans. In a January warning letter, the FDA detailed regulatory lapses which included poor aseptic behavior among others. The regulator later issued a Complete Response Letter to the Korean drugmaker for two biosimilar drug applications, further dimming Teva’s prospects of winning an on-time approval.

Teva’s admission, announced during an earnings presentation on May 3, leave little doubt of fremanezumab’s fate in the near term.

“We do not expect to receive FDA approval on our Biologics License Applications (BLA) for fremanezumab on the mid-June PDUFA date,” the company said in a statement, while noting they remain engaged in “constructive dialogue” with the FDA.

Celltrion is currently Teva’s sole supplier of active pharmaceutical ingredient for fremanezumab, although the drugmaker plans to develop another source of supply.

Despite the delay, Teva’s chances of competing may not be all that damaged over the longer term.

On a recent earnings call, Lilly’s head of Bio-Medicines, Christi Shaw, noted several months might not move the needle much in terms of market share for the rival CGRP drugs.

“In general though three to four months is not a big deal. By the time you get your label and get approved, then you’re talking about access, really it’s not a big difference,” Shaw said. “If you are looking at bigger delay and you have two agents in the marketplace and you are 12 to 18 months later that is a detriment for share.”

While Shaw was discussing galcanezumab, the comments could reflect a market dynamic that allows Teva to bounce back quickly from the disruption for its drug. That’s, of course, if Teva is actually able to secure an FDA nod by the end of the year as it expects.

Elsewhere, Teva reported a better-than-expected first quarter, paying down debt and raising its estimates for free cash flow in 2018. Competition to Teva’s MS drug Copaxone (glatiramer acetate) and falling generics prices still stung, however, leading to a 10% drop in revenues compared to the same period a year ago.

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