by Natalie Morrison

LONDON, 3 Aug (APM) - Teva expects to obtain U.S. approval of its migraine prevention drug fremanezumab in mid-September, despite the active ingredient manufacturer Celltrion undergoing a reinspection linked to a prior warning letter, Teva’s chief executive Kåre Schultz said.

The U.S. Food and Drug Administration (FDA) earlier this year refused to approve two of Teva’s biosimilars (APMMA 57574) - of Roche's Rituxan (rituximab) and Herceptin (trastuzumab) - after Korean partner Celltrion’s manufacturing plant received a warning letter over "multiple poor aseptic practices" (APMMA 56859).

In a second quarter results call with analysts on Thursday, Schultz noted that Celltrion is also the manufacturer for the active ingredient in fremanezumab, and that it has undergone a combined preapproval inspection as well as a “reinspection on the warning letter”.

He noted that the inspection was completed in July and that Teva is “expecting still to have approval of the product mid-September”, according to Seeking Alpha’s transcript of the call.

“In terms of the inspection at Celltrion, I can't really give you any specifics on it, and it's not because we are in any extraordinary dialogue with the FDA,” he went on to tell analysts. “We're in the normal dialogue that you have approaching your PDUFA date, but we're still optimistic of achieving the approval on the PDUFA date mid-September.”

“Based on getting an approval, we will be ready to launch immediately thereafter,” he said.

It has been a rocky road for fremanezumab’s development.

The anticipated FDA decision in September for the drug as a quarterly or monthly injection to prevent migraine was pushed back once by three months (APMMA 58221). Teva did not cite the exact reason at the time, noting only that the FDA had made no additional data requests.

The drug was also under development in a Phase III trial for cluster headaches, but Teva ditched the programme in June on lack of efficacy (APMMA 58540).

It is hoped that European authorisation in the migraine prevention indication can be gained in the first half of 2019, Schultz added, noting it would be launched in “selected markets” within the region “all based on the different reimbursement procedures”.

Competitive space

Sanford C. Bernstein & Co analyst Ronnie Gal pointed out that fremanezumab would be the “second or third entrant” to the market with a migraine drug.

Teva’s fremanezumab is one of a new class of migraine prevention drugs known as calcitonin gene-related peptide (CGRP), like Novartis/ Amgen’s Aimovig (erenumab) and Eli Lilly’s galcanezumab.

Aimovig is now approved in the U.S. (APMMA 58141) and in Europe (APMMA 59132), while Lilly’s galcanezumab has been under review at the FDA since December (APMMA 55990), meaning a decision is due imminently.

Gal noted that Amgen is “going very hard” in its pursuit of gaining market share for Aimovig by “giving the product for free for a while”.

“I think what you will have to do as the second or third entrant is essentially to do the same in order not to fall behind on share before the payers begin to narrow their access in 2020- 2021,” he said, asking: “Should we think about the first call it half a year of fremanezumab in the market as essentially being a [time] when you largely are giving the product away in the United States in order to capture significant market share to be competitive when it comes to payers?”

Teva’s head of commercial in North America, Brendan O’Grady, replied: “I don't know that it really matters whether you're second or third to market, because those products will be very close. Most of the payers right now are blocking Amgen's product. So it's difficult to get reimbursement as they're looking at this market to form.”

He added: “We're in conversations with the payers already for 2019. I'm sure Lilly is the same, and obviously Amgen is as well. So I think their six-month period is largely a reflection of when they launched. We launch in late September. If we launch in late September, then I don't think we have quite that long of a runway until the January formulary starts.”

O’Grady added that for all three of the products, there will likely be some kind of free product sampling programme “for a couple of months” so insurance coverage issues can be worked out.

“But we believe that we'll be competitive there. We're confident in the molecule. We think it's a very good molecule. We think we've got a very good package that we've put together.

“We're looking forward to the launch, looking forward to competing, and think this is a really good space to be in.”

nm/clg