Teva on track to file migraine blockbuster

Teva has said it is on track to file its closely-watched migraine drug, fremanezumab, later this year following positive phase 3 results.

Fremanezumab, formerly known as TEV-48125, is part of a new class of drugs under development by a group of rival pharma companies targeting the calcitonin gene-related peptide (CGRP) ligand.

According to EvaluatePharma, analysts rate fremanezumab highest among this class of drugs, forecasting sales in excess of $1 billion by 2022.

Teva is expecting more phase 3 data from the HALO EM study in episodic migraine in the coming weeks and plans to file the drug with the FDA later this year.

The Israel-based company is undergoing a difficult period as it incorporates a generics business bought from Allergan for $40 billion, under the leadership of interim CEO Yitzhak Peterburg after Erez Vigodman stepped down in February.

Teva is also looking for new sources of revenue as its big branded MS drug Copaxone (glatiramer) faces cheaper generic competitors.

Teva said in the phase 3 HALO study of patients with chronic migraine treated with fremanezumab, patients experienced a statistically significant reduction in the number of monthly headache days of at least moderate severity vs. placebo (-2.5 days) during the 12 week period after first dose, for both monthly and quarterly dosing regimens.

Patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability.

In the 16-week study, 1,130 patients were randomly allocated either the monthly regime of subcutaneous fremanezumab at 675mg at initiation followed by monthly 225 for two months, the quarterly regime of fremanezumab with placebo for two months, or three monthly doses of matching placebo.

Primary efficacy endpoint of the study was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab.

According to Evaluate, Alder’s CGRP inhibitor eptinezumab is expected to almost match Teva’s drug in terms of sales if approved.

Eli Lilly’s galcanezumab is forecast to produce around $484 million in 2022, while Amgen/Novartis’ erenumab will bring in around $475 million.