- The Food and Drug Administration should make an approval decision on Teva Pharmaceutical's highly anticipated migraine treatment by Sept. 16, the company announced Wednesday.
- Fremanezumab is a monoclonal antibody that inhibits calcitonin gene-related peptides (CGRPs). Research has shown CGRPs affect vasodilation and sensory nervous system responses, which in turn have made them a prominent target for developers of headache and migraine medicines.
- Teva expected a June 16 target action date for the drug after U.S. regulators accepted its Biologics Licensing Application in December. But manufacturing issues at South Korea-based Celltrion, the sole supplier for fremanezumab's active pharmaceutical ingredient, have caused some delays.
Teva needs fremanezumab. Over the past few years, the Israeli generics giant has run into serious challenges, most significantly pricing pressures in the U.S. generics market and patent expirations for its biggest brand, MS drug Copaxone (glatiramer acetate) — which accounted for around 17% of revenues in 2017.
The effects of those headwinds are becoming more pronounced too. Teva reported $5.1 billion in revenue for the first quarter, down 10% from the same period in 2017. In the states, revenue from Copaxone and generics decreased 40% and 23%, respectively, year-over-year.
Fremanezumab could offer a reprieve, given analysts expect big things out of the burgeoning CGRP class. Clarivate Analytics, for instance, named Amgen and Novartis' recently approved CGRP inhibitor Aimovig (erenumab) as one of its top 12 drugs to watch in 2018. The firm expects Aimovig to fetch $1.17 billion in sales by 2022.
That positive outlook also underscores the competitive hurdles facing Teva's drug. Not only is there Amgen and Novartis to contend with, but Eli Lilly and Alder Biopharmaceuticals also have CGRP inhibitors in late-stage testing for preventative treatment of migraine. And with the recent manufacturing delays, Lilly's offering could make it to market before fremanezumab.
Investment bank Cowen & Co. pointed out as well that Aimovig, fremanezumab and Lilly's galcanezumab have similar efficacy and safety profiles, meaning things like payer preference and modes of administration will be paramount in securing market share.
"It is in this arena that Teva’s fremanazumab may be at a disadvantage," Cowen wrote in a March report. "Both Aimovig and galcanezumab will be supplied in an auto-injector that can be shipped to the patient and self-administered at home."
"Fremanezumab appears to have a more viscous formulation and, while Teva has plans to develop an autoinjector, the first iteration of the product will be supplied in a pre-filled syringe that will most likely be administered by a healthcare provider. The inconvenience of leaving the home for a quarterly injection would likely put fremanezumab at a disadvantage."
Getting fremanezumab onto the market ahead of rivals is therefore even more important for Teva. The new target action date suggests that may still be possible — or, at the very least, that Celltrion is quickly addressing regulatory concerns.
"We do not have any backup source that we have filed with the FDA. So, we are basically assuming and expecting that Celltrion will get in good shape in terms of GMP compliance, and we have no reasons to believe otherwise," Teva CEO Kåre Schultz said during the company's first quarter earnings call in early May.
Notably, the delays offset Teva's use of a Priority Review Voucher, which it paid $150 million to acquire last year.