Teva Pharmaceutical Industries Ltd.'s (TEVA - Get Report) American depository receipts jumped in morning trading on Monday, Sept. 17, following the news late Friday that the company had clinched the U.S. Food and Drug Administration's nod for its migraine drug.
The FDA greenlit Ajovy (fremanezumab-vfrm) injection as a preventive treatment for migraine in adults. It is the second anti-calcitonin gene-related peptide (CGRP) drug approved by the agency to prevent migraines, after Amgen Inc. (AMGN - Get Report) and Novartis AG's (NVS - Get Report) Aimovig in May. CGRP is thought to play a key role in causing migraine headaches.
Teva's ADRs gained 4.6% to $23.89 on Monday morning. They are up 26% year-to-date and have risen 32% over the last 12 months.
"With the approval in hand, Teva now looks positioned to be the second CGRP on the market, behind Amgen's Aimovig and potentially a couple of weeks ahead of [Eli Lilly & Co.'s] galcanezumab, for which action from the FDA is expected by the end of the month," wrote Leerink Partners LLC analyst Ami Fadia in a note over the weekend.
Petach Tikva, Israel-based Teva said Friday that Ajovy will be available in about two weeks. The drug is the first and only anti-CGRP treatment for migraine prevention with quarterly (675 mg) and monthly (225 mg) dosing options.
"Although we only assume minimal financial contribution from Ajovy in 2018, we believe that Teva will need to execute well through the rest of the year in order to reach our [long-term] peak share of 20%," wrote Fadia.
At $575 a month, or $6,900 annually, Ajovy has the same list price as Novartis' Aimovig. Fadia thinks that Teva will have to offer bigger discounts in light of Aimovig's first-mover advantage and Ajovy's initial availability as an injection in a pre-filled syringe only. Aimovig, by comparison, is administered through the SureClick auto-injector device. The launch of an auto-injector for Ajovy is expected in the second half of 2019, Fadia wrote.
The FDA's approval of Ajovy comes as Teva is undergoing a restructuring as it faces challenges including price erosion in its generics business in the U.S.
The company in December unveiled a massive restructuring plan, which includes cutting 14,000 jobs globally over the next two years, aimed at lowering its total cost base by $3 billion by the end of 2019 from $16.1 billion in 2017.
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