Shares of Teva Pharmaceutical Industries Ltd. surged on Sunday in Tel Aviv after the drugmaker said on Friday that the US Food and Drug Administration has approved its new treatment for migraines, seen as key to help the troubled drug maker reverse its fortunes.
The approval is seen as a boost to Teva, which hopes the new injection for the preventative treatment of migraine in adults, called Ajovy, will be an alternative source of revenues as it faces stiff competition and a decline in sales for its top selling flagship Copaxone drug for the treatment of multiple sclerosis.
The company’s share price has been battered for most of the past three years, according to data compiled by Reuters, as Teva has struggled to develop new branded drugs along the lines of Copaxone, and as it works to repay debt stemming from its $40 billion acquisition of Actavis Generics, the generics arm of rival Allergan in 2016. Since the acquisition, the generic drugs market has suffered from increased competition and lower prices.
To cut debt, Kåre Schultz, the new president and CEO of Teva, has set out a plan to cut jobs, and close and sell factories. The program has led to a rise in Teva’s share price in the past 12 months.
On Sunday, Teva’s shares surged 7.91% at 10 a.m. in Tel Aviv, bringing the 12-month share price rise to 25%.
Ajovy is a biological drug that uses a humanized monoclonal antibody to block the calcitonin gene-related peptide (CGRP), a protein that is believed to play a role in migraines. The medication is the first and only anti-CGRP treatment for the prevention of migraine with both quarterly (675 mg) and monthly (225 mg) dosing options, Teva said.
The drug was developed by California-based Labrys Biologics Inc, a privately held biotechnology company that Teva decided to acquire in 2014.
Migraine is an unpredictable neurological condition with such symptoms as severe head pain and physical impairment that can impact quality of life and productivity. There are two clinical manifestations of migraine – chronic, where patients suffer 15 or more headache days per month, and episodic, where patients have 14 or fewer headache days per month. Worldwide, approximately 90 percent of people diagnosed with migraine have episodic migraine and 10 percent have chronic migraine.
With more than 1 billion people affected worldwide, migraine is the third most prevalent illness in the world and the 6th most disabling illness in the world. Some 39 million people in the US alone suffer from the condition, according to the Migraine Research foundation.
Sales of the medication could generate some $500 million for Teva by 2022, analyst estimates compiled by Bloomberg show.
“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” said Stephen Silberstein, MD, director, Jefferson Headache Center at Thomas Jefferson University Hospital, and lead investigator of the Phase III clinical trial program for Ajovy, in a statement on Friday. “About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated.”
In clinical trials of Ajovy, patients experienced a reduction in monthly migraine days during a 12-week period.
“With limited availability of preventive treatment options, Ajovy provides physicians with an important new option for their patients,” said Hafrun Fridriksdottir, executive vice president, Global R&D at Teva.
Ajovy will be for sale in pharmacies in the US in about two weeks for $575 per monthly dose and $1,725 per quarterly dose, Teva said.
In May, the FDA approved the drug developed by Amgen for migraine prevention, and it is expected to approve the sale of another migraine therapy medication from Eli Lilly & Co. sometime next month, so competition is expected to be tough.