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US regulator approves Teva migraine drug, shares rise
[TEL AVIV] Shares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 per cent in after-hours trading on Friday after the US Food and Drug Administration (FDA) approved sales of the company's new migraine treatment, a key drug Teva has been banking on to help revive its fortunes.
The wholesale price of the drug, Ajovy, is US$575 a month - the same as Aimovig, a similar injected migraine treatment sold by Amgen Inc and Novartis AG that has been available in the United States since May.
Teva's drug can also be given in three-month intervals - in three consecutive injections - an option priced at US$1,725.
Teva, the world's largest generic drugmaker had hoped to receive approval for the new drug, known generically as fremanezumab, by June.
Its release was delayed due to US regulatory concerns about the manufacturing process at the South Korean plant of its development partner Celltrion.
Around 39 million Americans suffer from migraine headaches, according to the Migraine Research Foundation, making for a large market that has attracted several drugmakers.
Eli Lilly & Co is also developing a migraine treatment in the same new class of drugs, with the FDA expected to take action by Sept 27.
Demand for Aimovig has been strong, buoyed in part by Amgen programs giving patients two months of free samples followed by up to a year's supply of the drug for those having trouble with insurance coverage. Analysts, on average, have forecast annual Aimovig sales of nearly US$1 billion by 2022, according to Thomson Reuters data.
Teva said it will also offer an assistance program for commercially insured patients, bringing their out-of-pocket costs to as little as US$0.
While Teva has an enormous portfolio of generic medicines, it has long been dependent on its top-selling branded multiple sclerosis drug Copaxone, now facing generic competition, which accounted for about 20 per cent of total sales.
Ajovy is seen as crucial for Teva's recovery.
Shares of Teva, which rose 2.9 per cent to close at US$22.85 in regular trading, were up another 5.4 per cent at US$24 after hours.
The company's share price has been in freefall for most of the past three years, losing about two-thirds of its value as Teva struggled to bring new drugs to market and became saddled by debt from a US$40.5 billion purchase of Allergan's generic drug business in 2016.
In a bid to lower debt, Teva is in the process of cutting more than a quarter of its workforce and closing or selling 10 of its factories. Teva said last month its net debt had fallen to US$28.4 billion from a peak of US$35 billion.
In addition to the migraine drug, Teva is banking on Austedo, an experimental Huntington's disease treatment, to help it return to growth.