Teva finally wins approval for migraine drug; gets embroiled in employee suit

By PharmaCompass

2018-09-20

Impressions: 106 Article

The FDA finally approved Teva Pharmaceutical Industries Ltd.’s migraine treatment — Ajovy — which the company has been counting on to lead a turnaround after three difficult years.

For months, FDA’s approval for Teva’s Ajovy had got delayed due to regulatory concerns over the manufacturing process at the South Korean plant of its development partner Celltrion. Ajovy (fremanezumab) was to be approved in June.

Beleaguered Teva has many woes to contend with, including the US$ 40.5 billion misguided debt it took on to purchase Allergan’s generic drug business in 2016. Another woe emanates from the decline in sales of its best-selling drug Copaxone. This multiple sclerosis treatment faced first generic competition last year, and since then its sales have been on the decline.

According to analysts, Ajovy could reach sales of US$ 500 million annually by 2022. Ajovy also marks a feat for its Danish CEO Kare Schultz, who was brought in a year ago to restructure the company, particularly its costs.

Migraine is a large market — around 39 million Americans suffer from migraines, according to the Migraine Research Foundation. And Ajovy comes with an advantage as it needs to be administered only once in three months, in three consecutive injections. In comparison, Aimovig is a migraine treatment marketed by Amgen and Novartis (which has been available in the US since May) that needs to be given monthly.

Eli Lilly and Co is also developing a migraine treatment in the same new class of drugs, with the FDA expected to take action by September 27.

The company plans to start selling the drug in the US at US$ 575 per monthly dose and US$ 1,725 per quarterly dose making the wholesale price for Ajovy the same as Aimovig.

Meanwhile, a US district court found sufficient evidence that Teva’s behavior leading up to the firing of an employee that filed suit against the company violated its own internal policies.

Teva is facing allegations of age-related discrimination, as well as allegations of being anti-American. Allegations of having an anti-American bias are rare.

The case has been filed by Stephen Middlebrooks, who joined Teva’s Pennsylvania office in 2001 and rose on to become the senior director of facility management for a new North American division in late 2014.

But not before his Israeli manager asked him his age—57 at the time—and when he planned to retire, the lawsuit alleges. Two years later, after a string of negative performance reviews that Middlebrooks is now challenging, he was fired. He then decided to sue the company, alleging both age discrimination and anti-American bias.

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