Teva continues to wobble as rival drug receives FDA approval

Only two weeks ago, Teva received approval for its newly-developed migraine drug known as Ajovy, raising hopes of improved financial fortunes.

By EYTAN HALON
Updated: SEPTEMBER 30, 2018 01:29
THE TEVA building in Jerusalem. (photo credit: REUTERS)
THE TEVA building in Jerusalem.
(photo credit: REUTERS)
Shares in Teva Pharmaceutical Industries dropped by 4.4% during trading at Tel Aviv Stock Exchange on Thursday after the US Food and Drug Administration (FDA) approved a third preventive-migraine drug, Emgality, produced by Indianapolis-based rival pharmaceutical company Eli Lilly.
Only two weeks ago, Teva received approval for its newly-developed migraine drug known as Ajovy, raising hopes of improved financial fortunes for the heavily indebted Israeli company. Ajovy could bring in as much as $500 million in sales annually, according to Deutsche Bank estimates.
Whereas the wholesale acquisition cost for Ajovy is $575 per monthly dose, or $1,725 per quarterly dose, patients with commercial insurance are candidates to receive Lilly’s Emgality for up to 12 months free as part of the company’s patient support program. The drug’s monthly list price is an identical $575, or $6,900 annually.
Emgality is the third preventive migraine drug to receive FDA approval this year after Ajovy and Aimovig, the latter manufactured by Amgen and Novartis, and was approved for general sale in the US in May.
According to the American Migraine Foundation, migraine is a condition that impacts more than 36 million men, women and children in the US.
Two last-minute Teva patent infringement lawsuits that aimed to block Lilly from bringing Emgality to the US market were dismissed Thursday by US District Judge Allison Burroughs in Boston ahead of the FDA’s ruling.
Although Teva shares on the New York Stock Exchange (NYSE) rallied slightly on Friday, ending the trading day up by 1.41% at $21.54 per share, their current value represents a significant decrease from last week’s peak of $24.83.
“Lilly’s choice to provide Emgality for up to 12 months free to all eligible patients with commercial insurance underscores our 25-year commitment to recognizing and addressing the need experienced by those with migraine,” said Christi Shaw, president of Lilly Bio-Medicines.
Despite the setback for Teva, the company also announced Thursday the exclusive first-to-file launch of a generic version of Cialis (tadalafil) tablets for the treatment of erectile dysfunction. Today, one in seven generic prescriptions dispensed in the US is a Teva-produced generic treatment.
Teva will have the exclusive right to market the generic version of Cialis, none other than Lilly’s second-highest grossing drug of 2017 with annual US sales of nearly $1.93 billion, for the next six months.
Other generic pharmaceutical makers are reportedly ready to launch similar products following the end of the exclusivity period.
Teva’s financial health has been deteriorating since July 2017, when Dutch-American pharmaceutical company Mylan N.V. cut the wholesale monthly cost of its generic version of Teva’s best-selling multiple sclerosis treatment Copaxone by 60%, from $5,000 to $1,900.
Teva had relied heavily on revenue from sales of Copaxone, priced at $5,800 and accounting for some 20% of sales, since 1996 when the drug was first released into the market.
Despite dwindling profits due to loss of market share, the company announced last month that its debts had fallen from $35 billion to $28.4 billion after new CEO Kåre Schultz implemented a series of debt-cutting measures since taking the reins last year.
In November 2017, Teva announced a new organizational and management structure, combining the company’s generic and specialty drugs divisions, in addition to two research and development groups belonging to the divisions.
One month later, Teva announced it would be cutting 14,000 jobs by the end of 2019, constituting approximately 25% of its global workforce and including 1,700 Israeli employees. The move led to mass protests by Teva’s Israeli workers and a Histadrut labor federation-approved general strike in solidarity with those affected.
Teva’s current NYSE share price is far from its November 2017 low point of $11.23 when Schultz took over, but Teva still remains a long way from returning to its $70.32 peak reached in August 2015.


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