Big blow for Teva as FDA approves Mylan's generic Copaxone

In a major blow for Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), pharmaceutical rival Mylan N.V. (Nasdaq: MYL; TASE: MYL) reported after close of trade last night that the US Food and Drug Administration (FDA) had approved its generic versions of Copaxone. Mylan said that the FDA had approved its 20 mg. daily injection version of the multiple sclerosis treatment and its 40 mg three times weekly version. Mylan says it can begin marketing imminently.

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Copaxone is Teva's flagship branded drug. Sales reached nearly $2 billion in the first half of 2017 with estimated profits of $1.5 billion.

Copaxone's price has risen 1,002% since it was launched in 1996, and the price of the 40 mg version has risen 30% since it was launched in 2014.

In premarket trading on Wall Street, Teva's share price was down 15.25% at $15.94.

Teva warned that any launch by Mylan of a generic version of Copaxone 40mg prior to final resolution of the pending patent appeals and other patent litigation should be considered an "at-risk" launch, which could subject Mylan to significant damages among other remedies.

"We have planned for the eventual introduction of a generic competitor to glatiramer acetate," said Dr. Yitzhak Peterburg, Teva’s Interim president and CEO. "We remain confident in patient and physician loyalty to Teva’s Copaxone due to its recognized efficacy, safety and tolerability profile, and we will continue to promote and support the product. As we are closing the third quarter, it is too soon to officially comment on any change to our full year business outlook."

Due to the anticipated launch of another generic 20mg glatiramer acetate product and the anticipated launch of a first generic 40mg glatiramer acetate product, Teva’s early assessment of the impact of these launches to its earnings for the fourth quarter ended December 31, 2017 is that it could be affected by at least $0.25 cents per share.

Published by Globes [online], Israel business news - www.globes-online.com - on October 4, 2017