Markets

Mylan surges as its generic of Teva's Copaxone gets FDA nod

Mylan surges as its generic of Teva's Copaxone gets FDA nod

In a statement, Natco said, "The US Food and Drug Administration (FDA) has approved its marketing partner Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection".

The FDA greenlighted Mylan's copy of the Israeli drugmaker's long-acting, 40-mg version of blockbuster Copaxone-the market's first-as well as a version of the 20-mg original, the generics giant said.

On Monday, the U.S. FDA announced a series of measures created to speed to market generic versions of complex drugs such as Mylan's emergency EpiPen, in an effort to address the rising cost of pharmaceuticals.

Teva, based in Israel, saw its USA listed shares drop 15% following the announcement by the FDA, while Mylan became the top gainer for the S&P 500 prior to the market opening Wednesday.

Both dosages have been approved for sale by Mylan.

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"Approval represents a meaningful positive for Mylan", JPMorgan analysts said in a note, adding it should push 2017 and 2018 earnings per share higher.

Up to Tuesday's close, the stock had risen 36.9 per cent this year.

Shares of Teva Pharmaceuticals, which makes the branded version of Copaxone, fell by 11% on Wednesdsay, while Mylan, which makes the new generic version, was up as much as 18%.

One analyst on Wall Street said this news adds to what was already a challenging short term setup for Teva, with the businesses generic segment in the USA under heavy pressure, very high levels of leverage, as well as limited clarity for drivers of a wide ranging recovery in its results. It's considered a "complex generic drug" by FDA Commissioner Scott Gottlieb.


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