Natco Pharma shares jump 20% as partner Mylan's injections get USFDA approval

The launch plans for both products will be communicated shortly after concurring with its partner Mylan,” Natco said

Mylan NV said the U.S. Food and Drug Administration has approved two doses of its generic version of Teva's Copaxone used to treat patients with relapsing forms of multiple sclerosis.

The FDA on Monday said it would introduce new measures to speed up bringing generic versions of complex drugs to the market.

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.

The FDA approved both doses - 20 mg and 40 mg - of Mylan's version of Teva's Copaxone, which generated global sales of $1.02 billion in the second quarter of 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%.

JPMorgan analysts said the decision added up to full generic competition for Teva 9 to 12 months ahead of previous Wall Street expectations. "The news adds to an already challenging near-term setup for the story, with the company's US generic business under pressure, high levels of leverage, and limited clarity on drivers of a broader recovery in results", JPM added.

Mylan has gained FDA approval for its three-times-a-week 40 mg/mL generic injection - the first to have been given the nod by the U.S. regulator - plus a once-daily 20 mg/mL version, both of which are indicated for the treatment of patients with relapsing MS.

Teva in September said it wanted to partner with other pharmaceuticals to fund part of its development of drugs, as it has struggled with its debts and its expiring patents. And Mylan ran into hurdles with the 40-mg product, too, with the company acknowledging in June that it had received an "information request" from the FDA.



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