LONDON (ShareCast) - (ShareCast News) - US-based generic and speciality pharmaceuticals company Mylan announced on Tuesday that the US Food and Drug Administration (FDA) had approved two doses of its generic equivalent to Teva's drug Copaxone, which generated $1.02bn worth of sales in the second quarter of 2017, used to treat relapsing forms of multiple sclerosis.
Mylan said shipping of its Glatiramer Acetate 40mg/mL for three-times-a-week injection, as well as a 20mg/mL version for once-daily injection, would begin immediately - it also noted the FDA had advised the firm it would possibly be eligible for a 180-day exclusivity period on the drug.

The surprise appeal came less than 24 hours after the FDA announced a series of new measures aimed at increasing to market speeds of generic drug equivalents as part of an effort to battle the rising cost of pharmaceuticals.

"Approval represents a meaningful positive for the story and will substantially derisk/support upside to (Mylan's) 2017 and 2018 earnings per share," analysts at JP Morgan said in a note on Wednesday.

Israeli firm Teva sank 15.2% in premarket trading, continuing what JP Morgan called an "already challenging near-term" as the company's US generic business had already been "under pressure, high levels of leverage, and limited clarity on drivers of a broader recovery in results."

In September, Teva announced that it was seeking other drug makers it could team up with to develop opportunities in its pipeline as it struggled to keep its head above water amid mounting debts and expiring patents.

As of 1500 BST, Mylan had jumped 17.68% to $38.28 per share.

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