Mylan surges, Teva slumps after FDA okays Copaxone copy

The approval late on Tuesday by the U.S. Food and Drug Administration came earlier than both companies had expected. It was issued a day after the health regulator said it would introduce a slew of measures to speed to market generic versions of complex drugs like Copaxone in an effort to address the rising cost of pharmaceuticals.    Copaxone is the leading MS therapy worldwide as well as Teva’s best selling drug. It generated more than $4 billion in revenue for the Israeli drugmaker last year.    With the company facing new competition, Teva’s U.S.-listed shares sank 14 percent to $16.11.    Teva said that Mylan was launching the drug before resolving various patent appeals, meaning Mylan may risk having to pay damages if those appeals favor Teva.    The FDA approved two different doses of Mylan’s version of the drug - 20 mg and 40 mg. But the 40 mg dosage is the important approval, as this dosage accounted for more than 85 percent of the drug’s prescriptions in the second quarter.    Analysts called the approval a big win for Mylan, which has been working to launch a version of the drug for years, and said it would help 2017 and 2018 earnings. The company had originally targeted a 2013 launch.    Wells Fargo analyst David Maris said that, optimistically, the drug could add 13 cents a share to Mylan’s quarterly earnings going forward. That assumes that Mylan is able to capture a 40 percent share of the 40 mg dosage market at a 40 percent discount to Teva’s pricing.    Mylan had lowered its 2017 and 2018 earnings forecast in August, saying that delays in getting FDA approvals for key generics like its versions of Copaxone and asthma treatment Advair would hurt its bottom  line. It said then that it did not expect any major product launches - including Copaxone - until 2018.