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Mylan to Launch Generic Copaxone in H2 2013

Mylan to launch generic Copaxone in H2 2013 [Globes, Tel Aviv, Israel]

From Globes (Tel Aviv) (February 22, 2012)

Feb. 22--Mylan Inc. (Nasdaq: MYL) announced yesterday, in its financial report for 2011, that it plans to launch a generic version of Copaxone, Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) intravenous treatment for multiple sclerosis, in the second half of 2013. Mylan added that patent litigation and US Food and Drug Administration (FDA) approval of its drug are pending.

Mylan chairman Robert Coury said, "We expect that 2012 will be yet another year of exciting growth for Mylan, as will 2013, as we remain committed to our adjusted earnings per share target of $2.75. Our confidence comes as a result of the last several years of hard work and execution, while at the same time delivering strong results for the past 16 quarters."

For its part, Teva has tempered its enthusiasm about its oral multiple sclerosis treatment, Laquinimod. In it 20-F financial report for 2011 filing with the US Securities and Exchange Commission (SEC) on Friday, Teva states, "In October 2011, we held a meeting with the US Food and Drug Administration (FDA) to discuss the possibility of filing an NDA (New Drug Application) for Laquinimod. Following the meeting, we believe it would be premature to file an NDA at this time. Further clinical studies of Laquinimod as monotherapy and add-on therapy in patients with relapsing-remitting multiple sclerosis are currently under review."

Copaxone sales totaled $3.57 billion in 2011, 20.7 percent more than in 2010. The increase was apparently due to higher prices. Analysts expect Copaxone sales to peak this year, and then fall as generic versions of the drug and oral treatments for multiple sclerosis reach the market.

Teva's share price rose 1.3 percent in morning trading on the TASE today to NIS 168.20, after rising 1.3 percent on Nasdaq yesterday to $45.24, giving a market cap of $40 billion.


(c)2012 the Globes (Tel Aviv, Israel)

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Posted: February 2012