Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) is waiting for the US Food and Drug Administration's (FDA) ruling this week on the company's Citizen Petition to prevent the launch of generic versions of Copaxone, Teva's brand treatment for multiple sclerosis.
Teva filed the Citizen Petition on December 12, 2010, after previous petitions were twice dismissed on the grounds that they were premature and unfair. This time, Teva hopes for a favorable ruling by the FDA, which will at declare that any generic version of Copaxone must undergo clinical trials. Clinical trials will delay competition to Copaxone for at least two years.
Clal Finance analyst Jonathan Kreizer believes that the FDA will dismiss Teva's Citizen Petition, but that it will again avoid deciding on the core of the issue. "This is the third attempt to block generic Copaxone. The first and second petitions were similar in substance, and the common denominator for their dismissal was that the FDA had not yet set clear criteria to approve or reject a generic version of Copaxone. The present Citizen Petition basically relates to a rather traumatic event for Teva investors: the FDA's decision to approve a generic version of blood thinner Lovenox, which like Copaxone, is non-characteristic. That approval sent Teva's share price down 8.5% (possibly an overreaction in retrospect), because investors concluded that the FDA approval of Lovenox paved the way for generic Copaxone."
Teva's share price fell 0.7% on Nasdaq on Friday to $50.20, giving a market cap of $44.8 billion, and fell 0.5% in morning trading on the TASE today to NIS 169.10.
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