FDA denies Teva Copaxone generic trials petition

Teva is still hoping that generic versions of the multiple sclerosis treatment will be delayed by clinical trials.

In recent years, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has been investing major efforts to delay generic competition to its flagship branded drug Copaxone for the treatment of multiple sclerosis. Alongside legal measures against the companies developing generic Copaxone, that have won some success, Teva is also working through regulatory channels.

Teva has repeatedly petitioned the US Food and Drug Administration (FDA) to rule that marketing for generic Copaxone will not be approved without clinical trials being conducted, because it claims that it is a complicated drug to copy. On the assumption that companies would be compelled to conduct clinical trials, competition would be delayed for two to three years. Teva has submitted a citizen's petition to the FDA four times on this matter.

"Globes" has learned that Teva's fourth petition to the FDA, submitted six months ago, was denied several days ago. This was a technical rejection meaning that the FDA has not necessarily said the last word on this matter.

Sources believe that Teva had expected a negative response from the FDA, as happened on the three previous occasions. After a long detailed explanation the FDA wrote, "We are denying your request without comment on the specific requirements for approval of any generic version of Copaxone."

Copaxone's importance to Teva is extremely significant. Sales in the first nine months of 2012 of the injectable treatment reached $2.94 billion, mainly in the US. While sales are expected to fall slightly in 2013 due to competition from new oral drugs, gross profit is 89%-91% and analysts believe that Copaxone accounts for 45%-60% of Teva's profits.

In Teva's latest petition to the FDA a new claims was introduced claiming that Teva is a colloidal substance, a chemical mixture with specific properties and thus competitors must prove bioequivalence and that absorption into the body of patients is similar to the branded version.

Published by Globes [online], Israel business news - www.globes-online.com - on December 5, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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