The FDA is asking Teva for more analysis, not further clinical trials.
Credit Suisse believes that the delay in obtaining approval for ethical drug SD-809 will have a moderate negative effect on Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA). Teva announced yesterday that it had received a complete response letter from the US Food and Drug Administration (FDA) to its request for approval of the drug for treatment of chorea-associated Huntington's Disease. The FDA is demanding additional analyses of the drug from Teva, but not further clinical trials. The drug is also being developed for other diseases, including tardive dyskinesia (TD) and Tourette syndrome (TS), and the FDA letter should not affect these applications. Teva CFO Eyal Desheh said, "Obviously, we would have been glad to have received the approval now, but it is not the end of the world. Receiving a letter asking for further analysis is quite common. No new clinical trials are involved, so the clinical trial results are apparently acceptable, and we believe that we can answer all the questions asked. We will send all the answers by the end of the third quarter. After that, it is in the FDA's hands, and I do not want to guess how long it will take."
Credit Suisse predicted an eight to ten month delay in potential approval of the drug for marketing, putting it in the first quarter of 2017. Credit Suisse senior analyst Vamil Divan believes that the drug is an important one in Teva's pipeline, with $3.5 billion in annual sales potential by 2027 in its three different forms (close to the peak sales of Teva flagship drug Copaxone). Teva's market cap is $47.1 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on June 1, 2016
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Teva photo: PR