A laconic report by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) to the Securities and Exchange Commission in the US represents good news for its competitor Mylan: a further delay in the launch of Teva's generic version of Mylan's most important ethical drug, EpiPen (epinephrine).
Teva's notice states: "Teva received a complete response letter on February 23, 2016 relating to its epinephrine ANDA in which the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major nature of the CRL, Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017."
EpiPen came to Mylan through the acquisition of the generics arm of German company Merck KGaA in 2007. The drug is an injection for treating severe allergies. In 2014, sales of EpiPen surpassed the $1 billion mark for the first time, and 2015 sales were also above that level. Mylan's total sales in 2015 were $9.4 billion. Mylan recently raised the price of EpiPen by 14.9%, which contributed to the rise in its sales revenue last year. Mylan also benefitted from the fact that Sanofi's rival drug Auvi-Q was recently removed from the shelves by Sanofi itself because of quality problems.
Teva had previously announced an expected delay in launching its generic version of EpiPen, but estimated that its product would reach the market by mid-2016. Mylan, on the other hand, estimated that Teva might not be able to enter the market in 2016 at all.
Teva commented, "Teva received a complete response letter on February 23, 2016 relating to its epinephrine ANDA in which the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major nature of the CRL, Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017. With regards to guidance, there is no impact on both the short- and long-term."
Published by Globes [online], Israel business news - www.globes-online.com - on March 1, 2016
© Copyright of Globes Publisher Itonut (1983) Ltd. 2016