The U.S. Food and Drug Administration (FDA) announced recently that it will decide on Endo Health Solutions’ (ENDP - Free Report) candidate Aveed (a long-acting testosterone undecanoate injection) by Feb 28, 2014 (target date). The U.S. regulatory body arrived at the decision after accepting the company’s reply to the complete response letter (CRL) issued by it on Aveed in May 2013.
The response of the company to the CRL satisfied the FDA, which will review the new drug application on the candidate and come to a decision by the assigned target date. Endo Health is looking to get Aveed approved as a treatment for male hypogonadism.
We remind investors that the FDA had issued the CRL on Aveed as it was apprehensive about the risks and complications which may emanate after injecting the drug. While issuing the CRL, the U.S. regulatory body had asked Endo Health to develop a medication guide. Specifically, the FDA asked Endo Health to ensure that the Risk Evaluation and Mitigation Strategy included the guide in addition to Elements to Assure Safe Use to address the safety issue mentioned above.
We are encouraged by the regulatory update on Aveed. The addition of Aveed to Endo Health’s product portfolio in 2014 will be a positive for the company as some of its products are already facing/will face generic competition.
Endo Health’s second quarter 2013 revenues declined on a year-over-year basis due to lower sales of painkiller Opana ER. Opana ER sales were hurt by generic competition during the quarter.
We note that another painkiller at Endo Health, Lidoderm will be facing generic competition from Actavis, Inc. shortly. In Aug 2012, the FDA had cleared Actavis’ generic version of Lidoderm. However, Actavis’ agreement with Endo Health prohibits the former from selling the drug before Sep 15, 2013.
Endo Health carries a Zacks Rank # 3 (Hold). Companies such as Gilead Sciences Inc. (GILD - Free Report) and Actelion Ltd. currently appear well placed. Both stocks sport a Zacks Rank #1 (Strong Buy).