Daxas Approval Delayed – Analyst Blog

Filed in Gold Investing, lead by on May 19, 2010 0 Comments

Forest Laboratories, Inc. ( FRX ) recently announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Daxas (roflumilast). Forest and partner, Nycomed, were looking to get Daxas approved for the treatment of reduction of chronic obstructive pulmonary disease (COPD) exacerbations associated with chronic bronchitis in patients at risk for exacerbations. While the agency has asked Forest and Nycomed to submit additional information and analyses, we are pleased to note that the companies have not been asked to conduct additional studies, which would have involved extra costs and time. The delay in Daxas’ approval does not come as a surprise. Earlier this year, the FDA’s Pulmonary-Allergy Drugs Advisory committee had voted 10-5 against granting approval to Daxas for the treatment of COPD. At that time, concerns were raised regarding the risk-benefit profile of the drug. The FDA had noted that while Daxas achieved statistical significance in clinical studies, the improvements were modest. Moreover, the agency had also expressed concern regarding the safety profile of the candidate. In addition to the frequent and sometimes severe gastrointestinal toxicities observed with the use of PDE4 inhibitors like Daxas, the FDA had raised questions about the occurrence of psychiatric adverse events like suicide. While three people with no previous history of depression committed suicide, two patients who had prior psychiatric histories tried to kill themselves. Forest and Nycomed intend to submit a reply to the complete response letter in the third quarter of calendar year 2010. The delay in Daxas’ approval is a disappointment for Forest given the company’s focus on getting new products approved prior to the loss of patent exclusivity on its lead product Lexapro in 2012. We currently have a Neutral recommendation on Forest. We are concerned about long-term growth at Forest, especially from 2012 when Lexapro is exposed to generic competition. That puts a lot of pressure on the pipeline to come through. With the delay in Daxas’ approval, we believe Forest will intensify its in-licensing and acquisition activities to grow its pipeline. Read the full analyst report on “FRX” Zacks Investment Research

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Daxas Approval Delayed – Analyst Blog

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