Alexza Pharmaceuticals, Inc. (ALXA) recently announced that it has received its EU certificate of Good Manufacturing Practice (:GMP) compliance of a manufacturer. The certificate for GMP compliance was granted to Alexza Pharma’s facility, which manufactures the company’s lead candidate ADASUVE.
We note that in May 2012, an EU GMP inspection was conducted by the Agencia Espanola de Medicamentos y Productos Sanitarios and hosted by Alexza Pharma. The encouraging results of the inspection of the company's facility at Mountain View, Calefornia prompted the Spanish authorities, on the EU’s behalf, to declare that the manufacturing facility complied with the GMP principles and guidelines. The validity of the initial certificate is until May 15, 2015.
Alexza Pharma is looking to get ADASUVE approved in the US for the acute treatment of agitation in adults suffering from schizophrenia or bipolar I disorder. The candidate is currently under review in the US.
We remind investors that Alexza Pharma has been trying hard to get ADASUVE approved in the US since 2009. The company initially submitted a new drug application (:NDA) to the FDA seeking approval of the candidate for the indication in December 2009. The FDA declined to approve the candidate on the basis of the submitted data and issued a complete response letter (CRL) in October 2010. Following meetings with the FDA, Alexza Pharma resubmitted the application in August 2011.
However, Alexza Pharma’s luck regarding ADASUVE did not improve. The FDA issued a second CRL in May 2012. The company re-submitted the NDA in June 2012. A decision from the US Food and Drug Administration (:FDA) is expected by December 21, 2012 (target date). The candidate is also under review in the EU.
We note that the schizophrenia market has big players such as Johnson & Johnson (JNJ). Risperdal Consta, marketed by Johnson & Johnson, is a major player in the market.
We have a Neutral recommendation on Alexza Pharma. Our long-term recommendation is in line with the Zacks #3 Rank (Hold rating) carried by the company in the short run.
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