Alexza Pharmaceuticals, Inc.
) 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
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
). 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.
ALEXZA PHARMACT (ALXA): Free Stock Analysis
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