Alexza resubmits ADASUVE NDA to U.S. FDA

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012.  ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.  In the coming weeks, Alexza expects to hear from the FDA regarding the completeness of the resubmitted NDA, the classification of the resubmission (Class 1 or Class 2) and what the new Prescription Drug User Fee Act (PDUFA) goal date will be.  Class 1 and Class 2 resubmissions have targeted review periods of 2 months and 6 months, respectively.

ADASUVE NDA Regulatory Update
In May 2012, Alexza received a CRL from the FDA.  In the CRL, the FDA noted, "During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.  Satisfactory resolution of these deficiencies is required before this application may be approved."  Alexza has stated that it believed the deficiencies were medical device specific and readily addressable.  Since the receipt of the CRL, Alexza has received further clarification of the specific deficiencies from the FDA and has made submissions directly to Center for Devices and Radiological Health (CDRH) Office of Compliance and the San Francisco District Office, intended to fully address the deficiencies.

The May 2012 CRL also contained comments on Alexza's draft product labeling.  Alexza believes that there is substantial agreement between Alexza and the FDA on product labeling.  In the ADASUVE NDA resubmission, Alexza has submitted updated draft labeling which is intended to be responsive to the comments provided by FDA in the May 2012 CRL.

There were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL.  With respect to the ADASUVE Risk Evaluation and Mitigation Strategy (REMS), the CRL stated that discussions can continue on the proposed REMS after the response to the CRL has been submitted.  Alexza believes that there is substantial agreement between Alexza and the FDA on the REMS.

ADASUVE MAA Regulatory Update
In March 2012, Alexza received the Committee for Medicinal Products for Human Use Consolidated List of Questions (Day 120 List of Questions) regarding Alexza's ADASUVE Marketing Authorization Application (MAA).  The Day 120 List of Questions included major objections pertaining to the extrapolation of Phase 3 clinical efficacy data, aspects of the risk management plan, and the need to obtain an EU Good Manufacturing Practices certificate for Alexza's Mountain View, CA manufacturing facility and commercial manufacturing process. 

In May 2012, Alexza and its corporate partner, Grupo Ferrer, met with the Rapporteur, Co-Rapporteur and European Medicines Agency (EMA) to further understand specifics of the major objections raised in the Day 120 List of Questions. Alexza believes it remains on schedule for the targeted early third quarter of 2012 submission of its responses (Day 121 Submission) to the EMA.  Also in May, Alexza hosted an EU Pre-Approval Inspection (PAI) by the EMA.  The inspection resulted in no findings the EMA would classify as Critical or Major findings.