Progressive Stocks

[MC33]

ALXA

10K http://ih.advfn.com/p.php?pid=nmona&article=51587407

The number of outstanding shares of the Registrant’s common stock as of March 1, 2012 was 116,136,338.

The FDA takes an advisory committee’s advice into consideration as part of its review of an NDA, but is not bound by an advisory committee's recommendations. After reviewing and discussing the ADASUVE data and the FDA proposed REMS, the committee voted on the following additional questions:



Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be effective as a treatment for agitation in patients with schizophrenia or bipolar mania? The resulting vote was: 17/1/0 (yes/no/abstain).


Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be acceptably safe for use as a treatment for agitation in patients with schizophrenia or bipolar mania:


a. When used in conjunction with the REMS proposed by the sponsor? The resulting vote was: 1/17/0 (yes/no/abstain).

b. When used in conjunction with the REMS proposed by the FDA? The resulting vote was: 5/12/1 (yes/no/abstain).


Does the committee conclude that ADASUVE (loxapine) inhalation powder would be acceptably safe for use as a single dose in 24 hours as a treatment for agitation in patients with schizophrenia or bipolar mania when used in conjunction with the REMS proposed by FDA? The resulting vote was: 11/5/2 (yes/no/abstain).

Our Pipeline

Alexza Commercial Rights

ADASUVE Loxapine

Agitation in adults with schizophrenia or bipolar disorder

NDA resubmitted and a scheduled PDUFA date of May 4, 2012.

MAA accepted for assessment by the EMA on October 26, 2011.



Our product candidates not in active development are:


AZ-104 ( Staccato loxapine, low-dose). AZ-104, a lower-dose version of ADASUVE, is designed for the treatment of patients suffering from acute migraine headaches. AZ-104 has completed a Phase 1 clinical trial in healthy subjects and two Phase 2 clinical trials in patients with migraine headaches.


AZ-002 (Staccato alprazolam). AZ-002 has completed a Phase 1 clinical trial in healthy subjects and a Phase 2a proof-of-concept clinical trial in panic disorder patients for the treatment of panic attacks, an indication we are not planning to pursue. However, given the safety profile, the successful and reproducible delivery of alprazolam, and the IV-like pharmacological effect demonstrated to date, we may in the future assess AZ-002 for other possible indications and renewed clinical development.

AZ-003 ( Staccato fentanyl). We have completed and announced positive results from a Phase 1 clinical trial of AZ-003 in opioid-naïve healthy subjects. This product candidate is designed for the treatment of patients with acute pain, including patients with breakthrough cancer pain and postoperative patients with acute pain episodes.


Other than those licensed to Grupo Ferrer for our ADASUVE product and Cypress for our Staccato nicotine product candidate, we have retained all rights to our product candidates and the Staccato system. We intend to capitalize on our internal resources to develop certain product candidates and to identify routes to utilize external resources to develop and commercialize other product candidates.


http://ih.advfn.com/p.php?pid=nmona&article=51528677


On March 5, 2012, Alexza Pharmaceuticals, Inc. (“Alexza”) and Grupo Ferrer Internacional, S.A. (“Ferrer”) entered into an amendment (the “Amendment”) to the Collaboration, License and Supply Agreement (the “Agreement”) dated as of October 5, 2011. Pursuant to the Amendment, Ferrer and Alexza have agreed to eliminate a future potential milestone payment under the Agreement effective upon the purchase of 2,419,355 shares of Alexza common stock by Ferrer in a private placement at a purchase price of $1.24 per share. The purchase of the common stock by Ferrer will be subject to customary closing conditions and is expected to occur not later than March 15, 2012 pursuant to a stock purchase agreement (the “Stock Purchase Agreement”). The Amendment also provides that during 2012 up to an additional $8 million of Alexza common stock may be purchased by Ferrer, upon a request by Alexza and subject to acceptance by Ferrer, in exchange for the elimination of specified additional milestone payments at a price per share that will be a premium to the market price on the date of purchase

http://ih.advfn.com/p.php?pid=nmona&article=51244104

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA), or the Company, today announced that it has priced its previously announced underwritten public offering of 44,000,000 shares of common stock and warrants to purchase 44,000,000 shares of common stock. The common stock and warrants will be issued separately, but will be sold in combination in the offering, with a warrant to purchase one share of common stock for each share of common stock sold. The price to the public for each share and related warrant is $0.50, for an aggregate offering amount of approximately $22 million.