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The AZ-104 Phase 2b clinical trial is an outpatient, multi-center,randomized, double-blind, single-dose, placebo-controlled study inapproximately 360 patients who have migraines, with or without aura. Threedoses will be evaluated in the clinical trial, placebo and two doses of AZ-104(1.25 and 2.5 mg). The primary efficacy endpoint for the trial is headachepain relief at 2 hours post-dose, using the standard 4-point rating scale(International Headache Society). Secondary efficacy endpoints for the trialinclude pain relief and other symptom assessments at various time points.Safety evaluations will also be made throughout the clinical trial period.
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"We previously announced initial results with AZ-104 in an in-clinicsetting, showing its positive effect treating pain and other key symptoms ofmigraine headache," said Thomas B. King, Alexza President and CEO. "Webelieve the potential value of the non-invasive nature and rapid onset ofpharmacological action provided by our Staccato system is well-suited formigraine pain relief in the outpatient setting. Data from this outpatientclinical trial will guide our future development plans for AZ-104 for thetreatment of migraine headaches."
About Acute Migraine Headaches
According to the National Headache Foundation, approximately 13 millionpeople in the United States have been diagnosed with migraine headaches.Acute migraine headaches occur often, usually one to four times a month. Ofthe estimated 29.5 million migraine sufferers (including diagnosed andundiagnosed sufferers), there are at least two groups of potential patientsfor whom Alexza believes that AZ-104 could be effective and safe in comparisonto triptans, which are the most commonly used class of therapeutics fortreating migraine. Many migraine sufferers who do take triptans have aninsufficient therapeutic response to these medications. In addition,according to the package inserts for triptans, they are contraindicated inpatients with cardiovascular diseases, and should not be given to patientswith risk factors for coronary artery disease (e.g., hypertension, highcholesterol, cigarette smoking).
About AZ-104 (Staccato loxapine)
AZ-104 is the combination of Alexza's proprietary Staccato system withloxapine, a drug belonging to the class of compounds known as dopaminereceptor antagonists. The Staccato system technology is a hand-held,chemically-heated, single dose inhaler designed to generate and deliverexcipient-free drug aerosol for deep lung delivery that results in IV-likepharmacokinetics.
In March 2008, the Company announced positive initial results of anin-clinic, multi-center, randomized, double-blind, single administration,placebo-controlled Phase 2a proof-of-concept clinical trial in 168 migrainepatients with or without aura. Three doses of AZ-104 (1.25, 2.5 and 5 mg)were evaluated against placebo in the clinical trial. Using the 4-pointrating scale, the primary efficacy endpoint was pain-relief at 2 hourspost-administration. AZ-104 met the primary efficacy endpoint of the clinicaltrial for the two highest doses of the drug compared to placebo. Pain reliefwas observed in 76.7% of patients at the 5 mg dose (p=0.02), 79.1% of patientsat the 2.5 mg dose (p=0.01) and 67.4% of patients at the 1.25 mg dose(p=0.18), compared to 51.3% of patients receiving placebo. AZ-104 wasgenerally safe and well tolerated in this patient population.
About Symphony Allegro
In December 2006, Alexza entered into a collaboration with SymphonyCapital LLC, a biotech-focused private equity firm. Under the terms of theagreement, Alexza and Symphony Capital established Symphony Allegro, Inc.,which is providing funding to Alexza to accelerate clinical and other relateddevelopment activities of Staccato loxapine (AZ-004 and AZ-104) and Staccatoalprazolam (AZ-002). Alexza has granted a license to certain intellectualproperty rights for the selected product candidates. Through a purchaseoption, Alexza retains the exclusive right, but not the obligation, to acquire100% of the equity of Symphony Allegro at specified prices during the term ofthe agreement. If Alexza chooses not to exercise the purchase option,Symphony Allegro retains the rights to the product candidates. The purchaseoption expires December 1, 2010.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is an emerging specialty pharmaceutical companyfocused on the development and commercialization of novel, proprietaryproducts for the treatment of acute and intermittent conditions. TheCompany's technology, the Staccato system, vaporizes unformulated drug to forma condensation aerosol that allows rapid systemic drug delivery through deeplung inhalation. The drug is quickly absorbed through the lungs into thebloodstream, providing speed of therapeutic onset that is comparable tointravenous administration, but with greater ease, patient comfort andconvenience.
Alexza has five product candidates in clinical development. Alexza's leadprogram is AZ-004 (Staccato loxapine) that is being developed for the acutetreatment of agitation in schizophrenic or bipolar disorder patients. Alexzahas completed and announced positive initial results from both of its AZ-004Phase 3 clinical trials, and is projecting a New Drug Application submissionin early 2010. The Company has completed an end-of-Phase 2 meeting with theFDA for AZ-001 (Staccato prochlorperazine), and it has advanced AZ-104(Staccato loxapine) into Phase 2b testing, both product candidates beingdeveloped for the acute treatment of migraine headache. Product candidatesthat have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for thetreatment of breakthrough pain, which is partnered with Endo Pharmaceuticalsin North America, and AZ-007 (Staccato zaleplon) for the treatment ofinsomnia. More information, including this and past press releases fromAlexza, is available online at http://www.alexza.com.
Safe Harbor Statement
This press release includes forward-looking statements regarding thedevelopment, therapeutic potential, efficacy and safety of AZ-104. Anystatement describing a product candidate or Alexza's goals, expectations orbeliefs is a forward-looking statement, as defined in the Private SecuritiesLitigation Reform Act of 1995, and should be considered an at-risk statement.Such statements are subject to certain risks and uncertainties, particularlythose inherent in the process of developing and commercializing drugs. TheCompany's forward-looking statements also involve assumptions that, if theyprove incorrect, would cause its results to differ materially from thoseexpressed or implied by such forward-looking statements. These and otherrisks concerning Alexza's business are described in additional detail in theCompany's Annual Report on Form 10-K for the year ended December 31, 2007, andthe Company's other Periodic and Current Reports filed with the Securities andExchange Commission including the risks under the headings: "Failure or delayin commencing or completing clinical trials for our product candidates couldharm our business", "If our product candidates do not meet safety and efficacyendpoints in clinical trials, they will not receive regulatory approval, andwe will be unable to market them." and "We will need substantial additionalcapital in the future. If additional capital is not available, we will have todelay, reduce or cease operations". Forward-looking statements contained inthis announcement are made as of this date, and the Company undertakes noobligation to publicly update any forward-looking statement, whether as aresult of new information, future events or otherwise.
SOURCE Alexza Pharmaceuticals, Inc.
