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Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. These and other
risks concerning Alexza's business are described in additional detailultramin the
Company's Annual Report on Form 10-K for the year ended , and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission including the risks under the headings. About Alexza Pharmaceuticals, Inc. If Alexza chooses not to exercise the purchase option, Symphony Allegro retains the rights to the product candidates. The Company's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows rapid systemic drug delivery through deep lung inhalation.
Alexza has granted a license to certain intellectual
property rights for the selected product candidates. Safety evaluations will also be made throughout theultramclinical trial period. AZ-104 was
generally safe and well tolerated in this patient population. Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary
products for the treatment ofcheap fioricet onlineacute and intermittent conditions. ALXA) announced today that it has initiated a Phase 2b clinical trial with AZ-104 (Staccato loxapine)
prescription medicinesin patients with
migraine headaches.
About Alexza Pharmaceuticals, tramadol medication for dogs dosage Inc. Any statement describing a product candidate or Alexza's goals, expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary
products for the treatment of acute and intermittent conditions. The AZ-104 Phase 2b clinicalpain managementtrial is an outpatient, multi-center,
randomized, double-blind, single-dose, placebo-controlled study in approximately 360 patients who have migraines, with or without aura. The AZ-104 Phase 2b clinical trial is an outpatient, multi-center, randomized, double-blind, psoriatic arthritis treatment options single-dose, placebo-controlled study in approximately 360 patients who have migraines, with or without aura. AZ-104 met the primary efficacy endpoint of the clinical trial for the two highest doses of the drug compared to placebo. "Failure or delay in commencing or completing clinical trials for our product candidates could harm our business", "If our product candidates do not meet safety and efficacy
endpointstramadolin clinical trials, they will not receive regulatory approval, and
we will be unable to market them." and "We will need substantial additional capital in the future.
Acute migraine headaches occur often, usually one to four times a month. King, Alexza President and CEO. The Staccato system technology is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like
pharmacokinetics. Such statements arepain pillssubject to certain risks and uncertainties, particularly
those inherent in the process of developing and commercializing drugs.
In addition, according to the package inserts for triptans, they are contraindicated in patients with cardiovascular diseases, and amitriptyline hydrochloride side effects should not be given to patients with risk factors for coronary artery disease (e.g., hypertension, high cholesterol, cigarette smoking). Many migraine sufferers who do take triptans have an insufficient therapeutic response to these medications. Through a purchase option, Alexza retains the exclusive right, but not the obligation, to acquire
100% of the equity of Symphony Allegro at specified pricespain medsduring the term of
the agreement.
If Alexza chooses not to exercise the purchase option, Symphony Allegro retains the rights to the product candidates. AZ-104 was
generally safe and wellhair removal lotion reviewtolerated in this patient population. Secondary efficacy endpoints for the trial
include pain relief and other symptom assessments at various time points. SOURCE Alexza Pharmaceuticals, Inc..
AZ-104 and AZ-004 are being developed through Symphony Allegro, a product development partnership formed
between Alexza and SymphonydrugstoreCapital, LLC. About AZ-104 (Staccato loxapine) AZ-104 is the combination of Alexza's proprietary Staccato system with
loxapine, a drug belonging to the class of compounds known as dopamine receptor antagonists. Safe Harbor Statement This includes forward-looking statements regarding the development, therapeutic potential, efficacy and safety of AZ-104. ALXA) announced today that it has initiated a
Phasepain meds2b clinical trial with AZ-104 (Staccato loxapine) in patients with
migraine headaches. Data from this outpatient clinical trial will guide our future development plans for AZ-104 for the
treatment of migraine headaches." About Acutenatural progesterone cream reviewsMigraine Headaches According to the National Headache Foundation, approximately 13 million
people in the United States have been diagnosed with migraine headaches. The Company's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows rapid systemic drug delivery through deep
lungpain managementinhalation. Alexza
has completed and announced positive initial results from both of its AZ-004 Phase 3 clinical trials, and is projecting a New Drug Application submission in early 2010.
In addition, according to the package inserts for triptans, they are contraindicated in patients with cardiovascular diseases, and should not be given to patients with risk factors for coronary artery disease (e.g., hypertension, high cholesterol, cigarette smoking). Of the estimated 29.5 million migraine sufferers (including diagnosed and
undiagnosed sufferers),pain reliefthere are at least two groups of potential patients
for whom Alexza believes that AZ-104 could be effective and safe in comparison to triptans, which are the most commonly used class of therapeutics for treating migraine. "We
believe the potential value of the non-invasive nature andyasmin genericrapid onset of
pharmacological action provided by our Staccato system is well-suited for
migrainepain pillspain relief in the outpatient setting. Using the 4-point
rating scale, the primary efficacy endpoint was pain-relief at 2 hours post-administration. The primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose, using the standard 4-point rating scale (International Headache Society). "We believe the potential value of the non-invasive nature and rapid onset of pharmacological action provided by our Staccato system is well-suited for migraine pain relief in the outpatient setting. The Company has previously announced
positive results in two Phase 3 trials of AZ-004 and expects to submitvaltrex 1gm price
online pharmaciesa New
Drug Application for AZ-004 in early 2010.
The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. About Symphony Allegro In Alexza entered into a collaboration with Symphony
Capital LLC, a biotech-focused privateonline pharmacistequity firm.
About Symphony Allegro
In Alexza entered into a collaboration with Symphony
Capital LLC, a biotech-focused private equity firm. "We previously announced initial results with AZ-104 in an in-clinic setting, showing its positive effect treating pain and other key symptoms of migraine headache," said Pinchas B. Three doses of AZ-104 (1.25, 2.5 and 5 mg)
were evaluated against placeboprescription medicines
gyne lotrimin reviewsin the clinical trial.
Data from this outpatient clinical trial will guide our future development plans for AZ-104 for the treatment of migraine headaches."
About Acute Migraine Headaches
According to the National Headache Foundation, approximately 13 million
people in the United States have been diagnosed with migraine headaches. Safety evaluations will also be made throughout the clinical trial period. Alexza's lead program is AZ-004 (Staccato loxapine) that is being developed for the acute treatment of agitation in schizophrenic or bipolar disorder patients. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the
treatment of breakthroughonline pharmacypain, which is partnered with Endo Pharmaceuticals
in North America,
