Navigation Links
Alexza Reports 2010 Fourth Quarter and Full Year Financial Results and Provides General Corporate Update
Date:3/15/2011

novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza's technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.  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. (Click here to see an animation of how the Staccato system works.)

AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients.  Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials and submitted the AZ-004 NDA in December 2009.  In October 2010, the Company received a CRL from the FDA, regarding its NDA for AZ-004.  A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  The Company completed an end-of-review meeting with the FDA in late December 2010.  

The Company believes it has a clear understanding of the issues outlined in the CRL, is developing and executing a plan to address these issues, and currently projects a resubmission of the AZ-004 NDA in July 2011.  

For more information about Alexza, the Staccato technology or the Company's development programs, please visit www.alexza.com.

Safe Harbor Statement

Alexza's policy is to only provide guidance on product candidates and corporate goals for the future one to two fiscal quarters, and to provide, update or reconfirm its guid
'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Alexza to Announce 2010 Year-End Financial Results on Tuesday, March 15, 2011
2. Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
3. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
4. Alexza Pharmaceuticals Reports 2010 Third Quarter Financial Results and Provides Business Update
5. Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
6. Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
7. Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
8. Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
9. Alexzas Staccato® Nicotine Licensed to Cypress Bioscience
10. Alexza Pharmaceuticals to Present at Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference
11. Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... 17, 2015 Steven Rash , the CEO ... its operating subsidiary American Seed & Oil Company, presented ... investors yesterday in New York City.  Mr. Rash,s presentation ... American Seed & Oil Company has recently announced the ... Hemp Seed Foods , the EpiVape , and ...
(Date:4/17/2015)... and Markets ( http://www.researchandmarkets.com/research/256szd/corporate ) has announced ... in 2014 - a Perspective of Mental Health Patient ... For the first time, in 2014, the ... the pharmaceutical industry held by patient groups with an ... organisations representing all therapy areas. - Findings ...
(Date:4/16/2015)... April 16, 2015 Mindray Medical International ... and marketer of medical devices worldwide, announced today ... Exchange Commission an Annual Report on Form 20-F that ... 31, 2014. An electronic version of Mindray,s Annual ... investor relations website at  http://ir.mindray.com  or  http://www.sec.gov . ...
Breaking Medicine Technology:American Seed & Oil Company Benchmarks its Consumer Product Development Strategy Against Proctor & Gamble 2American Seed & Oil Company Benchmarks its Consumer Product Development Strategy Against Proctor & Gamble 3Corporate Reputation of Pharma in 2014 - The Perspective of Mental Health Patient Groups - 1st Edition 2Corporate Reputation of Pharma in 2014 - The Perspective of Mental Health Patient Groups - 1st Edition 3Mindray Files Annual Report on Form 20-F with the U.S. Securities and Exchange Commission 2
... May 22 Shire plc (LSE: SHP, Nasdaq: ... results of a study showing that coadministration of the ADHD ... (PPI) Prilosec OTC(R) 40 mg (20 mg X 2), did ... concentration of d -amphetamine to be reached in the ...
... Calif., May 21 Telik, Inc. (Nasdaq: TELK ... study of canfosfamide (TELCYTA(R), TLK286) in combination with pegylated liposomal ... annual meeting of the American Society of Clinical Oncology (ASCO) ... in Orlando, FL.Details of the presentation are as follows:, ...
Cached Medicine Technology:New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI) 2New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI) 3New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI) 4New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI) 5New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI) 6New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI) 7New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI) 8
(Date:4/17/2015)... (PRWEB) April 17, 2015 With Dr. ... Care has spent the last four years providing ... performing procedures ranging from general cleanings to dental implants ... grand opening at their new office in North Charlotte. ... services as their Concord office, including denture fittings, cosmetic ...
(Date:4/17/2015)... released a new blog post explaining the dangers of sleeping ... rates . , Falling asleep at the wheel can ... impact on auto insurance prices. The premiums will go up ... newly released blog post talks more about drowsiness at the ... is now possible to find low cost car insurance plans ...
(Date:4/17/2015)... Mario Badescu Botanical Exfoliating ... facial skin with its unique combination of finely ... energizing botanicals. This cushiony gel-based formula sloughs off ... and inhibit penetration of special treatments, serums, and ... Seeds, This uncommon exfoliating ingredient is an ecologically ...
(Date:4/17/2015)... Wholelifelifeinsurance.org has released a new ... life insurance policies . , Whole life insurance ... for their families at the same time. Whole life ... can be customized to it the client’s needs. ... clients take some appropriate steps.Comparing life insurance quotes is ...
(Date:4/17/2015)... 17, 2015 Verndale, a Global Experience ... once again been chosen as a Boston Business Journal ... company in the region. The BBJ’s Pacesetters represents privately ... 2011 through 2014. This is the eighth consecutive year ... that Verndale has been honored with this award. , ...
Breaking Medicine News(10 mins):Health News:Accidents Caused By Sleeping at The Wheel Can Increase Auto Insurance Costs 2Health News:Mario Badescu Skin Care Launches Botanical Exfoliating Scrub 2Health News:Whole Life Insurance Policies At Affordable Prices By Comparing Quotes 2Health News:Verndale Honored as 2015 Boston Business Journal Pacesetter, Named 46th Fastest Growing Private Company 2
... entirely online, announces participation of Dr. Larry Kaskel, Founder and Medical ... "Improved Patient Outcomes and Enhanced Revenue with Therapeutic Lifestyle Changes." ... ... CardioCareLive , the first of its kind online medical conference ...
... Economic Climate and Exceptional Events, - Operating Profitability Has Resisted Well, - Continued Reduction in Net Debt, ... 2007, Net sales ... 19.3 ... 11.5% 14.5%, Current operating income* ...
... NEW YORK, Feb. 18 The Michael J. ... million total to six teams working to develop ... visualize the clumping of the alpha-synuclein protein in ... accelerate research into the cause, progression and treatment ...
... The fight against bone disorders that affect ... from an ultrasound device being developed by space ... early prediction of bone disorders such as osteoporosis ... Biomedical Research Institute (NSBRI) scientists are developing ...
... Inc. (NYSE: WLP ) announced today that ... Attorney General regarding the manner in which out-of-network reimbursement ... the Agreement with the Attorney General, WellPoint has agreed ... it uses in determining out-of-network reimbursement for certain products ...
... Researchers at Rhode Island Hospital have completed a ... measures during a possible flu pandemic. Their study focused ... individuals showing no symptoms (asymptomatic) or from individuals who ... The researchers call on the scientific community to better ...
Cached Medicine News:Health News:Dr. Larry Kaskel, Medical Director of the Heart Attack Prevention Center, to Speak March 4th at CardioCareLive about FirstLine Therapy 2Health News:Dr. Larry Kaskel, Medical Director of the Heart Attack Prevention Center, to Speak March 4th at CardioCareLive about FirstLine Therapy 3Health News:PCAS: 2008 Results 2Health News:PCAS: 2008 Results 3Health News:Michael J. Fox Foundation Awards $1.9 Million for Development of Non-Invasive Neuroimaging Techniques in Living Brain 2Health News:Michael J. Fox Foundation Awards $1.9 Million for Development of Non-Invasive Neuroimaging Techniques in Living Brain 3Health News:SCAN: Delivering Bone Disorder Diagnosis, Fracture Healing 2Health News:SCAN: Delivering Bone Disorder Diagnosis, Fracture Healing 3Health News:WellPoint Joins New York Attorney General in Creation of New Independent Database for Out-of-Network Reimbursement 2Health News:Study calls for increased research in flu transmission to prepare for pandemic flu outbreak 2
... catheter or instrument introduction. The dual ... peeled away and removed. The maximum ... to be introduced should be measured ... sheath. Supplied sterile in peel-open packages. ...
... Used percutaneously to direct a ... wire guide to a specific ... has an inner stainless steel ... to the catheter shaft. Supplied ...
Used when establishing a percutaneous tract for nephrostomy drainage. The guide has a stiff shaft and a gradual transition to a very flexible distal tip. Supplied sterile in peel-open packages. Inten...
Supplied sterile in peel-open packages. Intended for one-time use....
Medicine Products: