October FDA decision due for Alexza Pharmaceuticals |
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By Patrick Crutcher |
Friday, 09 July 2010 08:39 |
ALXA has an FDA decision for Staccato loxapine (AZ-004) to treat agitation in schizophrenia and biopolar disorder on October 11th. Currently, there is no planned advisory panel meeting. This could be seen as a good sign for ALXA since panels are typically convened when the FDA has questions about the efficacy and safety of a clinical trial or a clinical endpoint that needs clarification. Approval would certainly be a validation of their unique technology(Staccato) which mimics intravenous inhalation. This platform allows for consistent and reliable pure drug delivery to the lungs. There is no other device/technology that can do the same. Physicians get speed, predictability, and ease of use. A video demonstrating the technology can be found here. Alexza has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccato loxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache.They are also looking at the insomnia and breakthrough pain markets. More on the pipeline here. Biovail is charged with everything on the commercial side. Preparing for launch, building a sales force, marketing organization, reimbursement, pricing, and medical education. ALXA received a $40 mill upfront payment and $90 million additional milestones with a tiered double digit royalty based on top-line sales (10-25%). They estimate the market potential to be between $300-500M per year. JPM Securities has them rated at “Market Outperform” with a $12 price target, that is a 500% increase from current levels. Patrick Crutcher is the managing editor of the biotech stock blog chasingthealpha.com "Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |