Based on its recent analysis of the bipolar disorder therapeutics market, Frost & Sullivan recognises Alexza Pharmaceuticals with the 2012 Global Enabling Technology Award for its core proprietary technology - Staccato®.
Staccato® is a novel method of inhaled drug delivery that is exclusively customised for conditions requiring rapid speed of therapeutic effect, reliable dosing and ease-of-use. Currently, Alexza Pharmaceuticals has developed a single-dose disposable platform and a multi-dose platform with reusable controller. The Staccato® system eliminates the need for excipients and additives, such as detergents, solvents and stabilisers, thereby reducing the possible associated side-effects for patients.
ADASUVE™ (Staccato® loxapine) is the flagship product of Alexza Pharmaceuticals, based on Staccato® platform, which is being developed for the acute treatment of agitation associated with bipolar disorder or schizophrenia. ADASUVE™ meets all the three key attributes in the treatment guidelines outlined by the American Association for Emergency Psychiatry - speed of onset, predictability of medication delivery and patient preference.
"With a single normal breath, the Staccato® technology delivers an accurate, rapidly absorbed dose of loxapine through the deep lung," noted Frost & Sullivan Research Analyst Aiswariya Chidambaram. "Loxapine, noted for its excellent receptor-binding attributes and positive side-effect profile, is likely to be a preferred antipsychotic of physicians treating agitation."
At present, nearly 5.7 million and 3.1 million adults in the United States and Europe, respectively, suffer from bipolar disorder. The limitations of current therapies and drugs have highlighted the enormous commercial potential of ADASUVE™.
"ADASUVE™ offers a non-invasive, rapid-acting and patient-friendly therapy option, which ensures safe, effective and early intervention well before the agitation episodes escalate out of control," remarked Chidambaram. "It also offer betters results in emergency conditions, when agitation has reached a crisis level."
Alexza Pharmaceuticals has successfully completed two separate phase III trials for schizophrenia (344 patients) and bipolar disorder (314 patients), wherein ADASUVE™ showed statistically significant primary and secondary endpoint results as compared to placebo.
Alexza Pharmaceuticals anticipates U.S. FDA regulatory approval for ADASUVE™ by the end of 2012 and is projecting a launch of the product by mid-year 2013 in the United States and Europe. This first-in-class, anti-agitation product is expected to hold huge market potential and business opportunities in terms of commercialisation.
"In anticipation of regulatory approval, Alexza Pharmaceuticals has already established strong technology and materials supply relationships and has built a clinical good manufacturing practice (cGMP) facility in California," stated Chidambaram. "The company plans to commercialise this pioneering technology globally and has already been pro-active in forging strategic partnerships with leading pharmaceutical companies."
Frost & Sullivan presents this award to the company for developing a technology that enables the creation of new products and applications and/or enhances current products. The potential for market acceptance and breadth of access to the technology also underpin the receipt of this award.
Frost & Sullivan Best Practices awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.
About Alexza Pharmaceuticals
Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza was founded in 2000 by noted biotechnology and drug delivery entrepreneur, Dr. Alejandro Zaffaroni, with the vision of creating new therapies to treat acute and intermittent medical conditions through a new and novel technology. Alexza's invented 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. With the Staccato system, a 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.
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