The clock is ticking, and there are only a few days left for an FDA advisory panel to review Alexza Pharmaceuticals Inc.'s (ALXA) inhalation product candidate Adasuve for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. This is Adasuve's second go-around with the FDA.
Adasuve is a drug-device combination which uses Alexza's proprietary Staccato system to deliver the drug Loxapine into the patient's lungs. The Staccato system helps the drug to be quickly absorbed through the lungs into the bloodstream, providing rapid relief that is comparable to intravenous administration, but with greater ease, patient comfort and convenience, according to Alexza. The antipsychotic Loxapine was approved by the FDA in 1975 and is available in oral and injectable formulations in the United States. Loxapine is also available in generic form.
The NDA for Adasuve, which was initially submitted in December 2009, failed to clear regulatory muster in its first round. A Complete Response Letter issued for the Adasuve NDA last October, raised concerns related to pulmonary safety of the drug. Resolving the issues raised in the Complete Response Letter, Alexza resubmitted its Adasuve NDA on August 4, 2011 and the FDA is slated to give its final word on February 4, 2012.
Meanwhile, before the FDA makes a final decision, the Psychopharmacologic Drugs Advisory Committee is scheduled to review the safety and efficacy issues of Adasuve on December 12, 2011 and make its recommendations. The FDA usually follows the recommendations of its advisory panels, but is not required to do so.
Alexza submitted its application seeking approval for Adasuve in Europe last month and is optimistic that it will receive timely European review. The company has a partnership with Grupo Ferrer for commercialization of Adasuve in Europe, Latin America, Russia and the Commonwealth of Independent States countries.
If approved, Adasuve has the potential to earn $400 million to $500 million yearly, according to analysts.
Another drug candidate of Alexza, which is in active development is AZ-007 for the treatment of insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep, which has completed phase 1 testing. Alexza has no plans to spend external resources for the development of AZ-007 through at least the fourth quarter of 2011, but is continuing internal work on the technical product development.
The company's product candidates not in active development include, AZ-104 for the treatment of acute migraine headaches, AZ-002 for the treatment of panic attacks and AZ-003 for the treatment of acute pain.
In August of 2010, the company licensed its Staccato nicotine technology to Cypress Bioscience Inc. The Staccato nicotine technology is an electronic multidose delivery system designed to help people stop smoking. Cypress is responsible for preclinical, clinical and regulatory aspects of the development of Staccato nicotine, along with the commercialization of the product. Through September 30, 2011, Cypress has paid Alexza a total of $3.9 million towards the execution of the development plan of Staccato nicotine.
Alexza has incurred significant losses since inception in December 2000 and has an accumulated deficit of $296.9 million. In the third quarter ended September 30, 2011, the company incurred a net loss of $13.4 million or $0.19 per share wider than a net loss of $0.59 million or $0.01 per share in the year-ago quarter. Revenue for the quarter rose to $1.3 million, up from $0.7 million last year.
Alexza went public in March 2006 , pricing its shares at $8 each. Over the past 1 year, the stock has traded in a range of $0.86 to $1.91. ALXA closed Monday's trading at $0.93, down 6%.
Some drugs make it to the finish line, passing the FDA muster with ease. But many struggle through the arcane process of regulatory approval. Will the panel give a thumbs up to Alexza's Adasuve? Stay tuned...
by RTT Staff Writer
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