Alexza Pharmaceuticals licensed its Staccato nicotine technology to Cypress Bioscience for $5 million. The Staccato technology will be used to improve on a well-validated smoking cessation approach by delivering nicotine via inhalation but avoiding the harmful side effects associated with cigarettes.
Following the completion of certain preclinical and clinical milestones relating to the Staccato nicotine technology, Cypress will be obligated to pay Alexza a technology transfer payment of $1 million. Cypress will be responsible for preclinical and clinical development as well as regulatory procedures and commercialization. Alexza will have a carried interest of about 10% in the net proceeds of any sale or license by Cypress of the Staccato nicotine assets. The carried interest will be subject to put and call rights in certain circumstances.
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 reportedly comparable to intravenous administration, but with greater ease, patient comfort, and convenience.
The Staccato technology may be capable of mimicking the pharmacokinetics of smoking cigarettes through the delivery of optimally sized nicotine particles to the deep lung, Alexza explains. Staccato nicotine may also provide some of the psychological aspects of smoking (e.g., hand-to-mouth movement, oral inhalation) and could allow smokers to self-administer and possibly titrate to the dose to treat cravings. Alexza adds that the Staccato delivery system could allow for the programmed, over-time reduction in the overall daily dose of nicotine.
"The Staccato system is a broad technology platform and Alexza has more Staccato-based product candidates than we can currently afford to develop on our own," reports Thomas B. King, Alexza president and CEO. Lead program Staccato loxapine, AZ-004, is being developed for the treatment of agitation in schizophrenic or bipolar disorder patients.
Alexza submitted an NDA in December 2009, and has a PDUFA goal date of October 11, 2010. In February of this year it inked a partnership with Biovail Laboratories to develop and commercialize AZ-004 in the U.S. and Canada.
Alexza also recently said that it will advance Staccato zaleplon, AZ-007, into Phase II beginning the first half of next year. The compound is being developed for the treatment of insomnia in patients who have difficulty falling asleep, including those patients who awake in the middle of the night and have difficulty falling back asleep.
Additionally, the company has finished Phase II trials with AZ-001 (Staccato prochlorperazine) and AZ-104 (Staccato loxapine) in migraine headaches. A Phase IIa study with AZ-002 (Staccato alprazolam) in acute panic attacks was inconclusive, but the firm is evaluating other indications. The firm successfully completed Phase I trials with AZ-003 (Staccato fentanyl) in breakthrough pain and AZ-007 in insomnia.