Alexza Pharmaceuticals, Inc. and Grupo Ferrer International, SA, announced that they entered into a commercial partnership for Adasuve (Staccato loxapine). Adasuve is Alexza's lead programme, based on the company's proprietary technology, the Staccato system. Grupo Ferrer is a leading pharmaceutical company in Europe with extensive operations in the Americas, and will be Alexza's partner in the registration, distribution and promotion of Adasuve in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Alexza plans to file the Adasuve Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the second half of 2011. Adasuve is being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

“The treatment of agitation in patients with schizophrenia or bipolar disease continues to evolve in the field of psychiatry, and we believe that Adasuve could represent an important new therapeutic option for these patients,” said Thomas B King, Alexza's president and CEO. “Given Grupo Ferrer's extensive experience registering and selling specialty pharmaceuticals in Europe and Latin America, and their ability to share our longer-term vision for Adasuve, we believe they represent an ideal multi-region partner for Alexza as we execute our global commercialization strategy.”

“We welcome the opportunity to bring this innovative technology to our markets,” said Jordi Ramentol, CEO of Grupo Ferrer. “Adasuve fits perfectly into our specialty pharmaceutical portfolio. We strongly believe that the unique therapeutic benefits Adasuve provides will capture physicians' and patients' interest, and establish it as an important new tool in the treatment of agitation.”

Under the agreement, Alexza will receive an upfront payment of $10 million. Alexza is eligible to receive additional milestone payments based upon regulatory approvals, individual country commercial sales initiation and cumulative net sales targets. Alexza will be responsible for filing the Adasuve MAA with the EMA. Grupo Ferrer will be responsible for all subsequent regulatory filings in the countries in its territories, as well as any required pricing and reimbursement filings and approvals. Assuming regulatory approvals are obtained, Grupo Ferrer will exclusively distribute, market and sell Adasuve in the designated territory. Alexza will be the exclusive supplier of Adasuve to Grupo Ferrer for all of its commercial sales, at a per-unit transfer price.

Adasuve is an anti-agitation therapeutic that combines Alexza's proprietary Staccato system with loxapine, an antipsychotic drug. Loxapine is currently available in oral and other formulations, inside and outside of the US and European Union. The Staccato system is a hand-held, single-dose inhaler that delivers a drug aerosol to the deep lung that results in IV-like pharmacokinetics and rapid systemic effects.

As an easy-to-use, non-coercive and highly reliable inhaled therapeutic that has been shown to produce a rapid reduction in agitation, Alexza believes that Adasuve meets the three key attributes for the treatment of acute agitation as specified in the American Association of Emergency Psychiatrists' Expert Consensus Guidelines for the Treatment of Behavioural Emergencies: speed of onset, reliability of medication delivery and patient preference. Similarly, the National Institute for Health and Clinical Excellence (NICE) Clinical Practice Guidelines describe an ideal treatment for agitation as having a low level of side effects and a rapid onset of action, and that injections should be administered only in exceptional circumstances.

Alexza's proprietary Staccato system was rationally designed to optimally treat acute and intermittent conditions. A single breath triggers vaporization and delivers a dose of excipient-free aerosolized, highly bioavailable drug deep into the lungs, where it is quickly absorbed into the blood stream to begin providing therapeutic effect. The Staccato system delivers medication that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.

The Staccato system is unique among inhalers because it uses no excipients, requires no special breathing maneuvers and there are no controls to deal with. When the patient draws a single normal breath through the Staccato device, the substrate surface instantly heats to create a condensation aerosol of optimally-sized particles of drug that are drawn into the patient's lungs. The entire Staccato system actuation and drug delivery occur in less than one second. The system produces a consistently high emitted pre-set dose, regardless of the patient's breathing pattern.

Alexza has screened more than 400 drug compounds and more than 200 drug compounds exhibit initial vaporization feasibility with the Staccato system. Since the filing of the Company's first IND in 2004, Alexza has dosed more than 2,600 patients and subjects with its Staccato technology, in 22 different clinical trials under six different INDs for Staccato-based product candidates.

Grupo Ferrer is a privately-held European R&D-based pharmaco-chemical and medical device company. It carries out activities throughout the full value-chain of the pharma business, from R&D to international marketing, including fine chemicals development and both raw material and pharmaceutical product manufacturing.

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.