Alexza Pharma (ALXA) Updates on Commercial Progress of ADASUVE in U.S. (TEVA)

Alexza Pharma (Nasdaq: ALXA) provided an update on the U.S. commercial progress with ADASUVE® (loxapine) inhalation powder (Staccato® loxapine). Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is Alexza's commercial partner for ADASUVE in the United States. Teva and Alexza announced the commencement of the U.S. launch of ADASUVE in March 2014.

"During the third quarter, we shipped 32,278 units of ADASUVE to Teva, completing the initial product inventory stocking of ADASUVE for the U.S. markets. Initial product sales will be sourced from this inventory stocking," said Robert A. Lippe, Executive Vice President and Chief Operations Officer of Alexza. "We do not expect to ship any additional product to Teva until early 2015. As the U.S. distribution channel inventory is depleted by product sales, we plan to continue product shipments to address product demand and sales."

"It is early in the U.S. ADASUVE launch. All hospital products go through the required processes for a product to be stocked in the hospital and then used by physicians," said Thomas B. King, President and CEO of Alexza. "These processes are no different for ADASUVE. With five quarters of EU sales experience and two quarters of U.S. sales experience, we and our commercial partners are seeing what we view as positive progress in the important measures of the product launch process."

Alexza provided the following additional updates on ADASUVE in the U.S.:

• Alexza shipped 32,278 units in the third quarter, completing the ADASUVE initial product inventory stocking. Total shipments to Teva have been 83,404 units to date, in order to fill the distribution network from which to stock hospital pharmacies and support sales.
• Alexza is seeing early launch trends in measureable activities on a monthly basis that are similar to those observed early in the European launches. Alexza anticipates a similar uptake trajectory in the U.S., characterized by steady growth in the number of hospitals stocking ADASUVE, which then results in increasing levels of product sales as a result of product use at each individual hospital.
• Alexza has completed manufacturing process validation for an increased production batch size of 10,000 units. The successful completion of these activities allows for greater flexibility in the production scheduling and planning for U.S. ADASUVE production, and is part of the continued work on longer-term reduction of cost of goods for ADASUVE.
• Teva is responsible for U.S. post-approval clinical studies. ADASUVE is being studied in a non-randomized, open-label, multicenter Phase 1 study to assess the safety and pharmacokinetics of the product at doses of 2.5, 5, or 10 mg in children and adolescents. This study has been initiated. Additional information about this clinical trial can be found at clinicaltrials.gov.

About Teva - Alexza AgreementTeva licensed the U.S. commercial rights to ADASUVE in May 2013 from Alexza. Under the terms of the license and supply agreement, Teva is responsible for all U.S. commercial and clinical activities for ADASUVE, including U.S. post-approval clinical studies. Alexza is responsible for manufacturing and supplying ADASUVE to Teva for commercial sales and clinical trials. Alexza is eligible to receive tiered royalty payments based on net commercial sales of ADASUVE, as well as certain milestone payments, based upon successful completion of the ADASUVE post-approval studies in the U.S and the achievement of net sales targets.

About ADASUVE (Staccato® loxapine)ADASUVE is the first and only inhalation therapy for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The US marketing authorization for ADASUVE requires that patients are screened and monitored for respiratory events as part of the risk and mitigation strategy. It also requires that ADASUVE be administered only in a hospital setting under the supervision of a healthcare professional. In the United States, approximately 2.4 million adults have schizophrenia and approximately 5.7 million adults have bipolar disorder. More than 90% of patients with schizophrenia or bipolar disorder will experience agitation in their lifetimes1. For the full prescribing information including boxed warnings for the U.S., please visit www.adasuve.com.

ADASUVE combines Alexza's proprietary Staccato system with loxapine, an antipsychotic medicinal product. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in intravenous-like pharmacokinetics and rapid systemic effects.

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