Alexza Pharmaceuticals has reacquired U.S. commercial rights for ADASUVE^® (loxapine) inhalation powder from Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. Alexza and Teva have also restructured the obligations under the outstanding note from Teva. In conjunction with the reacquisition of U.S. ADASUVE rights, Alexza and Teva have completed a transition agreement, which is intended to provide continued availability of ADASUVE by Alexza to patients and health care providers. 

Terms of the ADASUVE Product Reacquisition

• The ADASUVE NDA and related regulatory filings will be transferred to Alexza. Alexza will assume responsibility for all regulatory activities related to ADASUVE in the U.S.
• Responsibility for the ADASUVE U.S. Phase 4 study, product pharmacovigilance, medical services, and REMS compliance will be transferred to Alexza over the course of the next 90 days. Alexza intends to continue these activities with the relationships and agreements established by Teva.
• Teva will transfer to Alexza product inventory, promotional materials, and other ADASUVE trade materials. Alexza will have the ability to promote and distribute ADASUVE, under the currently approved label and labeling for up to 12 months, including to existing customers, subject to certain limitations.
• Alexza will take over responsibility for administering the ongoing investigator sponsored studies and the directed research grant.

Terms of the Teva Note Restructuring

• Alexza will issue approximately 2.17 million shares to Teva as consideration for the reduction in the Teva note by $5 million of principal and forgiveness of all accrued and unpaid interest. After the share issuance, Teva will own approximately 9.9% of Alexza's outstanding common stock.
• The remaining Teva note balance will become payable in the first calendar year following the calendar year in which the aggregate annual net sales of ADASUVE and any other Staccato-based products first reach $50 million in the U.S. After the U.S. sales reach this threshold, the $20 million note balance will be due and will be payable in four consecutive annual payments of $5 million each.

"We appreciate the efforts that Teva has made to date and are looking forward to continuing to build the ADASUVE brand. We remain confident in ADASUVE's long-term commercial prospects and plan to continue to work with Teva to effect a smooth transition," saidThomas B. King, Alexza President and CEO. "Moving forward, Alexza will have primary responsibility for the immediate commercial aspects of ADASUVE and is working diligently to identify a new U.S. commercial partner for ADASUVE."