Teva Pharmaceuticals USA, Inc., subsidiary of Teva Pharmaceutical Industries Ltd (TEVA), a pharmaceutical company, and Alexza Pharmaceuticals, Inc. (ALXA), which is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions, Wednesday announced that the companies have entered into an exclusive U.S. license and supply agreement for ADASUVE (loxapine) inhalation powder 10 mg.
Pursuant to the agreement, Alexza will receive an upfront cash payment of $40 million and is eligible to receive up to $195 million in additional milestone payments, based upon successful completion of the ADASUVE post-approval studies in the U.S. and achieving net sales targets. In addition, Teva will make tiered, royalty payments based on net commercial sales of ADASUVE.
Teva also will make available up to $25 million to Alexza via a five-year convertible note and agreement to lend, which Alexza may access to support its ADASUVE activities.
Teva will be responsible for all U.S. commercial and clinical activities for ADASUVE, including U.S. post-approval clinical studies, and has gained rights to conduct additional clinical trials of ADASUVE for potential new indications in neurological disorders. Alexza will be responsible for manufacturing and supplying ADASUVE to Teva for commercial sales and clinical trials.
ADASUVE is used for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
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