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news.Teva Pharmaceuticals USA has obtained commercialization rights to Alexza Pharmaceuticals' Adasuve (loxapine) inhalation powder 10mg in the country.
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Adasuve (loxapine) inhalation powder is indicated for the acute treatment of agitation coupled with schizophrenia and bipolar I disorder.
Under the US license and supply agreement, Teva will take care of all the commercial and clinical activities of the product such as US post-approval clinical studies.
The agreement also grants Teva the rights to conduct additional clinical trials to assess the Adasuve’s probable new indications in neurological disorders. Alexza is responsible for manufacturing and supply activities.
Alexza president and CEO Thomas King said, "ADASUVE is approved to address agitation episodes in the hospital-setting, providing a fast-acting, non-coercive treatment option to patients with schizophrenia and bipolar I disorder."
According to the terms of the deal, Alexza will earn $40m upfront cash payment, $195m in additional milestone payments upon successfully completing the Adasuve post-approval studies in the US and reaching net sales targets, in addition to sales-based royalties.
Alexza may access around $25m that is made available by Teva, through a five-year convertible note and agreement to lend, and prepay 50%outstanding amount before maturity.
At maturity, Teva has an option to convert all or a portion of the then outstanding amount under the note into equity of Alexza.