Lee’s Pharmaceutical Holdings subsidiary Nova Pneuma has acquired inhaled drug delivery technology and other assets developed by Alexza Pharmaceuticals, the company said. Alexza merged with Grupo Ferrer in 2016. The deal, which is expected to close by the end of the year, includes the Staccato One Breath Technology API-only delivery platform and Staccato alprazolam, which is currently in Phase 3 development for the treatment of epileptic seizures.
Lee’s says that it may earn milestone payments of as much as $60.5 million plus royalties on global net sales of Staccato alprazolam, as well as revenue from manufacturing and supply of the inhaler. Assets related to the Staccato OBT platform include “intellectual property, know-how, trademarks, product pipeline, equipment, products and access to GMP facility, and Alexza’s right as licensor and manufacturer of Staccato alprazolam,” the company notes.
Engage Therapeutics acquired rights to Staccato alprazolam from Alexza in 2017, and UCB acquired Engage and the inhaled alprazolam in 2020 shortly after Engage reported that the Phase 2b StATES study of Staccato alprazolam for the treatment of epileptic seizures had met its primary endpoint. According to the announcement, UCB will continue to hold global rights to Staccato alprazolam and will now pay licensing and manufacturing supply fees to Lee’s.
The only currently approved Staccato product is Adasuve Staccato loxapine, which was approved in the US in December 2012 and in Europe in February 2013. Lee’s says that it has already been developing several other Staccato products and commercializing Adasuve for acute agitation in schizophrenia or bipolar disorder in China, noting that it will no longer have to pay licensing fees on those products.
Lee’s says, “This strategic move strengthens Lee’s Pharm’s aerosolized inhalation drug delivery capabilities, expands the Company’s inhalation product pipeline, and aligns with the Company’s global expansion strategy.” In addition to Adasuve, the company also mentions the acquisition of “two promising CNS pipeline assets targeting Parkinson’s disease and Cyclic Vomiting Syndrome (CVS), both at Phase 2 clinical stage” and a Staccato inhaler for breakthrough pain in cancer patients that Lee’s already has in clinical development.
Lee’s Pharmaceutical Holdings Director Benjamin Li commented, “Acquiring the Staccato OBT platform is a transformative step for Lee’s Pharm, reinforcing our commitment to innovation in inhalation therapeutics targeting CNS and neurodegenerative disorders, and expanding our global footprint. This transaction not only strengthens our pipeline and inhalation R&D capabilities but also creates new revenue streams through the strategic partnerships with UCB.”
Read the Lee’s Pharmaceutical Holdings press release
