Lee's Pharmaceutical Acquires Staccato Inhalation Technology Platform in Strategic Deal with UCB Partnership
核心洞察
Lee's Pharmaceutical Holdings Limited (搜索) announced the acquisition of Staccato One Breath Technology platform from Alexza Pharmaceuticals (搜索), strengthening its inhalation drug delivery capabilities and expanding its therapeutic pipeline.
The deal includes full ownership of the validated technology platform supported by approved product Adasuve and late-stage development programs, plus two Phase 2 CNS assets targeting Parkinson's disease and Cyclic Vomiting Syndrome.
Lee's Pharm acquires manufacturing and licensing rights for Staccato alprazolam under UCB (搜索)'s global partnership, with potential milestone payments up to $60.5 million and tiered royalties on worldwide sales.
Lee's Pharmaceutical Holdings Limited (搜索) has announced a transformative acquisition of the Staccato One Breath Technology platform from Alexza Pharmaceuticals (搜索), Inc., positioning the Hong Kong-based biopharmaceutical company to expand its inhalation therapeutics capabilities and strengthen its global footprint in CNS disorders.
The transaction, executed through Lee's Pharm's wholly owned Delaware subsidiary Nova Pneuma Inc (搜索). (NPI), grants full ownership of the Staccato One Breath Technology (Staccato OBT) platform and related assets, including intellectual property, know-how, trademarks, product pipeline, equipment, and access to GMP manufacturing facilities. The deal is expected to close by the end of 2025, subject to certain closing conditions.
Validated Technology Platform with Proven Clinical Success
The Staccato OBT platform represents a unique drug delivery technology that delivers excipient-free drugs as rapidly as intravenous injection but through non-invasive inhalation, resulting in rapid onset of therapeutic effect. The technology is particularly suited for treating acute conditions requiring quick relief and has been validated through extensive clinical studies across multiple compounds and therapeutic indications.
The platform's clinical maturity is demonstrated by the approved product Adasuve, used for acute agitation in adult schizophrenia or bipolar I disorder, which Lee's Pharm has been commercializing across Greater China. The acquisition also includes several Staccato-based late-stage development programs, reinforcing the platform's commercial potential.
Strategic Pipeline Expansion and Cost Synergies
The acquisition delivers immediate synergies with Lee's Pharm's existing pipeline, particularly its clinical development of Staccato-based medicine for cancer-related breakthrough pain. Upon completion, all future licensing payment obligations to Alexza for the development and commercialization of Staccato-based medicines and Adasuve will be eliminated, delivering immediate cost savings and enhancing overall deal economics.
Two promising CNS pipeline assets will be integrated into Lee's Pharm's portfolio: treatments targeting Parkinson's disease and Cyclic Vomiting Syndrome (CVS), both currently at Phase 2 clinical stage. These additions unlock new commercial opportunities in high-value therapeutic areas where the company seeks to address critical unmet medical needs.
UCB Partnership and Revenue Potential
A key component of the acquisition involves Lee's Pharm assuming Alexza's rights and obligations under the existing worldwide licensing and manufacturing supply agreement with UCB (搜索), a biopharmaceutical company with strong presence in epilepsy treatment. Under this arrangement, UCB retains global development and commercialization rights for Staccato alprazolam, which is currently advancing through Phase 3 clinical trials (ClinicalTrial.gov ID: NCT05077904).
UCB (搜索) originally acquired Engaged Therapeutics (搜索), Inc. for Staccato alprazolam in June 2020 and subsequently entered into an updated license and commercial supply agreement with Alexza. The partnership structure positions Lee's Pharm to receive milestone payments totaling up to $60.5 million upon achieving specified development, regulatory, and sales milestones, along with tiered royalties on global net sales of Staccato alprazolam and manufacturing revenue from worldwide supply.
Leadership Perspectives on Strategic Value
"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," said Dr. Benjamin Li, Founder and Director of Lee's Pharmaceutical Holdings Limited (搜索). "This transaction not only strengthens our pipeline and inhalation R&D capabilities but also creates new revenue streams through the strategic partnerships with UCB (搜索)."
Ms. Wanee Lee, Managing Director of Lee's Pharmaceutical Holdings Limited (搜索), emphasized the partnership's therapeutic focus: "We are delighted to partner with UCB (搜索) as it commits and advances solutions to address critical unmet needs in epileptic seizure therapy. This transaction not only delivers near-term financial benefits but also positions us for sustained growth in high-value therapeutic areas, marking a significant milestone in the Company's global expansion strategy."
Dr. Wolfgang Schmidt, SVP Manufacturing and Operations at NPI, highlighted the operational continuity: "Under the new leadership, our team is energized to continue collaborating closely with UCB (搜索) and to ensure the reliable manufacture of meaningful therapy for patients with significant unmet needs. We are equally excited about the opportunity to bring additional Staccato-based medicines to patients around the world."
Company Background and Strategic Focus
Lee's Pharmaceutical Holdings Limited (搜索) operates as a research-driven and market-oriented biopharmaceutical company with over 30 years of experience in the pharmaceutical industry in China. The company maintains fully integrated infrastructure spanning drug development, clinical development, regulatory affairs, manufacturing, sales and marketing, with operations based in Mainland China and global perspectives.
The company has established extensive partnerships with approximately 30 international companies and currently markets over 25 proprietary, generic and licensed-in pharmaceutical products across Mainland China, Hong Kong, Macau and Taiwan. Lee's Pharm focuses on key therapeutic areas including cardiovascular health, women's health, pediatrics, rare diseases, oncology, dermatology and obstetrics.
The Staccato OBT platform acquisition aligns with the company's strategic focus on addressing unmet medical needs through innovative drug delivery technologies, particularly in CNS and neurodegenerative disorders where rapid onset of action can provide significant clinical benefits for patients requiring immediate therapeutic intervention.