Lee's Pharmaceutical Holdings Limited (0950.HK) ("Lee's Pharmaceutical" or "the Company") announced today that its wholly-owned subsidiary Nova Pneuma Inc. ("NPI"), incorporated in Delaware, has acquired the assets of Alexza Pharmaceuticals, Inc. ("Alexza"). Upon completion of the transaction, Lee's Pharmaceutical and NPI will gain full ownership of the Staccato® One Breath Technology® ("Staccato® OBT®") platform technology and related assets, including intellectual property, platform technology, trademarks, product pipeline, equipment, product pipeline, and access to GMP facilities, as well as the rights to Alexza as the licensor and manufacturing supplier of Staccato® alprazolam. This strategic move strengthens Lee's Pharmaceutical's capabilities in the field of aerosol inhalation drug delivery, expands the company's inhalation product pipeline, and aligns with its global expansion strategy. The transaction is still subject to certain closing conditions and is expected to be completed by the end of 2025.

GMP facility, Fremont, California, USA

Proprietary and Highly Validated Staccato® One Breath Technology®

The acquisition of the Staccato® OBT® platform technology marks a significant step in the company's strategic expansion, granting it full ownership of this technology platform. The maturity and reliability of this platform have been successfully validated through the approved product Adasuve® and multiple late-stage clinical development projects based on the Staccato® technology platform. This strategic move not only enhances the company's drug delivery capabilities but also lays the foundation for future innovations in inhalation therapy.

Synergy with Lee's Pharmaceutical's Existing Product Pipeline

The acquisition brings significant synergies to the company's existing pipeline. The company has been advancing clinical development of drugs targeting breakthrough cancer-related pain based on the Staccato® technology platform and has already commercialized Adasuve® in Greater China for the treatment of acute agitation in adults with schizophrenia or bipolar I disorder. Upon completion of the acquisition, the company will no longer need to pay any subsequent licensing fees to Alexza, resulting in immediate cost savings and optimization of the overall transaction economics.

Additionally, two central nervous system pipeline assets for Parkinson's disease and cyclic vomiting syndrome (CVS) (both in Phase II clinical trials) will be added to the company's product portfolio, unlocking new commercial opportunities.

Acquisition of Global Rights as Licensor and Manufacturing Supplier of Staccato® Alprazolam, Deepening Global Collaboration with UCB

In addition to the above benefits, the company has also acquired Alexza's rights and obligations under the existing global licensing and manufacturing supply agreement, with UCB, a biopharmaceutical company with strong influence in the field of epilepsy treatment, as the partner. Under the agreement, UCB holds and will continue to hold the global development and commercialization rights for Staccato® alprazolam, which is currently in Phase III clinical trials (ClinicalTrial.gov ID: NCT05077904), further validating the clinical maturity and commercial potential of the Staccato® OBT® technology platform. UCB acquired Engaged Therapeutics, Inc. in June 2020 to obtain Staccato® alprazolam and signed an updated global licensing and related commercial supply agreement with Alexza.

Upon achieving specific development, regulatory, and sales milestones, Lee's Pharmaceutical and NPI will receive milestone payments totaling up to $60.5 million, as well as tiered royalties based on global net sales and manufacturing revenue generated from the global supply of Staccato® alprazolam.

"We are pleased to collaborate with UCB to address critical unmet needs in the treatment of epileptic seizures. This transaction not only brings near-term financial benefits but also enables us to achieve sustained growth in high-value therapeutic areas, marking an important milestone in the company's global expansion strategy," said Ms. Li Yeni, Managing Director of Lee's Pharmaceutical.

"Under the leadership of the new management team, we will continue to work closely with UCB to ensure the delivery of innovative and reliable therapies to patients. We look forward to bringing more Staccato® technology platform-based drugs to patients worldwide, reinforcing our shared commitment to improving lives through innovative science," said Dr. Wolfgang Schmidt, Senior Vice President of Manufacturing and Operations at NPI.