Avadel Pharmaceuticals Licenses Valiloxybate from XWPharma for Sleep Treatments.

• Avadel Pharmaceuticals licenses Valiloxybate from XWPharma Ltd. • Valiloxybate is a once-at-bedtime oxybate for narcolepsy and idiopathic hypersomnia. • Initial PK study to start in Q4 2025, pivotal PK trial in H2 2026. • XWPharma receives $20 million upfront, potential milestone payments, and royalties. • Avadel expands sleep medicine portfolio with a salt-free, artificial sweetener-free treatment.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) has bolstered its sleep medicine portfolio with an exclusive global license agreement to develop and commercialize valiloxybate, a once-at-bedtime oxybate for the treatment of narcolepsy and idiopathic hypersomnia (IH). The agreement with XWPharma Ltd. aims to expand Avadel's pipeline with a salt-free, artificial sweetener-free formulation of the drug.

Under the terms of the agreement, Avadel will receive an upfront payment of $20 million from XWPharma. The deal also includes potential milestone payments and tiered royalties, with a significant portion tied to sales milestones. Avadel expects to initiate an initial pharmacokinetic (PK) study in the fourth quarter of 2025, followed by a pivotal PK trial in the second half of 2026. The program is expected to leverage Avadel's existing infrastructure and commercial capabilities, potentially allowing for efficient clinical and regulatory advancement via a bioequivalence pathway.

Valiloxybate is a GABAB receptor agonist designed to deliver the therapeutic benefits of oxybate therapy through a once-at-bedtime formulation. Preliminary clinical data suggest the potential for bioequivalence to be established between valiloxybate and Avadel's LUMRYZ, the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. This could potentially streamline the development pathway for valiloxybate.

Avadel's Chief Executive Officer, Greg Divis, stated, "The addition of valiloxybate further reflects Avadel’s position as a leader in sleep medicine. We are excited to add valiloxybate to our pipeline and offer personalized care to more individuals living with these conditions." James Huang, Executive Chairman of XWPharma, expressed his enthusiasm for the partnership, noting, "We are pleased to enter into this licensing agreement with Avadel and look forward to offering access to this innovative therapy to a broad population of those living with sleep disorders."

The agreement excludes mainland China, Hong Kong, and Macau, with Avadel responsible for development, manufacturing, and commercialization worldwide. The deal underscores Avadel's commitment to innovation and novel drug delivery systems, aiming to improve the lives of those living with hypersomnolence disorders.

References:
[1] https://www.stocktitan.net/news/AVDL/avadel-pharmaceuticals-strengthens-sleep-medicine-portfolio-with-mebbvjgjx37a.html