Avadel: XWPharma to receive $20m upfront

Avadel: XWPharma to receive $20m upfront

Avadel Pharmaceuticals plc (AVDL) has entered into an exclusive global license agreement with XWPharma Ltd. to develop and commercialize valiloxybate, a GABAB receptor agonist for the treatment of sleep disorders, including narcolepsy and idiopathic hypersomnia (IH). The agreement includes an upfront payment of $20 million to XWPharma, with potential milestone and royalty payments tied to development and sales milestones [1].

Valiloxybate, designed to deliver therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free, and artificial sweetener-free formulation, aims to expand Avadel's sleep medicine portfolio. The molecule is set to undergo initial pharmacokinetic (PK) studies in the fourth quarter of 2025, with a pivotal PK trial planned for the second half of 2026. Avadel expects to leverage its existing infrastructure and commercial capabilities to streamline clinical and regulatory advancement [1].

The licensing agreement grants Avadel exclusive global rights to develop, manufacture, and commercialize valiloxybate worldwide, excluding mainland China, Hong Kong, and Macau. XWPharma is eligible for milestone payments up to $30 million, as well as tiered sales milestone payments and royalties on future net sales. Additionally, Avadel has agreed to pay XWPharma an additional $10 million milestone payment after the first commercial sale in the U.S. for each indication beyond narcolepsy and IH following FDA approval [1].

Avadel's Chief Executive Officer, Greg Divis, commented, "The addition of valiloxybate further reflects our position as a leader in sleep medicine. We are excited to add this innovative therapy to our pipeline." James Huang, Executive Chairman of XWPharma, expressed similar enthusiasm, stating, "We are pleased to enter into this agreement with Avadel, a recognized leader in the advancement of once-at-bedtime oxybate therapy." Anne Marie Morse, D.O., Director of Pediatric Neurology at Geisinger Medical Center, emphasized the potential for valiloxybate to reach and personalize care for more individuals living with sleep disorders [1].

Avadel's existing product, LUMRYZ (sodium oxybate), is 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. The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity for its treatment of cataplexy or EDS in adults and pediatric patients with narcolepsy [1].

This agreement underscores Avadel's commitment to advancing personalized care for individuals with sleep disorders and highlights the company's strategic focus on innovative drug delivery systems.

References:
[1] https://www.morningstar.com/news/globe-newswire/9522879/avadel-pharmaceuticals-strengthens-sleep-medicine-portfolio-with-exclusive-license-of-valiloxybate-from-xwpharma-ltd