Avadel Pharmaceuticals has licensed valiloxybate from XWPharma Ltd.
Key takeaways:
- Avadel gained exclusive global rights (excluding mainland China, Hong Kong, and Macau) to develop and commercialize valiloxybate from XWPharma.
- Valiloxybate is designed as a once-at-bedtime GABA-B receptor agonist that avoids sodium and artificial sweeteners.
- Initial pharmacokinetic studies are slated for late 2025, with a pivotal trial planned for 2026.
- Preliminary data suggest potential bioequivalence to Avadel’s FDA-approved once-nightly oxybate LUMRYZ, supporting a possible streamlined regulatory path.
Avadel Pharmaceuticals plc has entered into an exclusive global license agreement with XWPharma Ltd to develop and commercialize valiloxybate, a GABA-B receptor agonist, for all indications, including the treatment of sleep disorders, such as narcolepsy and idiopathic hypersomnia (IH). Avadel is the marketer of LUMRYZ (sodium oxybate), which is US Food and Drug Administration (FDA) approved for people ages 7 and older with narcolepsy, a once-nightly treatment for cataplexy and excessive daytime sleepiness.
Valiloxybate has been designed to deliver the therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free, and artificial sweetener-free formulation.
“The broad adoption of LUMRYZ demonstrates the transformative benefits that a once-at-bedtime oxybate therapy can bring to patients and their families,” says Greg Divis, CEO of Avadel Pharmaceuticals, in a release. “As an innovator in the treatment of sleep disorders, we are excited to add valiloxybate to our pipeline.”
“Oxybates are transformational medications for people living with narcolepsy and IH, as they provide proven durable efficacy and address the 24-hour-a-day nature of these disorders. While sodium sensitivity can affect a small proportion of these patients, all patients deserve the benefit of personalized care and the option of a no sodium, once-at-bedtime dosing solution. I believe the additional option of once-at-bedtime, no sodium valiloxybate will further expand utilization and, most importantly, benefit more patients,” says Anne Marie Morse, DO, director of pediatric neurology at Geisinger Medical Center at Janet Weis Children’s Hospital, in a release.
Expected Timeline for Valiloxybate
Avadel expects to advance its valiloxybate formulation into an initial pharmacokinetic study in the fourth quarter of 2025, followed by a pivotal pharmacokinetic trial in the second half of 2026.
Valiloxybate’s properties enable extended-release delivery, offering a potentially differentiated profile from traditional oxybate therapies.
Preliminary clinical data suggest the potential for bioequivalence to be established between valiloxybate and Avadel’s LUMRYZ. Accordingly, successful completion of the pharmacokinetic clinical program and FDA alignment with Avadel’s regulatory approach could potentially result in a streamlined and capital-efficient development pathway for valiloxybate.
The program is expected to benefit from Avadel’s existing infrastructure and commercial capabilities, potentially allowing for efficient clinical and regulatory advancement via a bioequivalence pathway as well as a streamlined commercial launch, if approved.
License Agreement Terms
Under the terms of the agreement, XWPharma grants Avadel an exclusive global license to develop, manufacture, and commercialize valiloxybate worldwide, excluding mainland China, Hong Kong, and Macau. XWPharma will receive an upfront payment of $20 million from Avadel and is eligible to receive milestone payments associated with certain development milestones of up to $30 million.
Avadel has also agreed to pay XWPharma up to an aggregate of $155 million in performance-based tiered sales milestones for the first achievement of annual net sales up to $750 million. For the first achievement of annual net sales exceeding $750 million and up to $3.5 billion, Avadel will pay XWPharma certain performance-based sales milestone payments equal to 10% of each of those sales milestones. In addition, Avadel has agreed to pay tiered royalties ranging from high-single digit to mid-teens, as a percentage of net sales of the licensed products, and also an additional $10 million milestone payment after the first commercial sale in the United States for each indication beyond narcolepsy and IH following FDA approval for same.
In a release, James Huang, executive chairman of XWPharma, says, “We are pleased to enter into this licensing agreement with Avadel, a recognized leader in the clinical and commercial advancement of once-at-bedtime oxybate therapy and the ideal partner to progress valiloxybate to market. We are excited for the opportunity to offer access to this innovative therapy to a broad population of those living with sleep disorders.”
