Jazz Pharmaceuticals and Aerial BioPharma have signed a definitive agreement under which Jazz has acquired rights to ADX-N05, a novel compound in clinical development for the treatment of excessive daytime sleepiness in patients with narcolepsy.

A subsidiary of Jazz has acquired worldwide development, manufacturing and commercial rights to ADX-N05, other than in certain countries in Asia where SK Biopharmaceuticals retains rights. Aerial will receive an upfront payment of $125 million.  Aerial and SK are eligible to receive milestone payments based on development, regulatory and sales milestones and tiered royalties based on potential future sales.

"ADX-N05 is a strong fit with our specialty focus and continues our commitment to develop and bring to market differentiated treatments for patients with sleep-related disorders," said Bruce Cozadd, chairman and CEO of Jazz.  

"The addition of ADX-N05 to our development pipeline is an excellent strategic fit for Jazz given our strong clinical experience in sleep and narcolepsy," said Jeffrey Tobias, M.D., executive vice president of R&D and chief medical officer of Jazz. "The ADX-N05 phase IIb results, announced by Aerial in October, demonstrated a robust effect on excessive daytime sleepiness in patients with narcolepsy. Given ADX-N05's demonstrated wake-promoting properties in preclinical and clinical studies, including the phase IIb results, we believe ADX-N05 also could potentially benefit patients whose excessive daytime sleepiness stems from other causes, such as obstructive sleep apnea, where we also intend to pursue phase III clinical trials. We look forward to discussing our development plans with the FDA and initiating our phase III clinical program for ADX-N05 as quickly as possible."

Excessive daytime sleepiness is a common symptom for patients with narcolepsy and obstructive sleep apnea (OSA).  Despite current therapies, many patients with narcolepsy and OSA continue to experience excessive daytime sleepiness. Narcolepsy is a chronic, debilitating, orphan condition that impacts approximately 157,000 people in the U.S.

Less than half of the estimated 157,000 people living with narcolepsy in the U.S. have been properly diagnosed and approximately 50,000 patients receive wake-promoting therapies. OSA is a serious chronic sleep disorder in which breathing repeatedly stops and starts during sleep.  People living with excessive daytime sleepiness in narcolepsy and OSA often are inadequately treated with available wake-promoting agents.  In the U.S., approximately 500,000 patients receive wake-promoting therapies for excessive daytime sleepiness associated with OSA(5).