Sleep Diagnosis and Therapy

Official Publication of the American Sleep and Breathing Academy

Jazz Pharma Acquires Rights to Late Stage Investigational Compound for Excessive Daytime Sleepiness

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Jazz Pharma a specialty pharmaceutical company who have successfully commercialized the drug Xyrem, is betting $397M on a new narcolepsy drug from Aerial BioPharma. They will pay out $125 million up front and up to $272 million in milestones for ADX-N05, Aerial’s mid-stage drug for excessive daytime sleepiness in patients with narcolepsy. In October, the North Carolina biotech unveiled positive results from a 93-patient Phase IIb trial and started looking around for a buyer to take the drug into Phase III. Now, Jazz plans to do just that in short order, leveraging the same expertise it used to develop the narcolepsy treatment Xyrem.

“Given ADX-N05’s demonstrated wake-promoting properties in preclinical and clinical studies, including the Phase IIb results, we believe ADX-N05 could also 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,” Chief Medical Officer Jeffrey Tobias said in a statement.

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 sleepiness2,3.  Narcolepsy is a chronic, debilitating, orphan condition that impacts approximately 157,000 people in the United States4.  Less than half of the estimated 157,000 people living with narcolepsy in the United States 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 are often inadequately treated with available wake-promoting agents.  In the United States, approximately 500,000 patients receive wake-promoting therapies for excessive daytime sleepiness associated with OSA5.

 

 

References:

  1. SK has retained rights to ADX-N05 in Korea, Japan, China, Taiwan, Singapore, Indonesia, India,Philippines, Thailand, Malaysia, Vietnam, Hong Kong.
  2. NA Antic et al. The effect of CPAP in normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011: Jan 1; 34(1):111-9.
  3. C Guilleminault et al. Problems associated with switch to modafinil – a novel alerting agent in narcolepsy.Eur J Neurol.  2000 Jul; 7(4):381-4.
  4. CR Baumann et al. Narcolepsy: Pathophysiology, Diagnosis, and Treatment.  Springer: NY 2011.
  5. SH Launois et al. Current Opinion in Pulmonary Medicine. 19(6):601-608, November 2013.

Source: Jazz Pharmaceuticals