By a News Reporter-Staff News Editor at Biotech Week -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Aerial BioPharma, LLC (Aerial) announced that the companies have signed a definitive agreement under which Jazz Pharmaceuticals has acquired rights to ADX-N05, a novel compound in clinical development for the treatment of excessive daytime sleepiness in patients with narcolepsy (see also Jazz Pharmaceuticals plc).
Under the agreement, a subsidiary of Jazz Pharmaceuticals has acquired worldwide development, manufacturing and commercial rights to ADX-N05, other than in certain countries in Asia where SK Biopharmaceuticals Co., Ltd (SK) retains rights(1). Under the agreement, 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 chief executive officer of Jazz Pharmaceuticals plc. "This acquisition supports our mission to improve care for patients with serious medical conditions. We look forward to accelerating the development of ADX-N05 as part of our long-term strategy of building a development pipeline and expanding our portfolio of commercial products through targeted investments that offer potential new treatment options for patients, with the objective of creating significant value for our shareholders."
"The addition of ADX-N05 to our development pipeline is an excellent strategic fit for Jazz given our strong clinical expertise in sleep and narcolepsy," said Jeffrey Tobias, MD, executive vice president of research and development and chief medical officer of Jazz Pharmaceuticals. "The ADX-N05 Phase 2b results, announced by Aerial in October 2013, demonstrated a robust effect on excessive daytime sleepiness in patients with narcolepsy. Given ADX-N05's demonstrated wake-promoting properties in pre-clinical and clinical studies, including the Phase 2b 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 3 clinical trials. We look forward to discussing our development plans with the U.S. Food and Drug Administration and initiating our Phase 3 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(2,3). Narcolepsy is a chronic, debilitating, orphan condition that impacts approximately 157,000 people in the United States(4). 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 OSA(5).
Keywords for this news article include: Jazz Pharmaceuticals plc, Treatment, Acquisitions and Mergers, Mergers and Acquisitions, Clinical Trials and Studies.
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