Jazz Pharmaceuticals, an Irish specialty biopharmaceutical company focused on unmet medical needs, and Concert Pharmaceuticals, a Lexington, Mass.-based clinical stage biotechnology company, have signed an exclusive license agreement that provides Jazz Pharmaceuticals worldwide rights to develop and commercialize Concert's deuterium-modified sodium oxybate (D-SXB) compounds, including C-10323.   

Sodium oxybate is the active ingredient in Xyrem, a prescription medicine marketed in the U.S. by Jazz Pharmaceuticals to treat two of the key symptoms of narcolepsy. Jazz Pharmaceuticals will have worldwide commercial rights to C-10323, as well as principal responsibility for ongoing development activities. Concert will receive an upfront payment and is eligible to receive additional milestone payments as well as tiered royalties based on potential worldwide sales of any D-SXB products. 

"This collaboration reflects our deep commitment to patients with narcolepsy and to improving their care with safe and effective treatment options," said Jeffrey Tobias, MD, executive vice president of R&D and chief medical officer of Jazz Pharmaceuticals. "Our agreement with Concert on the D-SXB program provides an excellent opportunity for us to explore the potential of deuterium technology in this important area. We look forward to advancing this program into clinical testing in order to further evaluate its potential to provide benefits for patients with narcolepsy."

Roger Tung, Ph.D., president and CEO of Concert Pharmaceuticals, said, "Preclinical data indicate that selective deuterium incorporation can stabilize sodium oxybate in vivo and we are eager to see how this improvement in metabolic properties is reflected in the clinical performance of D-SXB. This collaboration with Jazz Pharmaceuticals allows us to progress our deuterium-modified sodium oxybate program with a partner that has extensive development and commercial experience and is a leader in the narcolepsy field." 

Through Concert's DCE Platform (Deuterated Chemical Entity), Concert has developed a number of deuterium-containing analogs of sodium oxybate. C-10323 has emerged as the lead compound based on in vivo preclinical testing that demonstrated prolonged pharmacokinetic profile and reduced variability as a result of its specific deuterium modification pattern. The companies plan to submit an investigational new drug (IND) application for C-10323 later this year.