DUBLIN—Jazz Pharmaceuticals plc and Concert Pharmaceuticals,Inc., a Lexington, Mass.-based clinical-stage company, have announced thesigning of an exclusive license agreement centered on Concert'sdeuterium-modified sodium oxybate (D-SXB) compounds, including C-10323, itspreclinical drug candidate currently in development for the treatment ofnarcolepsy.
Per the terms of the agreement, Jazz Pharmaceuticals willreceive worldwide commercial rights to C-10323, and will also hold principalresponsibility for its ongoing development. Though no specific financial termswere disclosed, Concert Pharmaceuticals will receive an upfront payment for thelicense, and will also be eligible to receive additional milestone payments aswell as tiered royalties based on worldwide sales of any resulting D-SXBproducts.
"This collaboration reflects our deep commitment to patientswith narcolepsy and to improving their care with safe and effective treatmentoptions," Jeffrey Tobias, M.D., executive vice president of research anddevelopment and chief medical officer of Jazz Pharmaceuticals, said in a pressrelease. "Our agreement with Concert on the D-SXB program provides an excellentopportunity for us to explore the potential of deuterium technology in thisimportant area. We look forward to advancing this program into clinical testingin order to further evaluate its potential to provide benefits for patientswith narcolepsy."
Much of Concert Pharmaceuticals' pipeline consists of drugcandidates developed on its Deuterated Chemical Entity (DCE) Platform, whichuses deuterium, a naturally occurring element that, in select cases, "canimprove upon the metabolic properties of a drug with little or no change in itsintrinsic pharmacology," as the company notes on its website. Several of itscandidates are deuterium-containing analogs of sodium oxybate, of which C-10323has come to the forefront as a lead compound. In preclinical in-vivo testing, the compound demonstrated an extendedpharmacokinetic profile as well as reduced variability. The two companies plansto submit and IND application for the compound later this year.
Sodium oxybate also serves as the active ingredient inXyrem, Jazz Pharmaceuticals' prescription medicine commercialized in the UnitedStates to treat cataplexy (loss of muscle control) and excessive daytimesleepiness, two key symptoms of narcolepsy. The drug first gained U.S. Food andDrug Administration approval in 2002, for the indication of cataplexy, and thenin 2005 for the treatment of excessive daytime sleepiness.
"Preclinical data indicate that selective deuteriumincorporation can stabilize sodium oxybate in vivo and we are eager to see how this improvement inmetabolic properties is reflected in the clinical performance of D-SXB," RogerTung, Ph.D., president and CEO of Concert Pharmaceuticals, noted in astatement. "This collaboration with Jazz Pharmaceuticals allows us to progressour deuterium-modified sodium oxybate program with a partner that has extensivedevelopment and commercial experience and is a leader in the narcolepsy field."
Concert Pharmaceuticals has a number of other partneredcompounds in development in the field of neuroscience. CTP-354 is currently inPhase I development for the treatment of spasticity and neuropathic pain,partnered with Fast Forward, and CTP-786 is being developed in concert withAvanir Pharmaceuticals and is in Phase I development.