JERUSALEM—Teva Pharmaceutical Industries Ltd. has announcedthe completion of an Asset Transfer Agreement with NeuroSearch A/S, a Danishpharmaceutical company with a focus in central nervous system diseases. Underthe agreement, Teva will purchase all rights, assets and obligations related toHuntexil (pridopidine/ACR16), a drug candidate in development for thesymptomatic treatment of hand movement, balance and gait disturbances in peoplesuffering from Huntington disease.
Per the terms of the agreement, NeuroSearch will receive 150Danish kroner (approximately $26 million) over a period of at least six months,and is eligible for regulatory and commercialization milestone payments aswell.
Huntexil is an oral small-molecule dopamine D2 stabilizer,and is currently in development "for the symptomatic treatment of non-choreicmotor disorders," which includes Huntington disease.
So far, trials of Huntexil in the United States, Canada andthe European Union have shown the compound to provide significant symptomaticrelief for Huntington disease patients, including improvement in handmovements, gait and balance. No side effects such as sedation or depression,which occur in therapies such as tetrabenazine and neuroleptics, have beenobserved.
"Based on the clinical trial evidence to date, we believeHuntexil holds promise for symptomatic relief for HD and merits additionalstudy in late-stage clinical development," Michael R. Hayden, M.D., Ph.D.,president of Global R&D and chief scientific officer of Teva as well as aleading expert on Huntington disease, said in a press release. "Teva has abroad commitment to find new approaches to managing devastating CNS diseases,such as Huntington disease. This promising development for Teva is just oneexample of our covenant with patients to develop medicines to improve theirquality of life all around the world."
Moving forward, Teva plans to design and conduct additionalclinical studies of the drug to determine its potential for symptomatic reliefof Huntington disease. While previous late-stage clinical studies have beenconducted in Huntington disease patients in the United States, Canada and theEuropean Union, they failed to meet the primary endpoint (Modified Total Motorscore) despite demonstrating a significant effect on Total Motor Score.Clinical data presented to the U.S. Food and Drug Administration and theEuropean Medicines Agency in the first half of last year were found to beinsufficient to support filing for marketing approval.
Huntington disease is a neurodegenerative disease known forcognitive decline, behavioral and/or psychological problems and uncoordinated,uncontrollable movement. A genetic disease, Huntington disease is transmittedby autosomal dominant inheritance due to a defective gene on chromosome 4.Symptomatic onset generally occurs in middle age, though it is also known topresent in children and the elderly. Disease progression consists of ongoingdeterioration in motor control, cognition and mental stability, and the diseasegenerally leads to death within 15 to 25 years of original diagnosis.
Approximately one in 10,000 people are affected by Huntington disease in NorthAmerica and Europe. Currently, the only marketed product for Huntington diseaseis tetrabenazine, which, in addition to having no effect on non-choreicsymptoms and disease progression, is known to have serious side effects such asdepression and suicidal tendencies.
SOURCE: Teva press release