Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced that it has concluded an agreement with Denmark's NeuroSearch A/S (OMX: NEUR) to acquire all rights, assets and obligations relating to Huntexil (pridopidine / ACR16), a drug candidate being developed for the symptomatic treatment of hand movement, balance and gait disturbances in Huntington disease. Under the agreement, Teva will pay NeuroSearch $26 million over a period of at least six months. Teva added that regulatory and commercialization milestone payments may result in additional funding for NeuroSearch.
Teva said that previous trials in the US, Canada and EU demonstrated significant symptomatic relief for patients with Huntington disease including improved hand movements, gait and balance. These results were observed without any side effects such as sedation and depression seen with other therapies such as neuroleptics and tetrabenazine. Teva believes that Huntexil will, if used as a symptomatic agent, make a real difference to the quality of life for patients suffering from Huntington disease.
Teva president of global R&D and chief scientific officer Dr. Michael Hayden, who is one of the world’s leading experts on Huntington disease said, “Based on the clinical trial evidence to date, we believe Huntexil holds promise for symptomatic relief for Huntington disease and merits additional study in late-stage clinical development. Teva has a broad commitment to find new approaches to managing devastating CNS diseases, such as Huntington disease. This promising development for Teva is just one example of our covenant with patients to develop medicines to improve their quality of life all around the world.”
Huntexil is an oral small molecule dopamine D2 stabilizer being developed for the symptomatic treatment of non-choreic motor disorders, including Huntington disease. Huntington disease affects about one person in 10,000 in North America and Europe and generally results in death within 15 to 25 years of diagnosis.
Teva said that it intends to design and complete new clinical studies of Huntexil to assess its potential for symptomatic relief of Huntington disease. Advanced-stage clinical studies of Huntexil conducted in the US, EU and Canada in patients with the disease demonstrated a significant treatment effect on Total Motor Score, but failed to meet the primary endpoint (Modified Total Motor score). Data from the clinical studies were presented to the US Food and Drug Administration (FDA) and the European Medical association (EMA) in the first half of 2011, but were found insufficient to file for marketing approval.
Huntington disease is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration, and behavioral and/or psychological problems. The classic onset of the disease's symptoms typically occurs in middle age, but the disease also manifests in children and the elderly. Disease progression is characterized by a gradual decline in motor control, cognition, and mental stability and generally results in death within 15‐25 years of clinical diagnosis.
Published by Globes [online], Israel business news - www.globes-online.com - on September 30, 2012
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