NeuroSearch achieves approval for HuntexilTM as brand name for pridopidine-
Copenhagen, 24 August 2009 – NeuroSearch (NEUR) announces today that the European Medicines Agency (EMEA) has approved HuntexilTM as the new trade name for pridopidine (previously designated ACR16), an entirely new medical approach for the treatment of Huntington’s disease.
Planned for market launch in 2011, HuntexilTM (pridopidine) is in late stage clinical development as a novel treatment for Huntington’s disease. NeuroSearch is committed to developing new and effective therapies for speciality disease areas of significantly unmet medical needs, and developed Huntexil™ to address the limited treatment options currently available for Huntington’s patients and their treating physicians. To date, clinical studies have shown HuntexilTM to have promising effect on a number of the serious symptoms associated with Huntington’s disease. This includes, in particular, a significant improvement in patients’ ability to perform voluntary movements and the ability to walk with fewer incidents of falls, leading to a better daily functioning and quality of life.
“At NeuroSearch, we are highly committed to our HuntexilTM programme aiming for registration and marketing of the product in 2011 as one of the first specific treatments for patients with Huntington’s disease. The estimated total number of Huntington’s patients worldwide is approximately 100,000, and no effective treatment is currently available for this severe disease. HuntexilTM is one of the only new Huntington’s drugs in late-stage development,” commented Flemming Pedersen, CEO of NeuroSearch.
Joakim Tedroff, Chief Medical Officer of NeuroSearch Sweden, added:
“We are very excited about the prospects for our product. Huntington’s disease is a devastating neurodegenerative disease causing progressive loss of previously acquired functions. The results NeuroSearch have generated with HuntexilTM so far indicate that this drug represents a unique therapeutic principle with the potential to ameliorate some of the most disabling symptoms of the disease. It is our hope that Huntexil™ will help patients regain abilities lost by the disease, making their everyday life easier.”
The pivotal development programme for HuntexilTM comprises two ongoing clinical studies; a six-month European Phase III study, MermaiHD, and a three-month North American study, HART. Both studies are randomised, double-blind and placebo-controlled evaluating the efficacy, safety and tolerability of two different HuntexilTM dosing regimens. NeuroSearch has finished recruiting patients to MermaiHD which, with more than 430 patients enrolled, is the largest European Huntington’s disease study to date. The HART study is still recruiting.
Both studies are progressing well, and HuntexilTM appears to be well-tolerated. To date, approximately 90% of the patients who have completed randomised treatment in MermaiHD have chosen to continue treatment with HuntexilTM in a six month, open-label extension study.
Huntexil™ has been registered as a new trademark in Denmark and NeuroSearch is now seeking registration of HuntexilTM in other relevant jurisdictions, including the European Union and North America.
Copenhagen, 24 August 2009 – NeuroSearch (NEUR) announces today that the European Medicines Agency (EMEA) has approved HuntexilTM as the new trade name for pridopidine (previously designated ACR16), an entirely new medical approach for the treatment of Huntington’s disease.
Planned for market launch in 2011, HuntexilTM (pridopidine) is in late stage clinical development as a novel treatment for Huntington’s disease. NeuroSearch is committed to developing new and effective therapies for speciality disease areas of significantly unmet medical needs, and developed Huntexil™ to address the limited treatment options currently available for Huntington’s patients and their treating physicians. To date, clinical studies have shown HuntexilTM to have promising effect on a number of the serious symptoms associated with Huntington’s disease. This includes, in particular, a significant improvement in patients’ ability to perform voluntary movements and the ability to walk with fewer incidents of falls, leading to a better daily functioning and quality of life.
“At NeuroSearch, we are highly committed to our HuntexilTM programme aiming for registration and marketing of the product in 2011 as one of the first specific treatments for patients with Huntington’s disease. The estimated total number of Huntington’s patients worldwide is approximately 100,000, and no effective treatment is currently available for this severe disease. HuntexilTM is one of the only new Huntington’s drugs in late-stage development,” commented Flemming Pedersen, CEO of NeuroSearch.
Joakim Tedroff, Chief Medical Officer of NeuroSearch Sweden, added:
“We are very excited about the prospects for our product. Huntington’s disease is a devastating neurodegenerative disease causing progressive loss of previously acquired functions. The results NeuroSearch have generated with HuntexilTM so far indicate that this drug represents a unique therapeutic principle with the potential to ameliorate some of the most disabling symptoms of the disease. It is our hope that Huntexil™ will help patients regain abilities lost by the disease, making their everyday life easier.”
The pivotal development programme for HuntexilTM comprises two ongoing clinical studies; a six-month European Phase III study, MermaiHD, and a three-month North American study, HART. Both studies are randomised, double-blind and placebo-controlled evaluating the efficacy, safety and tolerability of two different HuntexilTM dosing regimens. NeuroSearch has finished recruiting patients to MermaiHD which, with more than 430 patients enrolled, is the largest European Huntington’s disease study to date. The HART study is still recruiting.
Both studies are progressing well, and HuntexilTM appears to be well-tolerated. To date, approximately 90% of the patients who have completed randomised treatment in MermaiHD have chosen to continue treatment with HuntexilTM in a six month, open-label extension study.
Huntexil™ has been registered as a new trademark in Denmark and NeuroSearch is now seeking registration of HuntexilTM in other relevant jurisdictions, including the European Union and North America.
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