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Acorda annonce que le Comité européen recommande l'approbation conditionnelle de commercialisation de AmpyraLundi 23 mai 2011Le Comité des médicaments à usage humain (CHMP) de l'Agence européenne des médicaments (EMA) a recommandé une autorisation conditionnelle de commercialisation de Ampyra (fampridine à libération prolongée 10 mg) pour l'amélioration de la marche chez les patients adultes atteints de Sclérose en plaques. Ce traitement par voie orale a été développé et est commercialisé par Acorda Therapeutics aux États-Unis sous le nom commercial Ampyra (dalfampridine). En dehors des Etats-Unis, Ampyra est développé et commercialisé par Biogen Idec en vertu d'un accord de licence avec Acorda. Sur la base de la recommandation du CHMP, Biogen Idec prévoit qu'une autorisation conditionnelle de commercialisation pour Ampyra devrait être accordé en Europe dans les 67 jours."Ampyra est le premier et le seul médicament indiqué pour améliorer la marche chez les personnes atteintes de SEP, et a montré être efficace dans tous les principaux types de Sclérose en plaques. Plusieurs milliers de personnes atteintes de SEP ont connu une amélioration dans leur capacité de marche après le début du traitement avec Ampyra, et nous sommes heureux que la décision du CHMP permettra bientôt aux patients en Europe d'avoir accès à ce médicament », a déclaré le Dr. Ron Cohen, PDG d’Acorda. "Nous continuerons à travailler avec notre partenaire, Biogen Idec, pour que cette thérapie soit disponible en Europe et sur d'autres marchés à travers le monde" a-t-il ajouté. En mai 2011, Ampyra a été approuvé pour une utilisation en Australie par l'Australian Therapeutic Goods Administration (ATGA). En vertu des dispositions de l'autorisation conditionnelle de commercialisation pour Ampyra, Biogen Idec sera tenu de fournir des données supplémentaires au CHMP. L’autorisation conditionnelle de commercialisation sera renouvelable annuellement. Ampyra a été approuvé par la US Food and Drug Administration le 22 Janvier 2010 selon les données de tolérance et d'efficacité d’essais cliniques qui ont inclus plus de 2000 personnes. Le médicament a été lancé aux États-Unis le 1er Mars 2010 et, à compter de Décembre 2010, environ 7000 médecins américains avaient prescrit Ampyra à environ 40.000 personnes atteintes de SEP. Acorda a conclu une collaboration avec Biogen Idec en Juin 2009, pour développer et commercialiser Ampyra sur tous les marchés en dehors des États-Unis.(…)=========================== :arrow: TEXTE ORIGINAL EN ANGLAIS ===========================Acorda says European committee recommends conditional marketing approval of AmpyraMonday, May 23, 2011The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended conditional marketing authorization of Fampyra (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale of 4-7). This oral therapy was developed and is commercialized by Acorda Therapeutics, Inc. in the United States under the trade name Ampyra (dalfampridine) Extended Release tablets, 10 mg. Fampyra is being developed and marketed by Biogen Idec outside the United States under a licensing agreement from Acorda.Based on the CHMP recommendation, Biogen Idec expects that a conditional marketing authorization for Fampyra should be granted within 67 days.“Ampyra is the first and only medication indicated to improve walking in people with MS, and has been shown to be effective in all major types of MS. Many thousands of people with MS have experienced improvement in their walking ability after initiating treatment with Ampyra, and we are pleased that the CHMP decision should soon allow patients in Europe to have access to this medication,” said Ron Cohen, MD, president and CEO, Acorda. “We will continue working with our partner, Biogen Idec, to make this therapy available in Europe and other markets worldwide” he added.In May 2011, Fampyra was approved for use in Australia by the Australian Therapeutic Goods Administration (ATGA).As part of the license agreement between Acorda and Biogen Idec, European Medicines Agency (EMA) approval in Europe triggers a $25 million milestone payment to Acorda from Biogen Idec. Acorda may receive additional payments of up to $375 million based on the successful achievement of future regulatory and sales milestones. Under Acorda's existing agreements with Elan Pharma International Limited, a subsidiary of Elan Corporation plc, Acorda will pay Elan seven percent of the milestone payments that Acorda receives from Biogen Idec.Acorda will also receive a double-digit royalty from Biogen Idec based on net sales of Fampyra in all markets outside the United States.Under the provisions of the conditional marketing authorization for Fampyra, Biogen Idec will be required to provide further data to the CHMP. A conditional marketing authorization is renewable annually.Ampyra was approved by the US Food and Drug Administration on January 22, 2010 based on safety and efficacy data from 56 clinical trials that enrolled more than 2,000 people, over 1,000 of whom were diagnosed with MS. The drug was launched commercially in the US on March 1, 2010 and, as of December 2010, approximately 7,000 US physicians had prescribed Ampyra to approximately 40,000 people with MS. Acorda entered into a collaboration with Biogen Idec in June 2009 in which Biogen Idec licensed rights from Acorda to develop and commercialize fampridine in all markets outside the United States.Ampyra can cause seizures; the risk of seizures increases with increasing Ampyra doses. It is contraindicated in patients with a prior history of seizure. If seizure occurs, discontinue the use of Ampyra.Ampyra is contraindicated in patients with moderate or severe renal impairment (CrClless-than or equal to 50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown, but Ampyra plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with it.Ampyra should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.Urinary tract infections were reported more frequently as adverse reactions in patients receiving Ampyra 10 mg twice daily compared to placebo.The most common adverse events (incidence greater-than or equal to 2% and at a rate greater than the placebo rate) for Ampyra in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.Ampyra is a potassium channel blocker approved as a treatment to improve walking in patients with Multiple Sclerosis (MS). This was demonstrated by an increase in walking speed. It was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine, and remains known by that name outside the US. In laboratory studies, dalfampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged.Ampyra is being developed and commercialized in the United States by Acorda Therapeutics, and by Biogen Idec in markets outside the US based on a licensing agreement with Acorda. It is manufactured globally by Elan based on a supply agreement with Acorda. Ampyra is now available by prescription in the United States.Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders.Source : http://www.pharmabiz.com/PrintArticle.aspx?aid=63011&sid=2
Mardi 25 mai 2010(…)A propos de Acorda TherapeuticsAcorda Therapeutics est une société de biotechnologie qui développe des thérapies pour la Sclérose en plaques, les lésions de la moelle épinière et d'autres troubles du système nerveux. Les produits commercialisés actuellement par la société comprennent AMPYRA™ (dalfampridine), un inhibiteur des canaux potassium approuvé comme traitement pour améliorer la marche chez les patients atteints de Sclérose en plaques (SEP) et qui a démontré une amélioration de la vitesse de marche, et ZANAFLEX capsules ® (tizanidine chlorhydrate), un médicament à courte durée d'action pour la gestion de la spasticité. La Société comprend aussi un certain nombre de produits en développement pour le traitement, la régénération et la réparation de la moelle épinière et du cerveau.(…)=========================== :arrow: TEXTE ORIGINAL EN ANGLAIS ===========================Tuesday, May 25, 2010(…)About Acorda TherapeuticsAcorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and other nervous system disorders. The Company's marketed products include AMPYRA(TM) (dalfampridine), a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS); this was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES(R) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.(…)Source : http://www.foxbusiness.com/story/markets/industries/health-care/acorda-therapeutics-chief-scientific-officer-andrew-r-blight-deliver-keynote
Biogen Idec et Acorda Therapeutics annoncent un accord de collaboration pour développer et commercialiser la Fampridine-SR pour la Sclérose en plaque sur les marchés en dehors des États-Unis.1er juillet 2009 CAMBRIDGE, Ma. & HAWTHORNE, N.Y. - Biogen Idec et Acorda Therapeutics ont annoncé aujourd'hui qu'ils ont conclu une collaboration et un accord de licence exclusifs de développer et commercialiser la Fampridine-SR, une thérapie pour la sclérose en plaques (SEP), sur les marchés en dehors des Etats-Unis. La Fampridine-SR est un nouveau médicament oral développé pour améliorer la capacité de marche chez les personnes avec une SEP. Les parties ont également conclu un accord mutuel de fourniture. La transaction représente une sous-licence d'un accord de licence existant entre Acorda et Elan Pharma International Limited, une filiale de Elan Corporation.En vertu de l'accord, Biogen Idec commercialisera la Fampridine-SR et tous les produits aminopyridine développés aux termes de l'accord sur les marchés du monde entier et aura également la responsabilité des activités de développements cliniques de la Fampridine-SR sur ces marchés. Acorda recevra un paiement de $110 millions et des paiements complémentaires jusqu'à $400 millions basés sur l'accomplissement des futures étapes de normalisation et de ventes. Les parties peuvent également effectuer de futures activités de développement conjoint dans le cadre d'un arrangement de partage des frais.(…)=========================== :arrow: TEXTE ORIGINAL EN ANGLAIS ===========================Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement to Develop and Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.Wed, 01 Jul 2009 10:05:08 GMTCAMBRIDGE, Ma. & HAWTHORNE, N.Y. - (Business Wire) Biogen Idec (NASDAQ:BIIB) and Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that they have entered into an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR, a multiple sclerosis (MS) therapy, in markets outside the United States. Fampridine-SR is a novel, oral sustained-release compound being developed to improve walking ability in people with MS. The parties have also entered into a related supply agreement. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan Pharma International Limited, a subsidiary of Elan Corporation plc (NYSE:ELN).Under the terms of the agreement, Biogen Idec will commercialize Fampridine-SR and any aminopyridine products developed under the agreement in ex-U.S. markets worldwide and will also have responsibility for regulatory activities and future clinical development of Fampridine-SR in those markets. Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones. Biogen Idec will make tiered, double-digit royalty payments to Acorda on ex-U.S. sales, and, in addition, the consideration that Biogen Idec pays for products will reflect all amounts due from Acorda to Elan for ex-US sales, including royalties owed. The parties can also carry out future joint development activities under a cost-sharing arrangement.(…)Source : http://www.earthtimes.org/articles/show/biogen-idec-and-acorda-therapeutics,878942.shtml