公开(公告)号：US20140199387A1

公开(公告)日：2014-07-17

申请号：US14213321

申请日：2014-03-14

Applicant: Forward Pharma A/S

Inventor： Henrik NILSSON ,  Florian SCHOENHARTING ,  Bernd W. MUELLER ,  Joseph R. ROBINSON

IPC: A61K9/48 ,  A61K9/28 ,  A61K31/225

CPC classification number: A61K31/225 ,  A61K9/0053 ,  A61K9/14 ,  A61K9/167 ,  A61K9/20 ,  A61K9/2013 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2077 ,  A61K9/2081 ,  A61K9/28 ,  A61K9/2846 ,  A61K9/2853 ,  A61K9/2866 ,  A61K9/48 ,  A61K9/4808 ,  A61K9/4891 ,  A61K9/50 ,  A61K9/5042 ,  A61K9/5047 ,  A61K9/5084 ,  A61K31/215 ,  A61K31/22 ,  A61K45/06 ,  A61K2300/00

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

公开(公告)号：US20140193495A1

公开(公告)日：2014-07-10

申请号：US14209480

申请日：2014-03-13

Applicant: FORWARD PHARMA A/S

Inventor： Henrik NILSSON ,  Florian SCHOENHARTING ,  Bernd W. MUELLER ,  Joseph R. ROBINSON

IPC: A61K31/225 ,  A61K9/48 ,  A61K9/20 ,  A61K9/28

CPC classification number: A61K31/225 ,  A61K9/0053 ,  A61K9/14 ,  A61K9/167 ,  A61K9/20 ,  A61K9/2013 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2077 ,  A61K9/2081 ,  A61K9/28 ,  A61K9/2846 ,  A61K9/2853 ,  A61K9/2866 ,  A61K9/48 ,  A61K9/4808 ,  A61K9/4891 ,  A61K9/50 ,  A61K9/5042 ,  A61K9/5047 ,  A61K9/5084 ,  A61K31/215 ,  A61K31/22 ,  A61K45/06 ,  A61K2300/00

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract translation: 本发明涉及包含富马酸酯作为活性物质的控释药物组合物。 该组合物适合用于治疗例如儿童。 牛皮癣或其他过度增生，炎性或自身免疫性疾病，并被指定以受控的方式释放富马酸酯，使得可以避免在口服给药时在胃肠道内的局部高浓度的活性物质，从而能够减少胃 - 肠道相关副作用。

公开(公告)号：EP2879672B1

公开(公告)日：2018-04-11

申请号：EP13745073.0

申请日：2013-08-02

Applicant: Forward Pharma A/S

Inventor： TERWEY, Theis ,  RUPP, Roland ,  ANDERSEN, Peder M.

IPC: A61K31/215 ,  A61K31/275 ,  A61K9/00 ,  A61P29/00 ,  A61K31/137 ,  A61K31/47

CPC classification number: A61K31/225 ,  A61K9/209 ,  A61K9/28 ,  A61K31/137 ,  A61K31/215 ,  A61K31/275 ,  A61K31/277 ,  A61K31/47 ,  A61K31/4704 ,  A61K2300/00

Abstract: The present invention relates to a method of treating MS in a human patient in need of such treatment and comprises administering to said patient a combination therapy in a single oral dosage form (e.g. a tablet or capsule) of dimethylfumarate and one agent selected from teriflunomide (or its prodrug leflunomide), fingolimod and laquinimod. This combination is more effective than the single agents alone and/or has reduced side effects and better tolerability than the single agents alone and/or can be given in a reduced frequency. Moreover, the present invention is directed to a pharmaceutical composition suitable for the oral treatment of multiple sclerosis consisting of dimethylfumarate and one agent selected from teriflunomide, fingolimod and laquinimod as active ingredients and one or more pharmaceutically acceptable excipients.

公开(公告)号：EP3090733A1

公开(公告)日：2016-11-09

申请号：EP16000993.2

申请日：2010-01-08

Applicant: Forward Pharma A/S

Inventor： Nilsson, Henrik ,  Rupp, Roland

IPC: A61K9/28 ,  A61K31/215 ,  A61P17/06 ,  A61K9/20 ,  A61K31/225

CPC classification number: A61K9/28 ,  A61K9/2054 ,  A61K9/2846 ,  A61K9/2866 ,  A61K9/2886 ,  A61K31/215 ,  A61K31/225

Abstract: A pharmaceutical formulation comprising an erosion matrix comprising one or more fumaric acid esters as well as one or more rate-controlling agents, wherein erosion of said erosion matrix permits controlled release of said fumaric acid ester(s).

Abstract translation: 包含含有一种或多种富马酸酯的腐蚀基质以及一种或多种速率控制剂的药物制剂，其中所述侵蚀基质的侵蚀允许所述富马酸酯的受控释放。

公开(公告)号：EP3038605A1

公开(公告)日：2016-07-06

申请号：EP14755672.4

申请日：2014-08-26

Applicant: Forward Pharma A/S

Inventor： GALETZKA, Christin ,  RUNDFELDT, Chris ,  RUPP, Roland ,  ANDERSEN, Peder M.

IPC: A61K9/28 ,  A61K31/225

CPC classification number: A61K31/225 ,  A61K9/0053 ,  A61K9/2009 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2054 ,  A61K9/28 ,  A61K9/2846

Abstract: The present invention relates to pharmaceutical compositions containing dimethyl fumarate (DMF), More specifically, the present invention relates to a pharmaceutical composition for oral use in treating hyperproliferative, inflammatory or autoimmune disorders by administering a low daily dosage in the range of 410 mg±5% or 400 mg±5% dimethyl fumarate, wherein the pharmaceutical formulation is in the form of an erosion matrix tablet.

Abstract translation: 本发明涉及含有富马酸二甲酯（DMF）更具体地，本发明涉及用于口服使用的药物组合物中的范围内管理的低日剂量治疗过度增殖，炎性或自身免疫性疾病的药物组合物410毫克±5 ％或400毫克富马酸±5％二甲基，worin所述药物制剂是一种侵蚀基质片剂的形式。

公开(公告)号：EP2792349A3

公开(公告)日：2014-12-17

申请号：EP14172396.5

申请日：2005-10-07

Applicant: Forward Pharma A/S

Inventor： Nilsson, Henrik ,  Schönharting, Florian ,  Müller, Bernd, W. ,  Robinson, Joseph, R.

IPC: A61K9/20

CPC classification number: A61K31/225 ,  A61K9/0053 ,  A61K9/14 ,  A61K9/167 ,  A61K9/20 ,  A61K9/2013 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2077 ,  A61K9/2081 ,  A61K9/28 ,  A61K9/2846 ,  A61K9/48 ,  A61K9/4808 ,  A61K9/4891 ,  A61K9/50 ,  A61K9/5042 ,  A61K9/5047 ,  A61K9/5084 ,  A61K31/215 ,  A61K31/22 ,  A61K45/06 ,  A61K2300/00

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising a fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract translation: 本发明涉及包含作为活性物质的富马酸酯的控释药物组合物。 该组合物适用于治疗例如， 牛皮癣或其他过度增殖性，炎性或自身免疫性疾病，并且被指定以受控方式释放富马酸酯，从而避免口服给药时局部高浓度的胃肠道内的活性物质，从而能够减少胃 肠道相关的副作用。

公开(公告)号：EP2801355A1

公开(公告)日：2014-11-12

申请号：EP14172398.1

申请日：2005-10-07

Applicant: Forward Pharma A/S

Inventor： Nilsson, Henrik ,  Schönharting, Florian ,  Müller, Bernd, W. ,  Robinson, Joseph, R.

IPC: A61K9/20 ,  A61K9/50

CPC classification number: A61K31/225 ,  A61K9/0053 ,  A61K9/14 ,  A61K9/167 ,  A61K9/20 ,  A61K9/2013 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2077 ,  A61K9/2081 ,  A61K9/28 ,  A61K9/2846 ,  A61K9/48 ,  A61K9/4808 ,  A61K9/4891 ,  A61K9/50 ,  A61K9/5042 ,  A61K9/5047 ,  A61K9/5084 ,  A61K31/215 ,  A61K31/22 ,  A61K45/06 ,  A61K2300/00

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising a fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

公开(公告)号：EP2692344A1

公开(公告)日：2014-02-05

申请号：EP12187939.9

申请日：2012-10-10

Applicant: Forward Pharma A/S

Inventor： Terwey, Theis ,  Rupp, Ronald ,  Andersen, Peder M.

IPC: A61K31/215 ,  A61K31/275 ,  A61K9/00 ,  A61P29/00 ,  A61K31/137 ,  A61K31/47

CPC classification number: A61K31/225 ,  A61K9/209 ,  A61K9/28 ,  A61K31/137 ,  A61K31/215 ,  A61K31/275 ,  A61K31/277 ,  A61K31/47 ,  A61K31/4704 ,  A61K2300/00

Abstract: The present invention relates to a method of treating MS in a human patient in need of such treatment and comprises administering to said patient a combination therapy in a single oral dosage form (e.g. a tablet or capsule) of dimethylfumarate and one agent selected from teriflunomide (or its prodrug leflunomide), fingolimod and laquinimod. This combination is more effective than the single agents alone and/or has reduced side effects and better tolerability than the single agents alone and/or can be given in a reduced frequency. Moreover, the present invention is directed to a pharmaceutical composition suitable for the oral treatment of multiple sclerosis consisting of dimethylfumarate and one agent selected from teriflunomide, fingolimod and laquinimod as active ingredients and one or more pharmaceutically acceptable excipients.

Abstract translation: 本发明涉及在需要这种治疗的人类患者中治疗MS的方法，并且包括给予所述患者在单一口服剂型（例如片剂或胶囊）中的富马酸二甲酯和选自特立氟胺（ 或其前药来氟米特），芬戈莫德和拉喹莫德。 这种组合比单独使用单一药剂更有效，和/或比单独使用单一药剂和/或可以降低频率给药的副作用和耐受性更好。 此外，本发明涉及适于口服治疗多发性硬化症的药物组合物，所述多发性硬化症由富马酸二甲酯和选自特立氟胺，芬戈莫德和拉喹莫德的一种药剂作为活性成分以及一种或多种药学上可接受的赋形剂组成。

公开(公告)号：EP2692343A1

公开(公告)日：2014-02-05

申请号：EP12179232.9

申请日：2012-08-03

Applicant: Forward Pharma A/S

Inventor： Terwey, Dr. med. Theis ,  Rupp, Dr. Ronald ,  Andersen, MD, Peder M.

IPC: A61K31/215 ,  A61K31/275 ,  A61K9/00 ,  A61P29/00

CPC classification number: A61K31/225 ,  A61K9/209 ,  A61K9/28 ,  A61K31/137 ,  A61K31/215 ,  A61K31/275 ,  A61K31/277 ,  A61K31/47 ,  A61K31/4704 ,  A61K2300/00

Abstract: The present invention relates to a method of treating MS in a human patient in need of such treatment and comprises administering to said patient a combination therapy in a single oral dosage form (e.g. a tablet or capsule) of dimethylfumarate and teriflunomide (or its prodrug leflunomide) which is more effective than the single agents alone and/or has reduced side effects and better tolerability than the single agents alone and/or can be given in a reduced frequency. Moreover, the present invention is directed to a pharmaceutical composition suitable for the oral treatment of multiple sclerosis consisting of dimethylfumarate and teriflunomide as active ingredients and one or more pharmaceutically acceptable excipients.

Abstract translation: 本发明涉及在需要这种治疗的人类患者中治疗MS的方法，包括向所述患者施用联合治疗单一口服剂型（例如片剂或胶囊）的富马酸二甲酯和特立氟胺（或其前药来氟米特 ），其比单独的药剂更有效，和/或具有比单独的药剂更少的副作用和更好的耐受性和/或可以以降低的频率给予。 此外，本发明涉及一种适用于口服治疗多发性硬化症的药物组合物，其由富马酸二甲酯和特里氟铵作为活性成分和一种或多种药学上可接受的赋形剂组成。

公开(公告)号：EP2379063B1

公开(公告)日：2013-03-13

申请号：EP10700730.4

申请日：2010-01-08

Applicant: Forward Pharma A/S

Inventor： NILSSON, Henrik ,  RUPP, Roland

IPC: A61K9/28 ,  A61K31/215 ,  A61P17/06 ,  A61K9/20 ,  A61K31/225

CPC classification number: A61K9/28 ,  A61K9/2054 ,  A61K9/2846 ,  A61K9/2866 ,  A61K9/2886 ,  A61K31/215 ,  A61K31/225