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04 octubre 2017
Aplidin Ha Sido Presentada en Suiza para su Posible Aprobación para Tratar Myeloma Múltiple .
Pharma Mar : PharmaMar submits the Marketing Authorisation Application for Aplidin® in Switzerland .
*.- Pharma Mar S.A. submitted the Marketing Authorisation Application in the European Union at the end of 2016 .
*.- The regulatory process for oncological products in Switzerland is independent from the European Medicines Agency (EMEA) .
Madrid, October 4th, 2017.
PharmaMar (PHM:MSE) announces submission of the Marketing Authorisation Application to the Swiss Agency for Therapeutic Products (Swissmedic) for Aplidin® for the treatment of patients with multiple myeloma.
The regulatory process for an oncological drug in Switzerland is independent from that of the European Medicines Agency´s process (EMEA), to which PharmaMar submitted the corresponding application at the end of 2016.
Aplidin® was designated orphan drug status by Swissmedic, the European Commission and also the Food and Drug Administration (FDA). In the European Union, this status is granted for the compounds that are investigated for the treatment of illnesses that affect 5 per 10,000 inhabitants or less. This gives the sponsor a series of incentives, among which are included the possibility of a priority evaluation by Swissmedic, the regulatory authority in Switzerland.
The submission of this application represents a milestone for PharmaMar. "We have obtained positive results with this molecule in the pivotal phase III study and we believe that Aplidin® could be a novel therapeutic alternative for patients with multiple myeloma that live in Switzerland", says Luis Mora, Managing Director at the Oncology Business Unit at PharmaMar.
*.- Pharma Mar S.A. submitted the Marketing Authorisation Application in the European Union at the end of 2016 .*.- The regulatory process for oncological products in Switzerland is independent from the European Medicines Agency (EMEA) .
Madrid, October 4th, 2017.
The regulatory process for an oncological drug in Switzerland is independent from that of the European Medicines Agency´s process (EMEA), to which PharmaMar submitted the corresponding application at the end of 2016.
Aplidin® was designated orphan drug status by Swissmedic, the European Commission and also the Food and Drug Administration (FDA). In the European Union, this status is granted for the compounds that are investigated for the treatment of illnesses that affect 5 per 10,000 inhabitants or less. This gives the sponsor a series of incentives, among which are included the possibility of a priority evaluation by Swissmedic, the regulatory authority in Switzerland.
The submission of this application represents a milestone for PharmaMar. "We have obtained positive results with this molecule in the pivotal phase III study and we believe that Aplidin® could be a novel therapeutic alternative for patients with multiple myeloma that live in Switzerland", says Luis Mora, Managing Director at the Oncology Business Unit at PharmaMar.
PharmaMar will participate at the 17th European Large & MidCap Event to be held in Paris .
PharmaMar estará presente en la 17ª edición de la European Large &MidCap event que se celebra en Paris .
*.-On October 4th and 5th, PharmaMar will meet with European investors to increase awareness of the Company and to explain in detail present and future projects.
*.-This 17th annual event will host 400 international investors with 140 listed companies .
*.-On October 4th and 5th, PharmaMar will meet with European investors to increase awareness of the Company and to explain in detail present and future projects.
*.-This 17th annual event will host 400 international investors with 140 listed companies .
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