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Pharmaxis recibe la aprobación para la comercialización de Bronchitol en la UE


News provided by

Pharmaxis

Apr 27, 2012, 03:00 ET

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ELTVILLE, Alemania, April 27, 2012 /PRNewswire/ --

La compañía farmacéutica Pharmaxis (ASX: PXS) se complace en anunciar que ha recibido la Autorización de la Comisión Europea para la comercialización de Bronchitol. Esta aprobación permite la aplicación en 29 países europeos de un nuevo tratamiento para la fibrosis quística, en pacientes de 18 años en adelante  como una terapia coadyuvante a la atención médica estándar.

Dr. Alan Robertson, director general de Pharmaxis, ha señalado: "Este es un hito muy significativo que supone que los pacientes que viven con fibrosis quística in Europa, podrán recibir los beneficios clínicos probados de Bronchitol".

 Los pacientes con fibrosis quística en Alemania y en Reino Unido, donde  hay menos requisitos para aprobar la fijación de precios y el reembolso antes de su lanzamiento, serán los primeros en beneficiarse de Bronchitol. Estos dos países representan el 40% del valor del mercado europeo.

Bronchitol ha sido creado para ayudar a limpiar las vías respiratorias de pacientes con la enfermedad genética más común del mundo y que reduce la expectativa de vida, la fibrosis quística: En dos extensos ensayos clínicos en Fase 3, Bronchitol mejoró la evacuación de mucosidad, la función pulmonar y redujo episodios infecciosos en comparación con el grupo de control, donde los pacientes fueron tratados durante 6 meses.

El Dr. Robertson ha declarado: "Hemos dado un impulso considerable a Bronchitol en los últimos meses con los equipos de ventas de Alemania y Reino Unido específicamente reclutados y entrenados para ello.

"Pharmaxis ha conseguido la aprobación de tres medicamentos en los mayores mercados farmacéuticos del mundo; Aridol para la prueba de la función pulmonar en Europa y EEUU y ahora Bronchitol en Europa y Australia. Esto aumenta el prestigio, no sólo de la compañía, también de los investigadores y pacientes de todo el mundo que han participado en nuestros programas clínicos" concluye el Dr. Robertson.

Sobre Pharmaxis

Pharmaxis (ACN 082 811 630) es una empresa farmacéutica especializada que participa en la investigación, el desarrollo y la comercialización de productos terapéuticos para enfermedades respiratorias crónicas. Su producto, Aridol®, para la valoración de asma, se ha lanzado a muchos de los mercados más importantes. Su proyecto de desarrollo de productos incluye: Bronchitol para fibrosis quística, bronquiectasia y enfermedades pulmonares obstructivas crónicas (COPD), PXS25 para el tratamiento de fibrosis pulmonar y ASM8 y PXS4159 para el asma. Pharmaxis se encuentra en el listado del Mercado de Valores de Australia (con el símbolo PXS). La empresa tiene su sede en Sydney, en sus instalaciones de fabricación aprobadas por la TGA.  Para más información sobre Pharmaxis, visite http://www.pharmaxis.com.au o póngase en contacto con Investor Relations en el teléfono +61 2 9454 7200.

Sobre Bronchitol

El Bronchitol ha sido desarrollado con el fin de evacuar la mucosidad (una fuente principal de infecciones pulmonares), mejorar la función pulmonar y reducir las exacerbaciones en pacientes con fibrosis quística.

El Bronchitol es una fórmula patentada de manitol que se administra como polvo seco en un inhalador manual adecuado. El Bronchitol hidrata los pulmones, ayuda a restablecer la limpieza pulmonar normal y permite a los pacientes eliminar la mucosidad de forma más efectiva. Los estudios clínicos han demostrado que el Bronchitol es seguro, efectivo y que se tolera bien en el tratamiento para pacientes con fibrosis quística.

Sobre la fibrosis quística

En una persona sana, existe un flujo constante de moco sobre las superficies de los conductos respiratorios de los pulmones, eliminándose los restos y las bacterias. En la FQ, una enfermedad heredada, un gen defectuoso interrumpe el transporte de iones a través de la membrana epitelial dentro de las células.  En los pulmones, esto conduce a una disminución del líquido superficial de las vías respiratorias que normalmente baña los cilios, lo cual deriva en una reducción de la evacuación mucociliar. El resultado es la obtención de un moco espeso y pegajoso que obstruye los pulmones, restringiendo gravemente el proceso natural de evacuación de las vías respiratorias. Asimismo, incrementa las posibilidades de que las bacterias queden atrapadas y que exista inflamación, por lo que se crea un entorno pulmonar perjudicial que conduce a infecciones pulmonares muy graves.

Forward-Looking Statements

Forward-looking statements in this media release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the potential for Aridol and/or Bronchitol. All forward-looking statements included in this media release are based upon information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement as a result of new information, future events or otherwise. We cannot guarantee that any product candidate will receive regulatory approval or that we will seek any such approval.

CONTACTOS DE PRENSA
ACH
Elena Gallego
Teléfono: +34-91-745-48-00
Email: [email protected]

SOURCE Pharmaxis

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