PharmaMar ha Anunciado Hoy un Acuerdo de Licencia con la Farmacéutica Specialised Therapeutics Australia Pty, Ltd (STA) para Comercializar APLIDIN® en Australia y Nueva Zelanda. Es el Tercer Acuerdo que se Alcanza con Aplidin .

P.J.: Zeltia encara ya sus últimos días como tal ... y cada vez es más el Protagonismo de PharmaMar que a dos meses para absober a Zeltia y empezar a cotizar como tal ha alcanzado hoy un nuevo acuerdo de Licencia para Aplidin que abarca Australia y Nueva Zelanda ... Acuerdo que hay que Sumar a loa otros dos acuerdos alcanzados recientemente ... uno con Chugai ( Roche ) que abarca : Francia, Alemania, Reino Unido, Benelux, Irlanda y Austria) . ... Y otro Alcanzado con TTY Biopharm para su uso comercial en Taiwan. ... Según los términos de los acuerdos alcanzados , PharmaMar recibirá un pago por adelantado por la firma de cada acuerdo, asi como pagos recurrentes por ventas, y remuneraciones adicionales por los hitos de ventas y regulatorios alcanzados por APLIDIN® (plitidepsina). PharmaMar conservará los derechos de producción en exclusiva y sera la encargada de suministrar el producto .

Aplidin esta previsto tener los resultados finales de la Fase III este mismo año y de ser los esperados se iniciaría el proceso de elaboración del Dossier para ser presentado el Farmaco a las Autoridades para que estas den su OK a la Comercialización si asi lo ven acertado .

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PharmaMar Announces License Agreement with Specialised Therapeutics Australia Pty for APLIDIN® (plitidepsin) in oncology .

Madrid, Spain. August 20, 2015 –

PharmaMar has entered into an exclusive license and commercialization agreement with the pharmaceutical company Specialised Therapeutics Australia Pty (STA) to market and distribute the drug candidate APLIDIN® (plitidepsin) in Australia and New Zealand. Under the terms of the agreement, PharmaMar will receive an upfront payment, royalties as well as additional remunerations for regulatory and sales milestones achieved by APLIDIN® (plitidepsin). PharmaMar will retain exclusive production rights and will supply the finished product to STA for commercial use in Australia and New Zealand.

APLIDIN® (plitidepsin) is PharmaMar´s second anticancer drug candidate obtained from a marine organism and is currently under development for the treatment of multiple myeloma and a type of T cell lymphoma. The company announced in June that patient recruitment of the international pivotal Phase III trial (ADMYRE) for APLIDIN® (plitidepsin) in refractory/relapsed multiple myeloma was successfully completedi.
“Our commitment to bringing innovative therapies to all patients continues, and this collaboration with a strong pharmaceutical group in Australia and New Zealand is crucial for the role of the anticancer drug plitidepsin in these two important territories.” said José María Fdez. Sousa-Faro, Chairman of PharmaMar.
Specialised Therapeutics Australia Chief Executive Officer Mr. Carlo Montagner: “Multiple myeloma remains relatively rare, but it is an insidious disease with one of the lowest survival rates in oncology.” he said.
“There is a desperate need for new therapies and all data to date suggests APLIDIN® could become a first in class, novel drug to potentially improve therapeutic tools for multiple myeloma patients.”

“This drug is a welcome addition to STA’s expanding oncology portfolio and we look forward to making this treatment option available to patients in Australia and New Zealand, pending the release of pivotal Phase 3 data confirming its efficacy.”
“We applaud PharmaMar’s commitment in developing this important therapy and are delighted to collaborate with a partner of this calibre.”

Yondelis para el Tratamiento de Sarcomas Podría Aumentar y Mejorar su Respuesta Terapeutica ... RG7112, a Small-Molecule Inhibitor of MDM2, Enhances Trabectedin Response in Soft Tissue Sarcomas.

Published online: 14 Aug 2015 .

Obrador-Hevia A1, Martinez-Font E, Felipe-Abrio I, Calabuig-Fariñas S, Serra-Sitjar M, López-Guerrero JA, Ramos R, Alemany R, Martín-Broto J. .

Author information :

Group of Advanced Therapies and Biomarkers in Clinical Oncology, Institut d'Investigació Sanitària de Palma (IdISPa) , Palma de Mallorca , Spain.

Abstract :

MDM2 is a critical negative regulator of the p53 tumor suppressor protein. Selected sarcoma subtypes are being treated with Trabectedin in second line, which promotes DNA damage and p53-dependent apoptosis. The aim of this study was to evaluate the improvement of Trabectedin response with MDM2 inhibitors in soft tissue sarcomas. The antitumor effects of Trabectedin, Nutlin-3A and RG7112 as single agents or in combination were examined in vitro.

RG7112 significantly synergized with Trabectedin in MDM2-amplified liposarcoma cells, representing a promising new therapeutic strategy for the treatment of sarcomas with MDM2 amplification.