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news.Merck has filed ridaforolimus marketing authorization application (MAA) with the European Medicines Agency (EMA).
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Ridaforolimus is an investigational mTOR inhibitor being developed by Merck that has completed a Phase 3 clinical trial in patients with soft-tissue and bone sarcomas and is being studied in multiple cancer indications.
Earlier in July 2007, Merck and ARIAD Pharmaceuticals entered into a collaboration to jointly develop ridaforolimus for multiple potential cancer indications.
In May 2010, the companies have made changes in the agreement, under which ARIAD granted Merck an exclusive license to develop, manfacture and commercialize ridaforolimus in oncology.
Subsequently, Merck has assumed responsibility for ridaforolimus activities, including clinical trials and regulatory filings.
The acceptance of MAA by EMA will allow ARIAD to receive $25m milestone payment from Merck.
Additionally, if ridaforolimus is approved in the US Merck will pay a sum of $25m to ARIAD and approval to sell ridaforolimus, including pricing approval, in the European Union will secure a $10m milestone payment.
ARIAD chairman and CEO Harvey Berger said they look forward to the submission of additional filings on ridaforolimus and to the review of ridaforolimus as a potential new treatment option for patients with metastatic soft-tissue and bone sarcomas.