Ariad Opts-in To Co-Promote mTOR With Merck
This article was originally published in The Pink Sheet Daily
The biotech takes advantage of the Big Pharma's financial wherewithal and regulatory/market expertise to build out its own commercial infrastructure.
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FDA’s Oncologic Drugs Advisory Committee will be asked to consider a two-week median progression-free survival benefit with Merck/Ariad’s Taltorvic in the maintenance setting, and a three-month PFS advantage with GSK’s Votrient in second-line treatment.
FDA Panel Review Of Merck/Ariad’s Sarcoma Drug Could Hinge On Clinical Significance Of Progression-Free Survival Benefit
The Oncologic Drugs Advisory Committee will review two drugs for sarcoma indications on March 20: Merck/Ariad’s Taltorvic (ridaforolimus) and GlaxoSmithKline’s Votrient (pazopanib). With a three-week median PFS advantage in its pivotal trial, ridaforolimus could face the same questions about clinically significant benefit that led to revocation of Avastin’s metastatic breast cancer claim.
With positive signs for its stable of cancer drugs, including an imminent filing for the sarcoma candidate ridaforolimus, Ariad Pharmaceuticals Inc. is nearing the turning point from a development to a commercial company.