Siliq US Approval Expected To Make Little Dent In Valeant Debt Mountain
A Black Box warning on suicidal ideation and behavior, a REM program and a Medication Guide may hold back the sales growth of Valeant’s new psoriasis therapy in the US, Siliq, following its Feb. 15 approval, although the drug has been associated with high levels of total skin clearance, a finding that could differentiate it from competing products.
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The troubled firm has pushed back its greatest debt burden until 2020, but new products are unlikely to fill sales gap. Valeant says its GI unit is showing positive signs and that a restructuring of the derm commercial unit is nearing completion.
Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.
FDA notified the company the US review goal date for the psoriasis pill has been extended three months from Nov. 16 to Feb. 16.