Isis Pharma/GlaxoSmithKline's ISIS-TTR Rx gains US fast-track designation

14 December 2012

In what has been a busy newsflow few days for USA-based Isis Pharmaceutical (Nasdaq: ISIS), the company said yesterday that the US Food and Drug administration has granted ISIS-TTRRx fast track designation for the treatment of familial amyloid polyneuropathy (FAP).

ISIS-TTRRx is an antisense drug in development with UK pharma giant GlaxoSmithKline (LSE: GSK) for the treatment of transthyretin (TTR) amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. The original deal terms allow for a potential $1.5 billion for the US firm (The Pharma Letter April 1, 2010).

Isis and GSK recently amended the clinical development plan and financial terms relating to ISIS-TTRRx to support a registration-directed Phase II/III clinical study on ISIS-TTRRx, which is expected to start this month (TPL November 6).

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