Isis Pharma Announces Fast Track Designation for ISIS-TTR Rx for Treatment of Patients with FAP

Isis Pharmaceuticals, Inc.

announced today that the United States Food and Drug administration has granted ISIS-TTR[Rx] fast track designation for the treatment of familial amyloid polyneuropathy (FAP).  ISIS-TTR[Rx ]is an antisense drug in development with GlaxoSmithKline (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.  Isis and GSK recently amended the clinical development plan and financial terms relating to ISIS-TTR[Rx ]to support a registration-directed Phase 2/3 clinical study on ISIS-TTR[Rx], which is expected to start this month. ISIS-TTR[Rx] is part of the Isis-GSK strategic alliance to develop RNA therapeutics for rare and infectious diseases.  Upon initiation of the Phase 2/3 study, Isis will receive a $7.5 million milestone payment and is eligible to earn an additional $50 million in pre-licensing milestone payments to support the Phase 2/3 study of ISIS-TTR[Rx.  ]In addition, Isis is eligible to receive regulatory and sales milestones and double-digit royalties on sales of ISIS-TTR[Rx].