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Isis Announces That ISIS-TTR Rx Was Granted Fast Track Designation For The Treatment Of Patients With FAP
Date:12/13/2012

CARLSBAD, Calif., Dec. 13, 2012 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that the United States 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 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-TTRRx to support a registration-directed Phase 2/3 clinical study on ISIS-TTRRx, which is expected to start this month.

"We are pleased to have received orphan drug status and fast track designation for ISIS-TTRRx for patients with FAP.  ISIS-TTRRx is our most advanced drug from our severe and rare disease franchise and represents a significant near-term commercial opportunity for us," said B. Lynne Parshall, chief operating officer and chief financial officer at Isis.  "We look forward to continuing to move ISIS-TTRRx toward the market for patients who have very limited therapeutic options."

ISIS-TTRRx 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-TTRRx­.  In addition, Isis is eligible to receive regulatory and sales milestones and double-digit royalties on sales of ISIS-TTRRx.

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SOURCE Isis Pharmaceuticals, Inc.
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