Isis Pharmaceuticals, Inc.
ISIS 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].
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