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Isis Initates Phase 2/3 Study Of ISIS-TTR Rx And Earns $7.5 Million Milestone Payment From GlaxoSmithKline
Date:2/19/2013

S-TTRRx on neurological dysfunction and on quality-of-life.  The United States Food and Drug administration granted ISIS-TTRRx fast track designation and orphan drug status for the treatment of FAP.

"The rapid development of ISIS-TTRRx from a research-stage program to a drug in late-stage clinical development in just over two years represents the strong commitment of both teams to bring this novel drug to patients who are in need of new therapeutic options," said B. Lynne Parshall , chief operating officer at Isis.  "The encouraging data from our Phase 1 study, in which our drug was well tolerated and produced significant reductions in TTR protein, supported the advancement of ISIS-TTRRx directly into this registration-directed Phase 2/3 study.  While we will continue to manage the clinical development of ISIS-TTRRx, we will benefit from GSK's late-stage clinical development, regulatory and commercial expertise."

ISIS-TTRRx is part of the Isis-GSK strategic alliance to develop RNA therapeutics for rare and infectious diseases.  For the 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 milestone payments and double-digit royalties on sales of ISIS-TTRRx.

ABOUT ISIS-TTRRx
Transthyretin amyloidosis is a genetic disease in which the patient inherits a mutant gene that produces a misfolded form of TTR, which progressively accumulates in tissues, impairing their function.  In patients with transthyretin amyloidosis, both the mutant and normal forms of TTR can build up as fibrils in tissues, including heart, peripheral nerves, and the gastrointestinal tract.&
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SOURCE Isis Pharmaceuticals, Inc.
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