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Isis Earns GSK Milestone

Advances Phase II/III study of ISIS-TTR in FAP

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By: Kristin Brooks

Managing Editor, Contract Pharma

Isis Pharmaceuticals, Inc. has earned a $15 million milestone payment from GSK related to advancing the Phase II/III study of ISIS-TTRRx in patients with familial amyloid polyneuropathy (FAP). 
 
ISIS-TTRRx is an antisense drug the companies are developing for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. To date, Isis has generated $60 million in upfront and milestone payments for advancing ISIS-TTRRx. If GSK exercises its option to exclusively license ISIS-TTRRx, Isis is eligible to receive a license fee, regulatory and sales milestones, and royalties on sales.
 
The study is designed to support an application for marketing approval of ISIS-TTRRx in patients with FAP, and will measure the effects of ISIS-TTRRx on neurological dysfunction and on quality-of-life. 
 
“We are very pleased with the progress we are making with ISIS-TTRRx, and plan to report data from the Phase II/III study in 2017. We have many patients who have completed the fifteen months of dosing and are now receiving ISIS-TTRRx in an open-label extension study,” said B. Lynne Parshall, chief operating officer at Isis Pharmaceuticals.

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