GlaxoSmithKline amends accord with Isis Pharma; gets FDA panel backing for raxibacumab
USA-based Isis Pharmaceuticals (Nasdaq: ISIS) says it has agreed to amend the clinical development plan and financial terms relating to ISIS-TTRRx with UK pharma giant GlaxoSmithKline (LSE: GSK) to reflect the accelerated development plan for the drug.
ISIS-TTRRx is an antisense drug in development with GSK for the treatment of TTR amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerves and/or heart tissue, under an agreement that, according to the original deal, was worth a potential $1.5 billion to the US firm (The Pharma Letter April 1, 2010). The revised development plan anticipates initiation of a Phase II/III, registration-directed, clinical study later this year. ISIS-TTRRx is one of several promising drugs in Isis' pipeline that the firm expects will begin registration-directed studies within the next several years.
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