Isis Pharmaceuticals, Inc. (ISIS) earned a $1 million milestone payment from GlaxoSmithKline (GSK) pertaining to the advancement of ISIS-TTR in a randomized, double-blind, placebo-controlled phase II/III study in patients suffering from familial amyloid polyneuropathy (FAP). This study evaluates the effects of ISIS-TTR on neurological dysfunction and the quality of life of the patients. Results from this study will support the filing of a marketing approval application of ISIS-TTR for the above indication.
We remind investors that Isis Pharma had inked a deal with Glaxo in Mar 2010 for the development of up to six programs. Currently, the companies are working on five active programs, which include ISIS-TTR.
According to the deal, Isis Pharma will receive total milestone payments of $50 million from Glaxo for the development of ISIS-TTR. The latest payment of $1 million marks the fourth installment. To date, Isis Pharma has received $26 million, including upfront and milestone payments.
Glaxo has an option to exclusively license ISIS-TTR. Isis Pharma will receive license and regulatory fees, sales milestone payments and double-digit royalties on ISIS-TTR net sales, if Glaxo exercises this option.
Meanwhile, Isis Pharma and Glaxo are conducting an open-label extension study on ISIS-TTR in FAP patients who have completed dosing in the phase II/III study.
We note that Isis Pharma has partnership agreements with leading pharmaceuticals companies like Biogen Idec (BIIB) and Roche (RHHBY), among others. Earlier this month, Isis Pharma earned a milestone payment of $14 million from Biogen related to the initiation of a phase I study on ISIS-DMPK for the treatment of myotonic dystrophy type I.
Isis Pharma carries a Zacks Rank #3 (Hold). Biogen holds a Zacks Rank #1 (Strong Buy).
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