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Biotech / Medical : Biogen
BIIB 224.69+1.9%Jan 24 4:00 PM EST

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From: Sr K8/1/2016 9:22:07 AM
   of 1683

Ionis Pharma (IONS 36.48, +7.29): +25.0% after Biogen (BIIB 302.00, +12.07) paid the company a $75 million licensing fee following positive Phase-3 trial results of nusinersen

The analysis found that infants receiving nusinersen experienced a statistically significant improvement in the achievement of motor milestones compared to those who did not receive treatment.

Nusinersen demonstrated an acceptable safety profile in the trial.

As a result of these findings,

Biogen has exercised its option to develop and commercialize nusinersen globally and paid Ionis a $75 million license fee.Biogen will initiate regulatory filings globally in the coming months.

Based on the results of the pre-specified interim analysis, the ENDEAR study will be stopped and participants will be able to transition into the SHINE open-label study in which all patients receive nusinersen.

  • Data from the other endpoints of ENDEAR will be analyzed when the full data set is available.

  • Biogen is now responsible for all nusinersen development, regulatory and commercialization activities and costs. Ionis will complete the Phase 3 studies and work with Biogen on regulatory filings.

    The two cos will also work together to transition the clinical programs that Ionis is conducting to Biogen.

    Ionis is eligible to receive tiered royalties on any potential sales of nusineren up to a percentage in the mid-teens, in addition to up to $150 million in milestone payments based on regulatory approvals.

    Cos will host a live webcast to discuss the results of the Phase 3 ENDEAR interim results for nusinersen today, August 1, 2016, from 9:00 to 9:30 a.m. EDT.
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