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aced with a steep drop in sales from its only approved product, the Seattle biotech Omeros hatched a plan to make up for the shortfall: secure speedy approval for its lead pipeline drug to treat a rare but often-deadly complication of bone marrow transplants.

The drug, called OMS721, had a “clear path” to approval, CEO Greg Demopulos said May 10. In the days that followed, the company’s stock price rose 50 percent. But investors who believe Omeros can succeed aren’t considering all the risks. This plan has flaws.

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  • The correct studies to use to compare Soliris with OMS721 do not include Jodele et al because that study was in pediatric patients whereas OMS721’s results were in (typically older) adults, whose prognosis is far poorer. In the two studies of Soliris in adult HSCT-TMA patients 1-year survival for Soliris treated patients was around 33% with mOS of 21 weeks.

    Also note, that Alexion hasn’t disclosed plans to seek regulatory approval for this indication, probably because of the whole death by infection thing as they already have a black box warning for infections. TMA patients have had their immune systems destroyed and replaced with a graft, which needs time to… engraft and fully replenish the patients’ immune response. This happens more quickly in children, which is why Soliris causes fewer infections in that population. Regardless, does anyone actually believe Alexion will still be able to sell Soliris off label to HSCT-TMA patients with a black box warning after OMS721 is approved for the indication?

    Insurers will surely cover an off-label 500k drug with a black box warning for infections in a immunocompromised patient population when an approved drug for the indication exists, right?

    Studies:
    https://www.ncbi.nlm.nih.gov/pubmed/28860002

    https://www.ncbi.nlm.nih.gov/pubmed/25651309

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