AbbVie touts promising PhIII data for Orilissa as execs line up their second pitch and rivals lay in wait

Researchers for AbbVie have detailed their data from a pair of Phase III uterine fibroid studies for Orilissa which they expect will push them to their second big OK for a drug widely viewed as a blockbuster-in-waiting.

Already approved for endometriosis, their drug at 300 mg twice daily easily outpaced a placebo in treating uterine fibroids, with a 68.5% and a 76.2% clinical response on the primary endpoint for reduced heavy menstrual bleeding. The placebo arms hit 8.7% and 10.1% respectively, offering a sharp and satisfying contrast for the AbbVie drug.

Roughly half of the women in the studies achieved an absence of bleeding or spotting in the last month of the 6-month trial. The drug was in-licensed from Neurocrine, which remains a close partner to AbbVie.

Jami Rubin, Goldman Sachs

AbbVie had already heralded its success for the study, and they are likely to get a new round of endorsements from analysts who look for this drug to break the $1 billion mark on peak sales. Jami Rubin, the prominent Goldman analyst, has offered her thumbs up for a success story with more than $2 billion in annual sales by 2025 — matching management’s bullish take.

But some analysts believe the upside may be limited at this stage. Marc Goodman at Leerink noted:

Orilissa (Elagolix) should also be a significant women’s health product for (Neurocrine’s) partner AbbVie (ABBV, MP), but consensus sales expectations are quite high for this as well and potential competition is under appreciated.

Company execs say they’ll make their pitch to regulators in the middle of next year.

Allergan had high hopes of beating AbbVie to the market with their rival drug, ulipristal acetate. But evidence of liver damage in patients taking the drug in Europe scuttled their initial pitch, forcing researchers back to the drawing board. Myovant $MYOV, one of the biotechs launched by Vivek Ramaswamy, is pursuing work on their own drug — relugolix — after doing a partnership with Takeda. But it will have to differentiate itself from AbbVie’s drug.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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