AbbVie investigators delivered a fresh set of promising results for a key late-stage drug in the pipeline. In the first of two Phase III studies, the company reports that both doses of elagolix scored statistically significant results for chronic and painful cases of endometriosis among pre-menopausal women.
In a top-line assessment, AbbVie ($ABBV), which in-licensed the drug from Neurocrine Biosciences ($NBIX), said that the study hit its co-primary endpoints for "reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea), associated with endometriosis, at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale."
That's particularly good news for Neurocrine, which inked a $575 million licensing deal with Abbott ($ABT) (now AbbVie) way back in 2010. AbbVie launched a second Phase III study in late 2013. The followup study is designed to confirm the results of the first big trial, which enrolled 872 patients aged 18 to 49.
Neurocrine shares jumped 21% in morning trading on Thursday.
A few analysts, led by the bullish Deutsche Bank analyst Robyn Karnauskas, have pegged peak sales at a potential $1.2 billion-plus for this drug, which would make it a valuable addition for AbbVie as it positions itself ahead of biosimilar competition for the top-selling Humira. Just days ago AbbVie won an FDA approval for its hep C cocktail and is now looking to follow that up with more blockbusters in the making.
The second Phase III study of this drug--which inhibits gonadotropin releasing hormone (GnRH) receptors in the pituitary gland and is designed to reduce circulating sex hormone levels--is expected to wrap up before the end of this year.
"Endometriosis is a condition in which the tissue that normally lines the inside of a woman's uterus grows outside the uterus, and is often associated with severe, and at times, debilitating pain," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. "The positive results from this trial represent a significant milestone in the development of elagolix as a potential new treatment option for patients suffering from endometriosis."
- here's the release