AbbVie and Neurocrine Biosciences, Inc.’ Phase III ELARIS UF-1 clinical trial of elagolix for uterine fibroids hit its primary endpoint.

Uterine fibroids are abnormal growth in a woman’s pelvis, affecting up to 80 percent of women by age 50. The companies have two pivotal Phase III trials ongoing. The first showed at six months that elagolix, in combination with low-dose hormone therapy, cut heavy menstrual bleeding in 68.5 percent of women with fibroids compared to 8.7 percent in the placebo group as measured by the alkaline hematin method.

Evaluate Pharma estimated the drug has a potential $1.2 billion in peak sales, dubbing it one of the top 10 likely rollouts of the year.

“Current non-surgical treatments are limited and women suffering from uterine fibroids need more therapeutics options,” said Dawn Carlson, vice president of AbbVie’s general medicine development, in a statement. “The results from this study represent a significant advancement in the development of elagolix and demonstrate our continued commitment to address serious disease.”

This data is topline results from a six-month primary analysis. Women in the trial will continue in a post-treatment follow-up or a blinded six-month extension study.

John Carroll, with Endpoints News, writes, “AbbVie is already looking at a Q2 decision from the FDA on endometriosis, and the company looks ready to start hunting a follow-up approval once they gather data from the second Phase III study. AbbVie got this drug in a $575 million deal it struck in 2010 with Neurocrine, which stands to earn a royalty payout on an approval.”

Yesterday, AbbVie inked a collaboration deal with Cambridge, Massachusetts-based Voyager Therapeutics to focus on vectorized tau antibodies for Alzheimer’s disease. AbbVie is paying $69 million upfront and up to $155 million in preclinical and Phase I option payments. Voyager is also eligible to receive up to $895 million in development and regulatory milestones for each compound, and is eligible for tiered royalties on any commercial products that come out of the deal.

The antibodies are against tau protein. In Alzheimer’s patients, abnormal tau protein tangles appear toward the end of the disease and are correlated with progressive neurodegeneration and severity. Current limitations for the use of biologics infusions is that only a small amount of drug can pass the blood-brain barrier. The two companies will work to develop a possible one-time therapeutic that utilizes Voyager’s gene therapy platform that generates adeno-associated viral (AAV) vectors.

With the best-selling drug in the world, Humira, AbbVie continues to its strong growth. Keith Speights, writing for The Motley Fool, notes three more reasons to invest in the stock. First, the company’s dividend recently creased by 35 percent. Second, it also announced a $10 billion stock-repurchase program. And third, the company recently announced new data from a Phase II trial of upadacitinib for Crohn’s disease, which is a way forward for the company to fend off the inevitable—although still down the road—drop in Humira sales.

Speights notes, “The company has a great track record and its current drugs are performing very well. It has a pipeline loaded with potential winners and continues to reward shareholders through increased dividends and share buybacks. So is there any reason not to buy AbbVie stock? If your only priority is growth, you can probably find stocks that might generate higher growth than AbbVie. If you’re looking strictly for income, there are stocks with higher dividend yields. And if you’re a value investor, there are stocks that are even better bargains.”

On the other hand, AbbVie offers a strong combination of growth, income and value.



BioSpace source: