Abbott Laboratories (ABT) has been working with Neurocrine Biosciences, Inc. (NBIX) on a treatment for endometriosis in women. The two companies have been working together for about two years now on clinical studies with a drug called elagonix to treat endometriosis. It is important to take a closer look at this story if you are a long-term investor or interested in long-term investing in Abbott Laboratories.
Elagonix is a significant addition to the company's drug arsenal, considering the annual direct and indirect costs of endometriosis are estimated to exceed $20 billion in the United States alone. It could be an important catalyst for Abbott's revenue stream.
Elagonix is a GnRH antagonist. A GnRH antagonist 'antagonizes' two hormones involved in triggering the menstrual cycle in women - the LH hormone and the FHS hormone. This prevention of menstruation slows or stops the growth of endometriosis, sending the body into a "menopausal" state. And this condition is no fun for women.
Endometriosis is a condition when tissue that normally grows inside the uterus grows outside, usually on organs or abdominal walls - in places it is not suppose to grow. And it can be very painful. In a normal menstrual cycle, a woman's endometrial tissue builds up inside her uterus, breaks down into blood & tissue and is cleaned out in her menstrual flow.
The areas of growth outside the uterus also breakdown into blood and tissue like those inside, but cannot leave the body through the woman's cycle. This causes the body to create chemicals that irritate the tissue around the exterior growth. This is why women go through so much pain. The World Endometriosis Research Foundation estimates that there are approximately 100 million women worldwide who suffer from endometriosis.
The studies on elagnoix are very promising. Neurocrine Biosciences started the studies in 2006. Phase I Studies demonstrated that elagolix was safe and well tolerated. The reduction in estradiol (a sex hormone) has been correlated with a reduction in pain and other symptoms of endometriosis and is a useful biomarker for safety and efficacy. This was a start, and then they went into Phase II.
Two separate exploratory three-month Phase IIa trials took place and the efficiency of these studies was assessed by the Composite Pelvic Sign and Symptoms Score (CPSSS), this measures certain aspects of distress that women go through; such as dysmenorrhea, non-menstrual pelvic pain, dyspareunia, pelvic tenderness and induration (all elements of endometriosis pain).
The purpose of Phase IIb was two fold. First and foremost to assess the impact of six months of treatment of elagolix on bone mineral density at the conclusion of treatment and at six and 12 months post treatment. This study also assessed, as secondary endpoints, the impact of treatment on endometriosis symptoms as measured by CPSSS. Elagolix met the primary endpoint by having minimal impact on bone mineral density at the conclusion of treatment and also showed a statistical and clinically meaningful reduction in endometriosis symptoms as measured by CPSSS with an 86% responder rate in the 150mg once daily elagolix arm of the study.
Now, with such good results, Neurocrine and Abbott are working together on the Phase 3 trial which will last 24 weeks. It will be the most extensive yet; multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate-to-severe endometriosis-associated pain.
It was in June of 2010 that both decided to collaborate worldwide to develop and commercialize elagolix and all next-generation GnRH antagonists for women. Now Abbott Laboratories has primary responsibility for all regulatory interactions with the FDA. When this hits the market there is $20 billion waiting to flow into Abbott's coffers. This will play an important role in the company's revenue stream for the future. It is worth following if you are interested in investing in the stock, long term.