Abbott, www.abbott.com – one of the undisputed global health care leaders with proficiencies in pharmaceuticals, nutritionals, diagnostics and devices, and Neurocrine Biosciences, Inc. (NBIX), www.neurocrine.com – the biopharma developer focused on endocrine and neurological disease/disorders, announced entry into a collaborative agreement for developing and bringing the new endometriosis-related pain treatment, Elagolix, to full commercialization.
Elagolix is a gonadotropin-releasing hormone (GnRH) antagonist which inhibits receptors in the pituitary gland, giving it a unique functionality as an estrogen delimiter which is able to relieve symptoms without the typical adverse side effects.
Elagolix is a first-in-class oral 8 preparation which has shown pain reduction effectiveness in Phase II endometriosis trials (recently completed Phase IIb), and which has been studied in 18 clinical trials to date comprising more than 1,000 subjects.
Elagolix also shows promise for addressing the strikingly problematic benign tumors called uterine fibroids which can form on the wall of the uterus and – depending on their number and density – lead to a variety of painful and even serious conditions like miscarriages and infertility.
Senior VP of Pharmaceuticals, Research and Development at ABT, John Leonard, M.D. pointed to the abundant preclinical and clinical data as clear indicators that Elagolix represents an “important advance” for endometriosis (100M women worldwide according to The World Endometriosis Research Foundation) and uterine fibroid patients.
In the US alone, direct and indirect costs related to endometriosis are projected at over $20B a year, and Dr. Leonard notes the prevalence of the condition and massive demand for new treatments, pointing to this agreement as a huge boon for ABT’s late-stage pipeline, with great potential for more compounds in earlier stage development.
The agreement indicates that ABT will obtain worldwide rights for development and commercialization of Elagolix (and all of the next-gen GnRH antagonists develop for men and women) in exchange for $75M upfront and the funding of development.
The agreement further stipulates that NBIX is eligible for commercial, development and regulatory milestone bonus payments of approximately $500M from ABT, royalties on future product sales, and funding for specific internal expenses associated with collaboration.
President and CEO of NBIX, Kevin Gorman, was clearly pleased at having a sector powerhouse like ABT on-board for the big push to get this miraculous and much-sought-after new drug to market, indicating to shareholders that satisfaction of the overwhelming market demand with a successful product will directly translate into returns.