AbbVie Presents Pivotal Phase 3 Data on Investigational Treatment Elagolix and Research on the Economic Burden of Endometriosis at the 72nd American Society for Reproductive Medicine Scientific Congress

- New detailed results to be presented on primary and secondary efficacy and safety from two pivotal Phase 3 studies evaluating the use of Elagolix in endometriosis-associated pain

- Additional data will be presented on the economic burden of endometriosis and endometriosis-related surgery in women in the United States

News provided by

AbbVie

Oct 06, 2016, 08:00 ET

NORTH CHICAGO, Ill., Oct. 6, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that new data from two replicate Phase 3 studies evaluating the efficacy and safety of Elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, in premenopausal women with endometriosis, will be presented at the upcoming 72^nd American Society for Reproductive Medicine Scientific Congress & Expo (ASRM), October 15-19, in Salt Lake City. Additional data highlighting the economic and healthcare burden associated with endometriosis will also be presented.

"Endometriosis affects an estimated one in 10 women,¹ and physicians and their patients are seeking alternative options to help relieve symptoms of this disease," said Rob Scott, M.D., Vice President, Development and Chief Medical Officer, AbbVie. "The data highlight the efficacy and safety profile of Elagolix in the treatment of pain associated with endometriosis, and underscore AbbVie's efforts to help address the needs of women suffering from endometriosis."

AbbVie Posters:

Elagolix, An Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist, For The Management Of Endometriosis-Associated Pain: Safety And Efficacy Results From Two Double-Blind, Randomized, Placebo-Controlled Studies; Taylor H, et al.; Abstract #P440; Poster Session; Wednesday, October, 19, 2016; 7:00AM – 8:45AM MDT
Use Of Elagolix For The Management Of Endometriosis-Associated Pain: Secondary Efficacy Results From Two Randomized, Placebo-Controlled Studies : Surrey, et al.; Abstract #P434; Poster Session; Wednesday, October, 19, 2016; 7:00AM – 8:45AM MDT
The Effect Of Elagolix On Bone Mineral Density: Safety Results From Two Randomized, Placebo-Controlled Studies In Women With Endometriosis-Associated Pain; Archer et al.; Abstract #P455; Poster Session; Wednesday, October, 19, 2016; 7:00AM – 8:45AM MDT
Incremental Costs of Healthcare and Work Loss Attributed to Endometriosis in a Cohort of Commercially Insured Women; Soliman et al.; Abstract #P432; Poster Session; Wednesday, October, 19, 2016; 7:00AM – 8:45AM MDT
Incidence of Comorbidities Among Women with Endometriosis: A Retrospective Matched Cohort Study; Soliman et al.; Abstract # P457; Poster Session; Wednesday, October, 19, 2016; 7:00AM – 8:45AM MDT

AbbVie Oral Presentations

The Effect Of Elagolix On The Endometrium: Safety Results From Two Randomized, Placebo-Controlled Studies In Women With Endometriosis-Associated Pain; Diamond et al.; Abstract #O232; Oral Session; Wednesday, October, 19, 2016; 11:15AM – 12:45PM MDT
The Impact of Elagolix on Quality of Life in Women with Endometriosis-Associated Pain: Results From Two Randomized, Placebo-Controlled Studies Using the Endometriosis Health Profile Questionnaire; Taylor H et al.; Abstract #O229; Oral Session; Wednesday, October, 19, 2016; 11:15AM – 12:45PM MDT
Direct and Indirect Costs Associated with Endometriosis-Related Surgery Among Employed Women in the US; Soliman et al.; Abstract #O230; Oral Session; Wednesday, October, 19, 2016; 11:15AM – 12:45PM MDT

About Endometriosis
Endometriosis occurs when the cells that normally line the uterus begin to grow outside of the uterus, leading to chronic pelvic pain, pain with intercourse and heightened pain with menses.² These growths are called lesions and can occur on the ovaries, the fallopian tubes, or other areas near the uterus, such as the bowel or bladder.^3,4 There is no cure for endometriosis and the associated pain is currently managed with oral contraceptives, progestins, danazol, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists, many of which are not specifically indicated for the treatment of endometriosis. In more extensive cases, surgical interventions (e.g., laparotomy or laparoscopy) are often pursued, and may not be curative for all individuals.⁵

About Elagolix
Elagolix, a gonadotropin-releasing hormone (GnRH) antagonist, is an orally administered, short-acting molecule that blocks GnRH signaling by binding to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. To date, Elagolix has been studied in over 40 clinical trials totaling more than 3,000 subjects. Phase 3 trials of Elagolix for the management of uterine fibroids are ongoing.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.


¹ World Endometriosis Society: Facts About Endometriosis: http://endometriosisfoundation.org/Facts-about-endometriosis.pdf. Accessed October 10, 2016.
² Mayo Clinic. Diseases and Symptoms: Endometriosis Fact Sheet. http://www.mayoclinic.org/diseases-conditions/endometriosis/basics/symptoms/con-20013968. Accessed February 1, 2016.
³ MM, Silverberg K, Olive DL. Endometriosis and Adenomyosis. IN: Copeland LJ, Jarrell JF, eds. Textbook of Gynecology. 2nd ed. Philadelphia, PA: WB Saunders; 2000:687-722.
⁴ The American College of Obstetricians and Gynecologists. ACOG Education Pamphlet AP013: Endometriosis. Washington, DC: September 2008. ISSN 1074-8601.
⁵ Mayo Clinic. Diseases & Conditions: Endometriosis Fact Sheet. http://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/treatment/txc-20236449. Accessed February 1, 2016.