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Medicines360 and Allergan Present Four-Year Multi-Center Pivotal Trial Data of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg at the 2017 ACOG Meeting

Published 8 May 2017

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Allergan plc (NYSE:AGN), a leading global pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, presented four-year data from their ongoing multi-center U.S.-based pivotal trial of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg at the American College of Obstetricians and Gynecologists (ACOG) annual clinical and scientific meeting. LILETTA is an intrauterine system (IUS), approved for the prevention of pregnancy for up to three years. Women from the U.S. aged 16–45 years were enrolled and followed in the clinical trial. Women aged 36–45 years received the IUS for safety evaluation only. The abstract presents four-year pregnancy rates (by Pearl Index and life-table analysis) and safety outcomes from the ongoing study. Of note, the presentation on contraception/family planning has been awarded a blue ribbon by the ACOG Committee on Scientific Program.

IUD placement occurred in 1,568 (98%) women aged 16–35 years and 146 (97%) women aged 36–45 years, including 1,011 (57.7%) nulliparous (women who have not given birth) and 438 (25.1%) obese women. The Pearl Index in the first year among women 16–35 years at enrollment was 0.15 (95% CI 0.02–0.55). The cumulative life-table pregnancy rate at 4 years was 0.78 (95% CI: 0.37, 1.60).

Perforation following IUS placement occurred in two (0.1%) women; both were diagnosed within the first year. Expulsion was reported in 63 (3.7%) participants, and most (50 [80.6%]) occurred during the first year of use. Pelvic infection was diagnosed in 12 (0.7%) women. Only 38 (2.2%) women discontinued due to bleeding complaints over 4 years.

"We are encouraged by this information presented today at ACOG, which represents the data from our ongoing clinical trial used in our recent submission to the FDA requesting approval of LILETTA for up to four years of use,” said CEO of Medicines360, Dr. Jessica Grossman.

The poster presentation “Four-year efficacy and safety of the LILETTA® levonorgestrel intrauterine system” was presented by Dr. Mitchell D. Creinin, M.D., Professor, Director of Family Planning at ‎University of California, Davis on Saturday, May 6.

ABOUT LILETTA®

Indication

LILETTA® is a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to 3 years. The system should be replaced after 3 years if continued use is desired.

Important Safety Information

(scroll to see additional Important Safety Information and full Prescribing Information link)

Who is not appropriate for LILETTA®

Use of LILETTA® is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUS; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of LILETTA®.

Clinical considerations for use and removal of LILETTA®

Use LILETTA® with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing the intrauterine system if these or the following arise during use: uterine or cervical malignancy or jaundice. Because irregular bleeding/spotting is common during the first months of LILETTA® use, exclude endometrial pathology (polyps or cancer) prior to the insertion of LILETTA® in women with persistent or uncharacteristic bleeding. If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. If LILETTA® is displaced (eg, expelled or perforated the uterus), remove it.

Pregnancy related risks with LILETTA®

If pregnancy should occur with LILETTA® in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with LILETTA®. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.

Educate her about PID

Insertion of LILETTA® is contraindicated in the presence of known or suspected PID or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. About 1/3 of women diagnosed with PID developed the infection within a week of LILETTA® insertion, while the remainder were diagnosed more than six months after insertion. Counsel women who receive LILETTA® to notify a healthcare provider if they have complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, or genital lesions or sores. PID is often associated with sexually transmitted infections (STIs); LILETTA® does not protect against STIs, including HIV. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death.

Expect changes in bleeding patterns with LILETTA®

Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.

If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUSs like LILETTA® are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of LILETTA® is essential in order to minimize serious infections such as GAS.

Perforation (total or partial, including penetration/embedment of LILETTA® in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy. If perforation occurs, locate and remove LILETTA®. Surgery may be required. Delayed detection or removal of LILETTA® in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.

Partial or complete expulsion of LILETTA® may occur, resulting in the loss of contraceptive protection.

Delay LILETTA® insertion a minimum of 6 weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled LILETTA®. If expulsion has occurred, a new LILETTA® may be inserted within 7 days after the onset of a menstrual period after pregnancy has been ruled out.

Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent ovarian cysts.

In the clinical trial of LILETTA® the most common adverse reactions (≥5% users) were vaginal infections (13.6%), vulvovaginal infections (13.3%), acne (12.3%), headache or migraine (9.8%), nausea or vomiting (7.9%), dyspareunia (7.0%), abdominal pain or discomfort (6.8%), breast tenderness or pain (6.7%), pelvic discomfort or pain (6.1%), depression or depressed mood (5.4%), and mood changes (5.2%).

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of LILETTA® and then yearly or more often if clinically indicated.

For full prescribing information, visit www.LILETTA.com

ABOUT ALLERGAN WOMEN’S HEALTHCARE

Allergan is a leader in women’s health care that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women’s healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women’s HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.

ABOUT ALLERGAN

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

ABOUT MEDICINES360

Medicines360, located in San Francisco, California, is a nonprofit global women's health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage, or geographic location. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.