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Allergan and Medicines360 Announce Donation of Intrauterine Devices (IUD) to the Centers for Disease Control (CDC) Foundation to Help Address Microcephaly Impact from Zika Virus in Puerto Rico

Published 31 May 2016

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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, today announced that they will donate 10,000 units of their hormonal IUD, LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg, to the U.S. Centers for Disease Control (CDC) Foundation. In addition, Allergan will donate over 40,000 one-month cycle packs of oral contraceptives. The contributions are in response to the outbreak of the Zika virus and are designed to help reduce unintended pregnancies in Puerto Rico, while the risk of the Zika virus is prevalent. Research has shown that pregnant women infected with the Zika virus are at risk of giving birth to infants born with microcephaly -- a birth defect caused by the exposure to the Zika virus where a baby's head is smaller than expected when compared to babies of the same sex and age. Babies with the condition often have smaller brains that might not develop properly.

Following this initial donation, Allergan will continue to partner with the CDC Foundation to assess the need for additional oral contraceptive supplies in this important Zika response.

"There is a clear and immediate need for effective, contraceptive options in Puerto Rico and communities throughout the world to give women the option to reduce the risk of unintended pregnancies while the risk of the Zika virus is high," said Gavin Corcoran, Chief Medical Officer at Allergan. "Women in Puerto Rico urgently need contraceptives to help prevent unplanned pregnancies and postpone pregnancies and the donation of LILETTA and oral contraceptives is intended to meet these women's needs."

On April 13, 2016, scientists from CDC - Centers for Disease Control and Prevention announced that Zika virus is a cause of microcephaly and other severe fetal brain defects. 1 Women who do not want to get pregnant should talk with their doctor or healthcare provider about ways to prevent unintended pregnancy, including how to use birth control the right way every time. Women should consider safety, effectiveness, availability, and acceptability when choosing a birth control method.

"Medicines360's mission is to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location," said Jessica Grossman, MD, CEO of Medicines360. "We wanted to do our part to respond to this emergency now. Our donation helps these communities have access to safe and effective IUDs. Most importantly, LILETTA offers a long-term sustainable solution for public health clinics to continue to access a hormonal IUD at a $50 price after the crisis."

In Puerto Rico, 20 percent of the population is predicted to be infected by the Zika virus by the end of the year. An estimated 138,000 young Puerto Rican women have reported the desire to not get pregnant without access to effective birth control.2

LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to three years and is more than 99 percent effective. LILETTA is reversible and can be removed at any time by a healthcare provider. LILETTA and oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs) (including Zika virus).

Medicines360 and Allergan were granted FDA approval in February 2015 for LILETTA. By continuing to expand access to LILETTA in the U.S. and all over the world, Medicines360 and Allergan together remain committed to impacting the lives of women around the globe, removing the barriers of cost and access and increasing awareness to transform women's health and enable every woman to make appropriate medical choices.

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 (e.g., 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 (e.g., 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.

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 unique, global pharmaceutical company and a leader in a new industry model — Growth Pharma.  Allergan is focused on developing, manufacturing, and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines, and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

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.

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

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 Medicines360's and Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Medicines360 and Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Medicines360's and Allergan's current expectations depending upon a number of factors affecting Medicines360's and 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 Medicines360's and 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 Quarterly Report on Form 10-Q for the quarter ended March 30, 2016 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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.