Actavis and Medicines360 Announce FDA Approval of LILETTA™ (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Three Years

DUBLIN and SAN FRANCISCO, Feb. 27, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval of LILETTA™ (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration (FDA) for use by women to prevent pregnancy for up to three years. LILETTA is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.

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Actavis and Medicines360's groundbreaking partnership will allow women, regardless of income and insurance coverage, to access this new and effective contraceptive option. Through the collaboration, LILETTA will be available in the U.S. commercially as well as at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

"At Actavis, we are committed to developing alternative forms of contraceptive options. With the FDA's approval of LILETTA, we are pleased to offer women a novel IUD which provides three years of safe and effective contraception," said David Nicholson, PhD., Executive Vice President, Actavis Global Brands R&D.

"The FDA's approval of LILETTA marks an important milestone for women, providers, and the reproductive health community.  LILETTA was designed from the beginning to be accessible by women, regardless of socioeconomic status," said Pamela Weir, Chief Operating Officer, Medicines360. "In the past, many barriers including expensive upfront costs or lack of insurance coverage have prevented women from obtaining IUDs."   

The approval of LILETTA was based on the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), conducted in the U.S. with 1,751 enrolled women receiving LILETTA.  LILETTA was safe and effective for a broad range of women, with a cumulative three year efficacy rate of 99.45 percent.  LILETTA is indicated for women regardless of parity or BMI.

LILETTA is a small, flexible plastic T-shaped system which is 32 mm x 32 mm in size. It works to prevent pregnancy by slowly releasing levonorgestrel (LNG), a progestin, at an initial release rate of 18.6 mcg/day with an average in vivo release rate of LNG of approximately 15.6 mcg/day over a period of three years. Generally, LILETTA can be inserted at any time if the provider is reasonably certain that the woman is not pregnant. While LILETTA is intended for use up to three years, it can be removed by a healthcare professional at any time. LILETTA can be replaced at the time of removal with a new LILETTA, if continued contraceptive protection is desired.

"This new hormonal IUD was proven more than 99 percent effective in the largest ever IUD trial conducted in the U.S. It offers a long-term, highly-effective yet reversible option to prevent pregnancy for many women regardless of whether or not they've had a child before," said David L. Eisenberg, M.D., assistant professor of obstetrics and gynecology at Washington University in St. Louis and principal investigator and lead author of the ACCESS IUS study. "This long-acting reversible contraceptive is a desirable option for women looking to prevent pregnancy."

Actavis and Medicines360 expect that LILETTA will be available for use in the U.S. by Q2 2015.

About the Clinical Trial for LILETTA

The approval of LILETTA is supported by the largest hormonal IUD trial (ACCESS IUS) conducted in the U.S. designed to reflect the U.S. population. This multicenter open-label clinical trial included 1,751 women who received LILETTA. LILETTA was found to be 99.45 percent effective in preventing pregnancy in women regardless of age, parity (previous births), or BMI. The trial is ongoing to evaluate the use of LILETTA for up to four, five and seven years.

LILETTA was studied in women aged 16-45, with a BMI range of 15.8kg/m² - 61.6kg/m² (26.9 kg/m² mean BMI) across women of various races and ethnicities. Most women were Caucasian (78.4 percent) or Black/African American (13.3 percent); 14.7 percent of women were of Hispanic ethnicity. Nearly 58 percent of trial participants were nulliparous (had not previously given birth), the largest percentage of nulliparous IUD patients ever studied. 

In an analysis of women who discontinued the study early, 97 percent returned to menses within three months after LILETTA was removed. Furthermore, in a group of women trying to conceive, 87 percent became pregnant within one year of removal. Additionally, some women were able to conceive as soon as two weeks after removal (12 days). Approximately 19 percent of women treated with LILETTA experienced amenorrhea (absence of menstruation) within one year of treatment and more than one-third experienced amenorrhea by the third year of treatment.

The incidence of ectopic pregnancy in the clinical trial with LILETTA, which excluded women with a history of ectopic pregnancy who did not have a subsequent intrauterine pregnancy, was approximately 0.12 percent per 100 woman-years.

LILETTA™ IMPORTANT SAFETY INFORMATION

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; liver disease, including 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 IUD; 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. 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

IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. 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. PID is often associated with sexually transmitted infections (STIs); LILETTA™ does not protect against STIs, including HIV.

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.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUDs like LILETTA™ are expulsion, sepsis, and perforation. Perforation may reduce contraceptive efficacy. 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.

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

In clinical trials of LILETTA™ the most common adverse reactions (≥5% users) are 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 discomfort or pain (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 Medicines360

Medicines360 is an innovative nonprofit women's health pharmaceutical company that develops quality healthcare products for a broad range of women and expands access through novel approaches.  By partnering with pharmaceutical companies, Medicines360 will demonstrate that taking a socially responsible approach is good for business. For more information, visit www.medicines360.org.

About Actavis

Actavis plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world. 

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.  The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.  Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.actavis.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 Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' 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 Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Annual Report on Form 10-K for the year ended December 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

Actavis Contacts:
Investors
Lisa DeFrancesco
(862) 261-7152

Media:
Charlie Mayr
(862) 261-8030

David Belian
(862) 261-8141

Medicines360 Contact:
Caren Begun
856-424-2023

SOURCE Actavis plc

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