Actavis And Medicines360 Announce U.S. Availability Of LILETTA (levonorgestrel-Releasing Intrauterine System) 52 Mg To Prevent Pregnancy For Up To Three Years

DUBLIN and SAN FRANCISCO, April 13, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT), a leading global pharmaceutical company and leader in women's health care, and Medicines360, a nonprofit women's health pharmaceutical company, announced today that LILETTA (levonorgestrel-releasing intrauterine system) 52 mg is now available in the U.S. for use by women to prevent pregnancy for up to three years.

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LILETTA was approved by the U.S. Food and Drug Administration (FDA) on February 26, 2015, based on the largest hormonal IUD trial conducted in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS). LILETTA is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.

"The availability of LILETTA marks another significant achievement in women's health," said Carolyn Westhoff, MD, M.Sc, Professor, Division Director, Family Planning and Preventive Services, Columbia University Medical Center. "It's critical that women have choices when it comes to their preferred contraception and I am pleased that I can offer my appropriate patients this new safe and effective option."

With the availability of LILETTA, IUD-appropriate women, regardless of financial status and insurance coverage, can now access this new safe and effective IUD through Actavis and Medicines360's partnership. LILETTA is now commercially available in doctor's offices in the U.S. and through this groundbreaking partnership, at a lower price for public health clinics enrolled in the 340B Drug Pricing Program.

"The commercial availability of LILETTA represents a remarkable next step for women's health in the U.S., providing IUD-appropriate women, regardless of income and insurance coverage, with a safe and effective contraceptive option," said Pamela Weir, Chief Operating Officer, Medicines360. "Through this truly innovative partnership, women will now have an accessible, affordable option for effective, long-term contraception."

"Actavis is committed to the continued development and commercialization of safe and effective contraceptives to address unmet needs in women's health," said Bill Meury, President, Actavis Branded Pharma. "LILETTA is a progestin-only intrauterine device with >99% efficacy demonstrated over 3 years. Our groundbreaking partnership with Medicines360 will provide increased access to this novel IUD to women across the private and public healthcare systems in the U.S."

About LILETTA

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.

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 aged 16-45 who received LILETTA. In women 16 to 35, LILETTA was found to be 99.45% effective in preventing pregnancy in women regardless of race, parity (previous births), or body mass index (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 (n=68) 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.

LILETTAIMPORTANT 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 less than 6 weeks 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, global pharmaceutical company and a leader in a new industry model Growth Pharma.  Actavis 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. 

Actavis markets a portfolio of best-in-class products that provide valuable treatments for the women's health, central nervous system, eye care, medical aesthetics, gastroenterology, 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. Actavis 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, Actavis 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.

Actavis intends to adopt a new global name Allergan pending shareholder approval in 2015.

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

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SOURCE Actavis plc