Medicines360, Afaxys Partner to Expand Public Health Access to LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg

SAN FRANCISCO and CHARLESTON, S.C., Sept. 6, 2018 /PRNewswire/ -- Medicines360 and Afaxys Pharma, LLC, two mission-driven, socially conscious women's health pharmaceutical companies, today announced their collaboration to promote Medicines360's intrauterine system (IUS), LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg, which is available to U.S. public health clinics enrolled in the 340B Drug Pricing Program at a stable, low price. Through this alliance, Medicines360, a nonprofit, and Afaxys, the number one provider of oral and emergency contraceptives purchased by U.S. public health clinics, will co-promote LILETTA to the 340B-participating public health sector, helping to expand access to the full range of FDA-approved contraception for women.

"Unintended pregnancy rates are highest among low-income women," said Jessica Grossman, MD, CEO of Medicines360. "Unfortunately, affordable access to LARCs is an issue for many clinics where low-income women seek care for their contraceptive needs. We believe that this alliance will expand contraceptive access for appropriate women."

LILETTA, a long-acting reversible contraceptive for up to 4 years, is commercially available in the U.S. public and private sectors. Medicines360's collaboration with Afaxys will double the size of the team dedicated to supporting the 340B-participating public health sector. The alliance's goal is to facilitate affordable access to LILETTA for women who seek care in these clinics. Long-acting reversible contraceptives (LARCs), including IUSs/IUDs, are among the most effective forms of family planning, according to the CDC and the American Congress of Obstetricians and Gynecologists (ACOG).

"This collaboration underscores our shared commitment to women's health and we look forward to serving more public health providers and their patients, together with Medicines360. We are always seeking opportunities to broaden contraceptive offerings, and, through this partnership, we can make one of the most effective forms of contraception more widely available to underserved women ?regardless of their income or insurance coverage," said Afaxys CEO, Ronda Dean.

LILETTA is the subject of an ongoing U.S.-based Phase 3 hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS [intrauterine system]), with 1,751 U.S. women receiving LILETTA. In this study, LILETTA was shown to be greater than 99 percent effective in preventing pregnancy in a broad range of women, regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child) for up to four years.

ABOUT LILETTA^®

Indication

LILETTA is a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to 4 years. The system should be replaced after 4 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 and would be incompatible with correct IUS placement; known or suspected breast cancer or other hormone-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; infected abortion in the past 3 months; unexplained uterine bleeding; current IUS; acute pelvic inflammatory disease (PID) or endometritis 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 or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing LILETTA if 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. One woman 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 and endometritis are 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 or endometritis and that these infections 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 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 is suspected, locate and remove LILETTA as soon as possible. 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 LILETTA clinical trial, the most common adverse reactions (?5% users) were vaginal bacterial infections (17.9%), vulvovaginal mycotic infections (17.9%), acne (14.5%), nausea or vomiting (9.4%), dyspareunia (8.8%), headache (8.7%), breast tenderness or pain (8.0%), pelvic discomfort or pain (7.9%), anxiety (7.6%), abdominal pain or discomfort (7.4%), depression (6.4%), increased weight (5.6%), dysmenorrhea (5.6%), mood changes (5.5%), vaginal discharge (5.3%), and back pain (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.

Please see full Prescribing Information.

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.

ABOUT AFAXYS

Afaxys, a name which comes from "affordable access," is a first-of-its-kind, mission-driven, socially conscious business enterprise dedicated to serving the women's healthcare needs of public health providers and their patients. The number one provider of oral and emergency contraceptives in U.S. clinics, Afaxys manages the supply needs of public health providers, ensuring customers receive affordable, reliable access to the products and services they need to care for patients. Since 2005, Afaxys has operated a Group Purchasing Organization, which negotiates favorable pricing across a broad base of healthcare products and services so its customers have access to best-in-class suppliers and service providers. In 2013, Afaxys launched its pharmaceutical division, Afaxys Pharma, LLC, bringing a portfolio of FDA-approved oral and emergency contraceptives to the public health sector. These branded and generic products are available to the public health sector including public health clinics, college and university health centers, community health centers, non-retail prescribers, as well as city, county, state and federal facilities, at prices intended to be consistently lower than those currently on the market. Most recently, Afaxys launched its newest business, eMarketplace, which offers a cloud-based procurement system, saving public health clinics time and money. To learn more, visit www.afaxys.com.

SOURCE Medicines360