Allergan (AGN), Medicines360 Launch LILETTA Single-Handed Inserter
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Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a nonprofit global women's health pharmaceutical company, today announced the launch of the new LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg IUD single-handed inserter (intrauterine device), for use by women to prevent pregnancy for up to three years. The launch and availability of the single-handed inserter follows the U.S. Food and Drug Administration (FDA) approval received in January 2016.
"As a leader in women's healthcare, Allergan is committed to providing our customers with the most efficient technology and support needed to educate their patients about their reproductive health," said David Nicholson, PhD, Chief R&D Officer at Allergan. "The launch of the LILETTA single-handed inserter continues to demonstrate our commitment to innovation in women's health and serves as another bold example of providing options to better serve our customers and patients."
"We are excited to bring to market the new LILETTA inserter and anticipate that the single-handed process may lead to broader use by healthcare providers, thereby increasing the number of women who have access to this effective contraceptive," said Jessica Grossman, MD, CEO of Medicines360. "Specifically, the new LILETTA inserter includes an ergonomic design allowing for single-handed insertion that can be used with either hand; a bendable tube to accommodate the anatomy of the patient during insertion; and the ability to reload the device if needed before insertion."
A comprehensive product demonstration program is being implemented by Allergan and Medicines360 to help inform clinicians in the private and public sectors about the new inserter.
The approval of the new single-handed inserter 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, the same trial that supported the initial approval of LILETTA. LILETTA was shown to be 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 Body Mass Index (BMI) and can be inserted on the same day she visits the clinic, providing that she is not pregnant. During the ACCESS IUS clinical trial, the success rate for insertions with the new single-handed inserter was 99.2%.
LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to three years and is greater than 99% effective. LILETTA is not permanent, it can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception. LILETTA can be used in women regardless of whether or not they've birthed a child. Allergan initially launched LILETTA in partnership with Medicines360, a non-profit global pharmaceutical company whose mission is to provide access to medicines for women regardless of their socioeconomic status, insurance status, or geographic location. The new LILETTA single-handed inserter with an optimized package received approval in May 2016, and will succeed the two-handed inserter, which was approved by the U.S. FDA in February, 2015.
LILETTA systems with the single-handed inserter 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.
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