SAN FRANCISCO and DUBLIN, Feb. 15,
2017 /PRNewswire/ -- Medicines360, a nonprofit women's
health pharmaceutical company with a mission of expanding access to
quality medicines, and Allergan plc (NYSE:AGN), a leading global
pharmaceutical company, today announced a partnership with
340B-eligible health centers and other safety net providers in
Puerto Rico and Florida, both areas where there is local
transmission of the Zika virus, to make available their hormonal
contraceptive, LILETTA® (levonorgestrel-releasing
intrauterine system) 52 mg. LILETTA is an IUS, intrauterine system
(otherwise known as an intrauterine device or IUD), that is
approved for the prevention of pregnancy for up to three years.
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. LILETTA, is available at a lower cost to public
health clinics enrolled in the 340B Drug Pricing Program.
The health center partnership is part of the renewed Zika
response that Congress recently enacted into law, on a bi-partisan
basis. Specifically, Congress has appropriated an additional
$40 million for health centers in
Puerto Rico and the territories,
and the Health Resources and Services Administration (HRSA)
announced the availability of the funding on October 28, 2016.
"There is a clear and immediate need for effective contraceptive
options in Puerto Rico and
communities throughout the world to give women reproductive
choices. Where the risk of contracting the Zika virus is
high, the ability for a woman to plan if and when to become
pregnant is particularly important," said Gavin Corcoran, Chief Medical Officer at
Allergan. "Women in Puerto Rico
urgently need contraceptives to help prevent unplanned pregnancies
and to plan the timing of their pregnancies to occur as safely as
possible."
The partnership is designed to help reduce unintended
pregnancies in Puerto Rico and the
territories where risk of the Zika virus is high. An estimated
138,000 young Puerto Rican women have reported the desire to not
get pregnant and are not using an effective form of birth
control1. Additionally, the Centers for Disease Control
and Prevention (CDC) recently reported that 2,451 pregnant women
have been identified as Zika-infected in Puerto Rico and the territories.
On April 13, 2016, scientists from
the CDC announced that the Zika virus causes microcephaly and other
severe fetal brain defects. 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.
Allergan and Medicines360 intend to continue to partner with
HRSA and health centers in other areas in the United States at high risk for Zika
transmission this spring and summer.
"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. LILETTA offers
an option for public health clinics to continue to access a
hormonal IUD as the crisis spreads to other areas in the mainland
United States. The lower price we
offer will continue to serve these communities after the
crisis."
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 patient
cost and access barriers and increasing awareness to transform
women's health and enable every woman to make appropriate medical
choices.
ABOUT LILETTA
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; 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 (eg, 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 (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. 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.
For full prescribing information, visit www.LILETTA.com
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 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 bold,
global pharmaceutical company and a leader in a new industry model
– Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what it is right.
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 healthier lives
every day. 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 Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting 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 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 Annual Report
on Form 10-K for the year ended December 31,
2015 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016 (certain of 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.
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1 Tepper
NK, Goldberg HI, Bernal MI, et al. Estimating Contraceptive Needs
and Increasing Access to Contraception in Response to the Zika
Virus Disease Outbreak — Puerto Rico, 2016. MMWR Morb Mortal Wkly
Rep 2016;65:311–314.
DOI: http://dx.doi.org/10.15585/mmwr.mm6512e1.
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CONTACTS:
Medicines360 Media:
Shannon
Moore
(415) 486-3275
Allergan Investors:
Lisa
DeFrancesco
(862) 261-7152
Allergan Media:
Mark
Marmur
(862) 261-7558
Lisa Kim
(714) 246-3843
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visit:http://www.prnewswire.com/news-releases/medicines360-and-allergan-announce-partnership-with-health-centers-to-help-address-unintended-pregnancies-in-areas-impacted-by-zika-300407657.html
SOURCE Medicines360