U.S. FDA Approves Bayer's Skyla™ (Levonorgestrel-Releasing Intrauterine System) 13.5 mg For Prevention Of Pregnancy For Up To

   U.S. FDA Approves Bayer's Skyla™ (Levonorgestrel-Releasing Intrauterine
      System) 13.5 mg For Prevention Of Pregnancy For Up To Three Years

First new IUD (intrauterine device) to enter market in more than a decade

Approval of Skyla expands Bayer's IUD portfolio

PR Newswire

WAYNE, N.J., Jan. 9, 2013

WAYNE, N.J., Jan. 9, 2013 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals
Inc. today announced that the U.S. Food and Drug Administration (FDA) approved
Skyla^™ (levonorgestrel-releasing intrauterine system) 13.5 mg, a new
hormone-releasing system that is placed in the uterus for the prevention of
pregnancy for up to three years.[1]

(Photo: http://photos.prnewswire.com/prnh/20130109/MM19804-a)

(Photo: http://photos.prnewswire.com/prnh/20130109/MM19804-b) 

"Research shows that nearly 50 percent of pregnancies in the U.S. are
unintended,^2 which emphasizes the need for increased education and access to
effective birth control options," ^ said Anita L. Nelson, M.D., Professor of
Obstetrics and Gynecology at Harbor-UCLA Medical Center, Torrance, CA. "Skyla
is more than 99 percent effective at preventing pregnancy ^ and may be
appropriate for women who want a birth control method that they do not have to
take daily. Further, Skyla may be used by women whether or not they have ever
had a child, representing an important new choice for women who don't want to
become pregnant for up to three years."

Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a
progestin hormone called levonorgestrel. ^ The size of the Skyla T-body is
28mm x 30mm and the outer diameter of the placement tube is 3.8mm. Because
Skyla slowly releases levonorgestrel into the uterus, only small amounts of
the hormone enter the blood. During the first three to six months of using
Skyla, women may experience irregular periods and an increase in the number of
bleeding days. Women may also have frequent spotting or light bleeding. Some
women may have heavy bleeding during this time. After using Skyla for a while,
the number of bleeding and spotting days is likely to lessen, and there is a
small chance that periods may stop altogether.^1,3

Women can have Skyla placed by a healthcare provider during an in-office
visit. Skyla is intended for long-term use for up to three years but may be
removed by a healthcare provider at any time. Women could become pregnant as
soon as Skyla is removed, so they should use another method of birth control
if they do not want to become pregnant. About 77% of women who want to become
pregnant will become pregnant sometime in the first year after Skyla is

"The approval of Skyla expands Bayer's IUD portfolio and highlights our
continued commitment to empower women with a variety of birth control options
at different reproductive stages of their lives," said Pamela A. Cyrus, M.D.,
Vice President and Head of U.S. Medical Affairs, Bayer HealthCare
Pharmaceuticals. "We are pleased to bring the first new IUD to market in the
U.S. in 12 years, and to provide women who are seeking contraception with an
important new and effective option to consider with their healthcare

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available
by prescription the week of February 11.

About the Clinical Trial for Skyla^1
The approval of Skyla is supported by data from a Phase 3 trial that included
1,432 women aged 18-35 who received Skyla, of which 38.8% (556) had not yet
had a child. The trial was a multicenter, multinational, randomized open-label
study conducted in 11 countries in Europe, Latin America, the U.S. and Canada.
Women less than six weeks postpartum, with a history of ectopic pregnancy,
with clinically significant ovarian cysts or with HIV or otherwise at high
risk for sexually transmitted infections were excluded from the trial.

The pregnancy rate calculated as the Pearl Index (PI) in women aged 18-35
years was the primary efficacy endpoint used to assess contraceptive
reliability. The PI was calculated based on 28-day equivalent exposure cycles;
evaluable cycles excluded those in which back-up contraception was used unless
a pregnancy occurred in that cycle. Skyla-treated women provided 15,763
evaluable 28-day cycle equivalents in the first year and 39,368 evaluable
cycles over the three-year treatment period. The PI estimate for the first
year of use based on the five pregnancies that occurred after the onset of
treatment and within seven days after Skyla removal or expulsion was 0.41 with
a 95% upper confidence limit of 0.96. The cumulative three-year pregnancy
rate, based on 10 pregnancies, estimated by the Kaplan-Meier method was 0.9
per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.

Of Skyla-treated women, 21.9% discontinued the study treatment due to an
adverse event. Most common adverse reactions (occurring in greater than or
equal to 5% users) were, vulvovaginitis (20.2%), abdominal/pelvic pain
(18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%),
dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased bleeding (7.8%)
and nausea (5.5%).

Other serious adverse reactions were also observed, including
ectopic/intrauterine pregnancy, life-threatening infections, pelvic
inflammatory disease (PID), perforation and expulsion.

Important Safety Information for Skyla (levonorgestrel-releasing intrauterine
system) 13.5 mg

If you have a pelvic infection, get infections easily, or have certain
cancers, don't use Skyla. Less than 1% of users get a serious infection called
pelvic inflammatory disease.

If you have persistent pelvic or stomach pain or if Skyla comes out, tell your
doctor. If Skyla comes out, use back-up birth control. Skyla may attach to or
go through the uterus and cause other problems.

Pregnancy while using Skyla is uncommon but can be life threatening and may
result in loss of pregnancy or fertility. Ovarian cysts may occur but usually

Bleeding and spotting may increase in the first few months, and remain
irregular. Over time, periods are likely to become shorter and lighter, or may

Skyla does not protect against HIV or STDs.

Only you and your healthcare provider can decide if Skyla is right for you.
Skyla is available by prescription only.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call

For additional information about Skyla, please see full prescribing
information at www.skyla-us.com.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals
business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare
is one of the world's leading, innovative companies in the healthcare and
medical products industry, and combines the activities of the Animal Health,
Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty
pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for
Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and
Women's Healthcare. The company's aim is to discover and manufacture products
that will improve human health worldwide by diagnosing, preventing and
treating diseases.

BAYER^® and the Bayer Cross^® are registered trademarks of Bayer. Skyla is a
trademarkof Bayer.

Intended for U.S. media only

Media Contact:
Marcy Funk, Tel. +1 (973) 305 5385
E-Mail: marcy.funk@bayer.com

Forward-Looking Statement
This news release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management. Various
known and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial situation,
development or performance of the company and the estimates given here. These
factors include those discussed in Bayer's public reports which are available
on the Bayer website at www.bayer.com. The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments.

^[1] Skyla Prescribing Information, January 2013
^[2] Mosher WD, Jones J. Use of contraception in the United States: 1982–2008.
National Center for Health Statistics. Vital Health Stat 23(29). 2010.
"Introduction" Available at
http://www.cdc.gov/nchs/data/series/sr_23/sr23_029.pdf. Accessed on 1/2/13.
^[3] Skyla Patient Prescribing Information, January 2013

SOURCE Bayer HealthCare

Website: http://www.bayer.com
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