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EMD Serono Receives FDA Approval for Redesigned Fertility Pen

  EMD Serono Receives FDA Approval for Redesigned Fertility Pen

  *Gonal-f^® RFF* Redi-ject™ (follitropin alfa injection) incorporates
    updates and new features developed from patient and provider feedback

Business Wire

ROCKLAND, Mass. -- October 17, 2013

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced
today that the U.S. Food and Drug Administration (FDA) approved Gonal-f^® RFF*
Redi-ject™ (follitropin alfa injection), a disposable pre-filled drug injector
pen intended for the subcutaneous injection of a liquid formulation of
Gonal-f^® RFF.

“EMD Serono is excited and proud to bring the Gonal-f^® RFF Redi-ject™
(follitropin alfa injection) to the market. This device was designed with key
features based on feedback we received from Healthcare Professionals (HCPs),
patients, and significant others,” said Craig Millian, Senior Vice President,
Head of the US Fertility Franchise at EMD Serono. “Bringing the Gonal-f^® RFF
Redi-ject™ to market aligns directly to our mission, which is to create,
innovate, and advocate for people who want to have a child. EMD Serono has a
long heritage of fertility expertise, and we will continue to invest in
emerging science, patient-centric programs, and our existing product portfolio
to achieve our goal of reducing barriers to treatment.”

The Gonal-f^® RFF Redi-ject™ will be available in December 2013 in three pen
sizes: 300 IU, 450 IU and 900 IU.

For more information about the Gonal-f^® RFF Redi-ject™, please call Fertility
Lifelines at 1-866- 538-7879.

For information about Gonal-f^® RFF Redi-ject™, please click here to visit
emdserono.com for the Prescribing Information. Patients should consult their
health care provider for additional information.

*Revised Formulation Female

About Gonal-f^® RFF Redi-ject™ (follitropin alfa injection)

Gonal-f^® RFF Redi-ject™ (follitropin alfa injection) is indicated for:
Induction of ovulation and pregnancy in oligo-anovulatory women in whom the
cause of infertility is functional and not due to primary ovarian failure,
development of multiple follicles in ovulatory women as part of an Assisted
Reproductive Technology (ART) cycle. Prior to initiation of treatment with
Gonal-f^® RFF Redi-ject™: Women should have a complete gynecologic and
endocrinologic evaluation and diagnose the cause of infertility. Primary
ovarian failure and potential pregnancy should be excluded. Tubal patency
should be demonstrated.

Gonal-f^® RFF Redi-ject™ is contraindicated in women who exhibit:
Hypersensitivity to recombinant FSH preparations or one of their excipients,
high levels of FSH indicating primary gonadal failure, pregnancy, uncontrolled
non-gonadal endocrinopathies, sex hormone dependent tumors of the reproductive
tract and accessory organs, tumors of pituitary gland or hypothalamus,
abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement
of undetermined origin, not due to polycystic ovary syndrome.

This product should only be prescribed by physicians specializing in fertility
or reproductive health and only when appropriate monitoring facilities are
available. The lowest effective dose should be used. Gonal-f^® RFF Redi-ject™
is a potent gonadotropin capable of causing Ovarian Hyperstimulation Syndrome
(OHSS) with or without pulmonary or vascular complication and multiple births.

Serious systemic hypersensitivity reactions, including anaphylaxis, have been
reported in the postmarketing experience with Gonal-f^® and Gonal-f^® RFF.
Symptoms have included dyspnea, facial edema, pruritis, and urticaria. If an
anaphylactic or other serious allergic reaction occurs, initiate appropriate
therapy including supportive measures if cardiovascular instability and/or
respiratory compromise occur, and discontinue further use.

In order to minimize the hazards associated with abnormal ovarian enlargement
that may occur with Gonal-f^® RFF Redi-ject™ therapy, treatment should be
individualized and the lowest effective dose should be used. Use of ultrasound
monitoring of ovarian response and/or measurement of serum estradiol levels is
important to minimize the risk of ovarian stimulation.

If the ovaries are abnormally enlarged on the last day of Gonal-f^® RFF
Redi-ject™ therapy, hCG should not be administered in order to reduce the
chance of developing Ovarian Hyperstimulation Syndrome (OHSS). Intercourse
should be prohibited in women with significant ovarian enlargement after
ovulation because of the danger of hemoperitoneum resulting from rupture of
ovarian cysts.

OHSS is a medical entity distinct from uncomplicated ovarian enlargement and
may progress rapidly to become a serious medical event. OHSS occurs after
gonadotropin treatment has been discontinued and it can develop rapidly,
reaching its maximum about 7 to 10 days following treatment. Cases of OHSS are
more common, more severe, and more protracted if pregnancy occurs; therefore,
women should be assessed for the development of OHSS for at least two weeks
after hCG administration. If severe OHSS occurs, treatment must be stopped and
the patient should be hospitalized and treated by a physician experienced in
the management of this syndrome or in the management of fluid and electrolyte
imbalances. During clinical trials with Gonal-f^® RFF, OHSS occurred in 7.2%
of 83 women and 4.6% of 237 women treated with Gonal-f^® RFF for ovulation
induction and during Assisted Reproductive Technology, respectively.

Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress
syndrome and exacerbation of asthma) have been reported in women treated with
gonadotropins. In addition, thromboembolic events both in association with,
and separate from OHSS have been reported in women treated with gonadotropins.
Women with generally recognized risk factors for thrombosis, such as personal
or family history, severe obesity, or thrombophilia, may have an increased
risk of venous or arterial thromboembolic events, during or following
treatment with gonadotropins. Sequelae of such reactions have included venous
thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular
occlusion (stroke), and arterial occlusion resulting in loss of limb and
rarely in myocardial infarctions. In rare cases, pulmonary complications
and/or thromboembolic reactions have resulted in death. In women with
recognized risk factors, the benefits of ovulation induction and assisted
reproductive technology need to be weighed against the risks. It should be
noted that pregnancy also carries an increased risk of thrombosis.

Ovarian torsion has been reported after treatment with gonadotropins. This may
be related to OHSS, pregnancy, previous abdominal surgery, past history of
ovarian torsion, previous or current ovarian cyst and polycystic ovaries.
Damage to the ovary due to reduced blood supply can be limited by early
diagnosis and immediate detorsion.

Multi-fetal gestation and births have been reported with all gonadotropin
therapy including therapy with Gonal-f^® RFF.

During clinical trials with Gonal-f^® RFF, multiple births occurred in 20% of
live births in women receiving therapy for ovulation induction and 35.1 % of
live births in women undergoing ART.

The woman and her partner should be advised of the potential risk of
multi-fetal gestation and birth before beginning therapy with Gonal-f^® RFF
Redi-ject™.

The incidence of congenital malformations after some ART [specifically in
vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be
slightly higher than after spontaneous conception. This slightly higher
incidence is thought to be related to differences in parental characteristics
(e.g., maternal age, maternal and paternal genetic background, sperm
characteristics) and to the higher incidence of multi-fetal gestations after
IVF or ICSI. There are no indications that the use of gonadotropins during IVF
or ICSI is associated with an increased risk of congenital malformations.

Since infertile women undergoing ART often have tubal abnormalities, the
incidence of ectopic pregnancy may be increased. Early confirmation of
intrauterine pregnancy should be determined by β-hCG testing and transvaginal
ultrasound.

The risk of spontaneous abortion (miscarriage) is increased with gonadotropin
products. However, causality has not been established. The increased risk may
be a factor of the underlying infertility.

There have been infrequent reports of ovarian neoplasms, both benign and
malignant, in women who have had multiple drug therapy for controlled ovarian
stimulation, however, a causal relationship has not been established.

The combination of both ultrasound and serum estradiol measurement are useful
for monitoring follicular growth and maturation, timing of the ovulatory
trigger, detecting ovarian enlargement and minimizing the risk of the OHSS and
multiple gestation.

The most common adverse reactions (≥5%) in ovulation induction include:
headache, abdominal pain, and ovarian hyperstimulation. The most common
adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal
enlargement, headache, and injection site reactions (pain, bruising).

Advise patients to follow the Instructions for Use and not share the device or
reuse needles.

Before prescribing Gonal-f^® RFF Redi-ject™, please read the accompanying
Prescribing Information.

About EMD Serono, Inc.

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader
in the US biopharmaceutical arena, integrating cutting-edge science with
unparalleled patient support systems to improve people's lives. The company
has strong market positions in neurodegenerative diseases, endocrinology and
in reproductive health. In addition, EMD Serono is growing its expertise and
presence in the area of oncology, with more than 15 projects currently in
development. With a clear focus on the patient and a leadership presence in
the biopharmaceutical industry, EMD Serono’s US footprint continues to grow,
with approximately 1,000 employees around the country and fully integrated
commercial, clinical and research operations in the company’s home state of
Massachusetts.

For more information, please visit www.emdserono.com.

About Merck KGaA

Merck is a leading pharmaceutical, chemical and life science company with
total revenues of € 11.2 billion in 2012, a history that began in 1668, and a
future shaped by approx. 38,000 employees in 66 countries. Its success is
characterized by innovations from entrepreneurial employees. Merck's operating
activities come under the umbrella of Merck KGaA, in which the Merck family
holds an approximately 70% interest and free shareholders own the remaining
approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated
and has been an independent company ever since.

For more information, please visit www.merckserono.com or www.merckgroup.com.

About EMD Serono Fertility

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader
in the US biopharmaceutical arena, integrating cutting-edge science with
unparalleled patient support systems to improve people’s lives. The company’s
US footprint continues to grow, with more than 850 employees around the
country and fully integrated commercial, clinical, and research operations in
the company’s home state of Massachusetts. With a focus on specialized
therapeutic areas, including reproductive health, neurology and metabolic
endocrinology, the company is committed to growing existing therapeutic areas
and entering into new ones by developing both biotherapeutic proteins and
small molecules.

Contact:

For EMD Serono, Inc.
Kristen LaVerghetta, 781-681-2065
 
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