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EMD Serono to Present Real-World Data Analyses at the Annual Pacific Coast Reproductive Society Meeting
Date:3/22/2017

ROCKLAND, Mass., March 22, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced two new real-world data analyses will be presented during the poster presentation session at the 65th Annual Pacific Coast Reproductive Society (PCRS) Meeting in Indian Wells, California on March 24th.  

The results being presented are based on analyses of a real-world database collected from July 2009 to December 2015 containing data from 15 fertility clinics across the United States.  Patients analyzed were from all 50 US states.  One presentation evaluates the impact of single embryo transfer (eSET) versus double embryo transfer (DET) on live birth rates and multiple rates.  The second presentation examines treatment patterns in the infertility patient journey that differ based on age, diagnosis and year of treatment.

"Analysis of real-world data can provide important information on clinical and laboratory trends and associated outcomes," said Mary Mahony, PhD, Vice President, Fertility and Endocrinology, EMD Serono. "Our partnership with some of the largest fertility centers in the United States has allowed us to gather relevant real-world data that we feel provides important insights for healthcare providers and the infertility community as we seek to improve patient outcomes as well as the patient experience."

EMD Serono will also host a booth at the PCRS Meeting that will feature information about the company's Fertility Technologies division, which launched its first product last year with Gidget™, a hand-held witnessing system for the IVF laboratory that provides visual lab workflow management and support for traceability and audit reporting, as well as EMD Serono's GONAL-f® [follitropin alfa for injection], which  is the world's first and most-widely prescribed recombinant human follicle stimulating hormone (r-hFSH).

Additional meeting information and full abstracts are available on the PCRS meeting website.

Poster Presentation Information:

  • (Poster# 11) Weighing The Impact of eSET Versus DET On Live Birth Rates And Associated Multiple Rates For 38,020 Day 5/6 Transfers In A Large Real-World Database. Friday, March 24, 2017 6:00 – 6:45 p.m. PST. Location: Exhibit Hall.
  • (Poster#62) Treatment Decision Trends in The Infertility Patient Journey from 78,958 Cycles in a Real-World Database: Impact of Age, Diagnosis, and Year of Treatment. Friday, March 24, 2017 6:45 – 7:30 p.m. PST. Location: Exhibit Hall.

CONSUMER INDICATION and IMPORTANT RISK INFORMATION
GONAL-f® (follitropin alfa for injection) and GONAL-f® RFF (follitropin alfa for injection)
IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF GONAL-f® (follitropin alfa for injection) and GONAL-f® RFF* (follitropin alfa for injection)

What are the uses of Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF* (follitropin alfa for injection)?
Gonal-f® Multi-Dose and Gonal-f® RFF are 2 products that contain follitropin alfa, which is similar to the human hormone follicle-stimulating hormone, referred to as FSH. FSH belongs to a group of human reproductive hormones.

Gonal-f® Multi-Dose and Gonal-f® RFF are used in certain infertile women to help with ovulation (production and release of a mature egg) and pregnancy. Gonal-f® will not help women whose ovaries no longer work because of a condition called Primary Ovarian Failure. Gonal-f® may also be used in women who are in an Assisted Reproductive Technology (ART) program such as in vitro fertilization to help their ovaries make more eggs.

Gonal-f® Multi-Dose can also be prescribed to increase sperm production in men with a rare condition that affects sperm production.

Both products should be prescribed only by doctors specializing in infertility problems and their treatment.

Who should not use Gonal-f® and Gonal-f® RFF?
Gonal-f® Multi-Dose and Gonal-f® RFF should not be used in patients who are pregnant or think they might be pregnant, in patients with primary ovarian failure (the ovaries no longer produce eggs), or in patients with allergies to recombinant human FSH products or any other ingredients in the medication. Patients with cancer of the sex organs or brain, or with uncontrolled thyroid or adrenal disease, should not use Gonal-f® Multi-Dose or Gonal-f® RFF. Women with a history of abnormal bleeding from the uterus or vagina or with swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment.

What are the possible side effects of Gonal-f® and Gonal-f® RFF?
The lowest dose expected to achieve the desired results should be used. A doctor should monitor a woman's response often to avoid overdose, which can lead to serious side effects, including blood clots. Women should contact their doctor if severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting, or weight gain are experienced during treatment. These could be signs of a rare but serious condition known as Ovarian Hyperstimulation Syndrome, or OHSS, which can result in hospitalization.

Use of Gonal-f® Multi-Dose or Gonal-f® RFF by a woman can be associated with fertilization of more than 1 egg. This can lead to complications for the woman and the birth of 2 or more babies.

The most common side effects reported by women were headache, ovarian cysts, upset stomach, and sinus infection. The most common side effects reported by men taking Gonal-f® Multi-Dose were skin pimples, breast pain and growth, and tiredness. Injections may cause some discomfort. Full prescribing information for Gonal-f® can be found at: http://www.emdserono.com/ms.country.us/en/images/Gonal-f_RFF_Redi-ject_PI_tcm115_140008.pdf?Version=

About EMD Serono, Inc.
EMD Serono is the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has 1,200 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com

Your Contact
Melissa Manganello       781.681.2393

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