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News Release
Dr. Raphaela Farrenkopf +49 6151 72-2274

November 13, 2017

Not intended for U.S. and UK based media

Merck Receives FDA Approval for New GONAL-f®

Prefilled Pen
• New pen is easy-to-learn and easy-to-use, supporting the one in six
couples affected by infertility in the U.S.1
• Insights of patients, nurses and doctors helped to evolve the
product

Darmstadt, Germany, November 13, 2017 - Merck, a leading science and technology
company, today announced that the company received approval for a new version
of GONAL-f ® (follitropin alfa injection) prefilled pen from the U.S. Food and Drug
Administration (FDA). Known as GONAL-f ® RFF Redi-jectTM* prefilled pen in the U.S.
and originally approved by the FDA in 2013, the new version of the pen is easy-to-
learn and easy-to-use.

“Aspiring to be an integrated fertility treatment partner, our strategy focuses on

developing user-friendly treatment options for patients,” said Luciano Rossetti, Head
of Global Research and Development, at the biopharma business of Merck. “We
understand that the best drivers for innovation come from insights from the people
using our products. Their advice was a significant factor in the development of the
new version of the GONAL-f® prefilled pen.”

To date, an estimated 2.5 million babies have been brought to the world with the
help of Merck fertility products and services.2 GONAL-f ® is the only gonadotropin
that comes in prefilled, ready-to-use pen in the U.S.3 The new GONAL-f ® pen, like
its predecessor, enables a fine-tuning of treatment allowing for minimum increments
of 12.5 IU to titrate a wide range of doses and precisely target the dosing to patients’
needs.4 In addition, its new design features include an amendment to the dose

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Frankfurter Strasse 250 Head Media Relations -62445

64293 Darmstadt · Germany Spokesperson: -9591 / -7144 / -6328
Hotline +49 6151 72-5000 Fax +49 6151 72 3138
merckgroup.com media.relations@merckgroup.com
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Patients suffering from infertility are a key focus for Merck as the company
continuously seeks to expand its fertility offering. The latest version of the
GONAL-f ® prefilled pen is the most recent addition to Merck’s growing portfolio to
support women and couples faced with infertility in the U.S., where one in six
couples is affected by infertility.1

References
1. Thoma, M.E. et al. Prevalence of infertility in the United States as estimated by the
current duration approach and a traditional constructed approach. Fertility and Sterility
2013 9 (5):1324-1331
2. Data on file. Market Data Analytics. September 2015
3. Data on file. IMS MIDAS database Q4 2016, May 2017
4. GONAL-f® prefilled pen, Instructions for use. EU product information for GONAL-f®
solution for injection in a prefilled pen. December 2015

*Revised Formulation Female

A bout GONA L-f ®

GO NAL-f ® (follitropin alfa inje ction) is a re com binant hum an follicle-stimulating hormone (r-hFSH)
approved for the tre atment fe male infertility and a rare form of m ale infertility. It is pre scribed to
supplement or re place naturally occurring follicle-stimulating hormone (FSH), an e ssential hormone to
tre at infertility. GONAL-f® has been approved for use in the tre atment of infertility in Europe since 1995
and since 1997 in the Unite d States, and is available in m ore than 100 countries worldwide . It is the
m ost wide ly pre scribed gonadotropin in the world. Not all indications are approved in all markets for all
product offe rings.

Our Pens
O ur pe ns consist of pre filled re ady-to-use pe ns for GO NAL-f ® 300 IU, 450 IU, and 900 IU, and
O VITRELLE®/OVIDREL ® 250 m cg and Pergoveris ® 300IU, 450IU and 900IU. The pens we re developed
based on fe edback from healthcare professionals and those e xperiencing fe rtility problems, in order to
e ase the te aching, le arning and use of the pe ns. Not all products are approve d in all m ark e ts.

All Me rck Press Releases are distributed by e-mail at the same time they become available on the Merck
W e bsite. Please go to www.m e rck group.com/subscribe to re gister online, change your se le ction or
discontinue this se rvice .

A bout Merck
Me rck is a le ading science and te chnology company in healthcare, life science and performance m aterials.
Around 50,000 e mployees work to furthe r de velop te chnologies that improve and e nhance life – from
biopharmaceutical therapies to tre at cancer or m ultiple sclerosis, cutting-edge systems for scie ntific
re se arch and production, to liquid crystals for sm artphones and LC D te le visions. In 2016, Merck
ge ne rate d sale s of € 15.0 billion in 66 countrie s.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family
re m ains the majority owne r of the publicly listed corporate group. Merck , Darmstadt, Germany holds the
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News Release

global rights to the Merck name and brand. The only e xceptions are the United States and C anada, where
the com pany ope rate s as EMD Se rono, Millipore Sigm a and EMD Pe rform ance Mate rials.

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