Merck Receives FDA Approval for New GONAL-f® Prefilled Pen

Darmstadt, Germany (ots/PRNewswire) -

- 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

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.

(Photo: http://mma.prnewswire.com/media/602538/Merck_New_Pen.jpg )

"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 display window for
readability.

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

About GONAL-f®

GONAL-f® (follitropin alfa injection) is a recombinant human
follicle-stimulating hormone (r-hFSH) approved for the treatment
female infertility and a rare form of male infertility. It is
prescribed to supplement or replace naturally occurring
follicle-stimulating hormone (FSH), an essential hormone to treat
infertility. GONAL-f® has been approved for use in the treatment of
infertility in Europe since 1995 and since 1997 in the United States,
and is available in more than 100 countries worldwide. It is the most
widely prescribed gonadotropin in the world. Not all indications are
approved in all markets for all product offerings.

Our Pens

Our pens consist of prefilled ready-to-use pens for GONAL-f® 300
IU, 450 IU, and 900 IU, and OVITRELLE®/OVIDREL® 250 mcg and
Pergoveris® 300IU, 450IU and 900IU. The pens were developed based on
feedback from healthcare professionals and those experiencing
fertility problems, in order to ease the teaching, learning and use
of the pens. Not all products are approved in all markets.

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About Merck

Merck is a leading science and technology company in healthcare,
life science and performance materials. Around 50,000 employees work
to further develop technologies that improve and enhance life - from
biopharmaceutical therapies to treat cancer or multiple sclerosis,
cutting-edge systems for scientific research and production, to
liquid crystals for smartphones and LCD televisions. In 2016, Merck
generated sales of EUR 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and
chemical company. The founding family remains the majority owner of
the publicly listed corporate group. Merck, Darmstadt, Germany holds
the global rights to the Merck name and brand. The only exceptions
are the United States and Canada, where the company operates as EMD
Serono, MilliporeSigma and EMD Performance Materials.

Contact: Dr. Raphaela Farrenkopf, [phone]

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ots Originaltext: Merck KGaA
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