Merck Receives FDA Approval for New GONAL-f(R) Prefilled Pen

PR71011

DARMSTADT, Germany, Nov. 13, 2017 /PRNewswire=KYODO JBN/ --

- 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(R) (follitropin alfa

injection) prefilled pen from the U.S. Food and Drug Administration (FDA).

Known as GONAL-f(R) 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(R) 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(R) is the only

gonadotropin that comes in prefilled, ready-to-use pen in the U.S.[3] The new

GONAL-f(R) 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(R) 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

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

Data on file. Market Data Analytics. September 2015

Data on file. IMS MIDAS database Q4 2016, May 2017

GONAL-f(R) prefilled pen, Instructions for use. EU product information for

GONAL-f(R) solution for injection in a prefilled pen. December 2015

*Revised Formulation Female

About GONAL-f(R)

GONAL-f(R) (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(R) 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(R) 300 IU, 450 IU,

and 900 IU, and OVITRELLE(R)/OVIDREL(R) 250 mcg and Pergoveris(R) 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.

All Merck Press Releases are distributed by e-mail at the same time they become

available on the Merck Website. Please go to

http://www.merckgroup.com/subscribe to register online, change your selection

or discontinue this service.

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 € 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, +49-6151-72-2274

     (Logo: http://photos.prnewswire.com/prnh/20160913/406891LOGO )

Source: Merck KgaA