Merck Set to Launch New Version of Fertility Pens

PR63218

DARMSTADT, Germany, Feb. 3 /PRNewswire=KYODO JBN/ --

    Not intended for UK and U.S. based media

    - The Fertility Leader Merck receives market authorization from EMA for its

advanced GONAL-f(R) prefilled pen for improved ease-of-use

    - Patients, nurses and doctors help to innovate and improve the design of a

product which has already helped bring over two million babies into the world[1]

    Merck, a leading science and technology company, today received European

approval for the GONAL-f(R) prefilled pen 2.0 from the European Medicines

Agency. Originally launched in 2011, the new version of the pen includes

various advanced features, designed to bring an increased level of confidence

to patients during their fertility treatment.

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    "Similarly to the development of the previous version of the prefilled

pens, we listened to our patients and healthcare professionals, understanding

that the best insights come from the people using and working with our

fertility treatment portfolio. Being the world leader in fertility treatment,

we were carefully assessing their needs, using our knowledge gained from

working with the community for many decades to identify new solutions," said

Luciano Rossetti, Head of Global Research and Development, at the biopharma

business of Merck. "The new GONAL-f(R) prefilled pen was developed with a focus

on improving the patient treatment experience using the pen. This ensures that

the pen is simple to handle so that patients feel confident they are getting

the highest possible chance to become pregnant."

    Since its launch 20 years ago, more than two million babies have been

brought to the world with the help of GONAL-f(R)[1]. The prefilled pen provides

patients with a simplified self-administrating injection platform for Merck's

gonadotropins. Its enhanced design has made the new GONAL-f(R) prefilled pen

easier to handle with a larger display window that improves the readability of

the dosage information. Together with a graduated scale on a transparent

cartridge, these new features provide increased clarity for the patient,

reassuring them that the correct preset dose has been administered.[2] These

enhanced qualities add to the strong original key features of the prefilled

pen: dosing accuracy[3],[4] and the ability to improve treatment outcomes by

enabling individualized dosing.[5]

    With a high need for specialized and innovative solutions, patients

suffering from infertility is one of Merck's core focus areas in healthcare.

The new GONAL-f(R) prefilled pen is the most recent addition to our growing

portfolio to support fertility treatment. Using its long heritage and in-depth

knowledge in the area, Merck continues to drive innovation to help further

improve fertility treatment outcomes.

    References

    1. Market Data Analytics

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

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

    3. Christen, M. et al. Expert Opin Drug Deliv. 2011;8(6):833-839

    4. Schertz, J.C. et al. Expert Opin Drug Deliv. 2011;8(9):1111-1120

    5. Popovic-Todorovic, B. et al. Human Reproduction. 2003;18(11):2275-2282

    About GONAL-f(R)

    GONAL-f(R) (follitropin alfa) is a recombinant human follicle-stimulating

hormone (r-hFSH) approved for the treatment of both male and female

infertility. It is prescribed to supplement or replace naturally occurring

follicle-stimulating hormone (FSH), an essential hormone to treat infertility

in both women and men. 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.

    The Family of Pens(TM)

    The Family of Pens(TM) consists of prefilled ready-to-use pens for

GONAL-f(R) 300 IU, 450 IU, and 900 IU, and OVITRELLE(R)/OVIDREL(R) 250 mcg. The

Family of Pens(TM) was developed based on feedback from healthcare

professionals and those experiencing fertility problems to provide a common

injection platform for Merck's gonadotropins, in order to ease the teaching,

learning and use of the pens.

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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 2014, Merck generated sales of EUR 11.3 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.

    Your Contact: Bettina Frank +49-6151-72-4660

SOURCE: Merck KGaA