European Commission Grants Approval for Merck's New Pergoveris(R) Pen for Fertility Treatment


European Commission Grants Approval for Merck's New Pergoveris(R) Pen for Fertility Treatment


DARMSTADT, Germany, May 10, 2017 /PRNewswire=KYODO JBN/--

    Not intended for U.S. and UK based media  

    With this approval, Pergoveris(R) becomes the first product with a

combination of FSH and LH hormones in a ready-to-use liquid version

The new pre-filled injection device for self-administration  increases

ease-of-use for patients compared to the vial form

Merck, a leading science and technology company, today announced that the

European Commission has granted approval for the new Pergoveris(R) Pen,

addressing an unmet medical need by providing an improved, convenient and

ready-to-use fertility combination treatment option for women with severe

follicle stimulating hormone (FSH) and luteinizing hormone (LH) deficiency.

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    "The European approval of our new Pergoveris(R)Pen is a step towards

fulfilling our commitment of improving treatment outcomes for couples aspiring

to become parents," said Luciano Rossetti, Global Head of Research and

Development at the biopharma business of Merck. "We strive for continual

innovation of our products for the benefit of our patients, and our new

Pergoveris(R) Pen enables us to provide women and couples with an improved

patient experience during their treatment journey."

    The new liquid version of Pergoveris(R) was created by evolving the

original freeze-dried powder and solvent combination - which required patients

to mix the product vials themselves before daily injection - towards a

ready-to-use pre-filled Pen solution. By eliminating the need for mixing, the

new Pergoveris(R) Pen allows an improved treatment experience for patients with

severe follicle stimulating FSH and LH deficiency.

    The new Pergoveris(R) Pen is the only premixed combination of human FSH

(hFSH) and human LH (hLH) on the European market available in a pre-filled

injection device for self-administration. Designed with feedback from patients

and healthcare professionals in mind, the Pergoveris(R) Pen enables physicians

to individualize the dosing to patient's needs, by allowing for 12.5 IU

increments and offering three strengths: 300IU, 450IU and 900IU. The

Pergoveris(R)Pen is the third addition to Merck's innovative delivery solution

Family of Pens(TM)

    About Pergoveris(R)  

    Pergoveris(R) is the first combined product of recombinant human follicle

stimulating hormone (r-hFSH or follitropin alfa 150 IU) and recombinant human

luteinizing hormone (r-hLH or lutropin alfa 75 IU). It is unique by combining

the benefits of two consistent and pure recombinant products, r-hFSH and r-hLH,

for the treatment of infertility in specific indications. Pergoveris(R) is

indicated for the stimulation of follicular development in adult women with

severe luteinizing hormone (LH) and follicle stimulating hormone (FSH)


    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 and

will include the Pergoveris(R) Pen 300IU, 450IU and 900IU once approved. The

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

professionals and those experiencing fertility problems to provide a common

injection solution 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 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. The company 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.

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