European Commission Grants Approval for Merck's New Pergoveris® Pen for Fertility Treatment

Darmstadt, Germany (ots/PRNewswire) -

Not intended for U.S. and UK based media

- With this approval, Pergoveris® 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® 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.

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

(Photo: http://mma.prnewswire.com/media/510209/Pergoveris.jpg )

"The European approval of our new Pergoveris® 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® Pen enables us to provide
women and couples with an improved patient experience during their
treatment journey."

The new liquid version of Pergoveris® 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® Pen allows an improved treatment
experience for patients with severe follicle stimulating FSH and LH
deficiency.

The new Pergoveris® 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® 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® Pen is the
third addition to Merck's innovative delivery solution Family of
Pens(TM).

About Pergoveris®

Pergoveris® 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® is indicated for the
stimulation of follicular development in adult women with severe
luteinizing hormone (LH) and follicle stimulating hormone (FSH)
deficiency.

The Family of Pens(TM)

The Family of Pens(TM) consists of prefilled ready-to-use pens for
GONAL-f® 300 IU, 450 IU, and 900 IU, and OVITRELLE®/OVIDREL® 250 mcg
and will include the Pergoveris® 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.

Your Contact: Dr. Raphaela Farrenkopf, +49-6151-72-2274

ots Originaltext: Merck KGaA
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Original-Content von: Merck KGaA, übermittelt durch news aktuell