Merck Receives Positive CHMP Opinion for New Pergoveris® Fertility Pen

Darmstadt, Germany (ots/PRNewswire) -

Not intended for U.S. and UK based media

- Ready-to-use pre-filled pen provides a convenient treatment option
for patients
- Simplified injection device for self-administration comes in
multiple doses, addressing individual needs of patients

Merck, a leading science and technology company, today announced
that the European Committee for Medicinal Products for Human Use
(CHMP) has granted a positive opinion for the new Pergoveris® Pen.

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

(Logo: http://mma.prnewswire.com/media/471814/Pergoveris_Logo.jpg
)

"The combination of FSH and LH into a single formulation,
Pergoveris®, has proven to be a valued, unique innovation for
patients and the ART field since its first introduction," said Rehan
Verjee, Chief Marketing and Strategy Officer at the biopharma
business of Merck. "This new Pen adds to that heritage, demonstrating
our commitment to continuously improving our therapeutic and
technologies offering, based on feedback from healthcare
professionals and patients that we serve."

The new Pen is comprised of a ready-to-use liquid version of
Pergoveris® evolved from a freeze-dried powder and solvent
combination, available in vials, that required patients to mix the
product themselves before injection. By eliminating the need for
mixing, the new Pergoveris® Pen provides an improved, convenient and
easy-to-use treatment option for patients with severe follicle
stimulating hormone (FSH) and luteinizing hormone (LH) deficiency.
The liquid product will be the only premixed combination of
recombinant human FSH and human LH on the market available in a
pre-filled injection device for self-administration.

The new Pergoveris® Pen is the third addition to Merck's
innovative delivery solution Family of Pens(TM). The simple injection
device with improved ease-of-use helps patients feel confident in
administering their treatment, knowing they are using the correct
product mix and dose. The Pergoveris® Pen enables a fine-tuning of
treatment allowing for 12.5 IU increments and will be available in
three strengths: 300IU, 450IU and 900IU. It enables healthcare
professionals to precisely target the dosing to patients' needs.

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 2015, Merck
generated sales of EUR 12.85 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.

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ots Originaltext: Merck KGaA
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