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
DARMSTADT, Germany,
Feb. 24, 2017 /CNW/ - 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™. 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™
The Family of Pens™ 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™ 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 € 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.
SOURCE Merck