Merck Announces Initiation of Phase III Fertility Study with Pergoveris in Poor Ovarian Response Patients

Darmstadt, Germany (ots/PRNewswire) -

- The ESPART* Phase III clinical study focuses on patients that respond
poorly to attempts at ovarian stimulation
- Study aims to recruit 946 patients across 17 European countries

Merck, the global pharmaceutical and chemical company, today
announced the enrollment of the first patient into a new Phase III
study in the area of fertility, marking another step in its efforts
to explore innovative solutions in areas of unmet medical need.

The ESPART* study is designed to assess the efficacy and safety of
Pergoveris(R) (follitropin alfa and lutropin alfa) versus GONAL-f(R)
(follitropin alfa) for multifollicular development as part of an
Assisted Reproductive Technology (ART) treatment cycle in women who
are classified as poor ovarian responders (POR). Generally, in such
patients, a low number of follicles develop during treatment, and, as
a consequence, a small number of oocytes are retrieved through ART.
The study aims to recruit 946 patients across 17 European countries.
Pergoveris is a fixed combination of recombinant human follicle
stimulating hormone (r-hFSH) and recombinant human luteinizing
hormone (r-hLH) delivered via subcutaneous injection.

"The ESPART study is part of our ongoing commitment to working
with fertility specialists to achieve the shared goal of increasing
pregnancy rates and addressing the challenges that patients face in
order to help them overcome the barriers to fertility," said John
Orloff, Head of Clinical Development of Merck Serono, the
biopharmaceutical division of Merck. "As a leader in reproductive
health we hope that it will help us understand how to better address
the challenges faced by women with poor ovarian response."

Merck has committed itself to finding innovative solutions to
develop the next generation of fertility treatments. More than 72.4
million people are affected by infertility worldwide[1] and,
according to the World Health Organization (WHO),[2] 15 percent of
couples of childbearing age seek medical help for infertility.
Infertility is one of the main focus areas and an important growth
driver for Merck's largest division.

"A current trend in society is for women to delay pregnancy until
later in their life and, as a consequence, women may face lower
chances of pregnancy due to the reduced quantity and quality of
oocytes in their ovaries, thus new treatment options are needed in
fertility to maximize the chances of success," said Professor Peter
Humaidan, Aarhus University, Skive, Denmark, principal investigator
of ESPART. "With the ESPART study we hope to gain clarity if poor
ovarian responders would benefit from the addition of recombinant LH
in the protocols of stimulation, to ultimately achieve higher
pregnancy rates."

The ESPART Phase III multicenter, randomized, controlled,
single-blind trial compares Pergoveris versus GONAL-f in patients who
are classified as POR, as aligned with the outcomes of the 2011
Consensus Meeting of the European Society of Human Reproduction and
Embryology (ESHRE).[3] The primary endpoint of the ESPART study is
total number of retrieved oocytes. Secondary endpoints include
ongoing pregnancy rate, live birth rate, embryo implantation rate,
clinical pregnancy rate and biochemical pregnancy rate. The design of
this trial is supported by the outcomes of a meta-analysis published
last month by Lehert and colleagues in the journal Reproductive
Biology and Endocrinology.[4] This analysis suggests that the
combination of r-hFSH plus r-hLH during ovarian stimulation might
offer a benefit to a certain subgroup of patients who are classified
as POR.

The Lehert meta-analysis reviewed data from 43 randomized
controlled trials, investigating 6443 patients. The results of this
meta-analysis showed no significant differences in the number of
oocytes retrieved for the overall patient population, between the
r-hFSH plus r-hLH and r-hFSH groups (weighted mean difference -0.03;
95% confidence interval [CI] -0.41 to 0.34). However, in POR patients
treated with r-hFSH plus r-hLH, significantly more oocytes were
retrieved than with r-hFSH alone (n = 1077; weighted mean difference
+0.75 oocytes; 95% CI 0.14-1.36). Additionally, a significantly
higher clinical pregnancy rate was observed with r-hFSH plus r-hLH
versus r-hFSH alone, not only in the overall patient population
analysed (risk ratio [RR] 1.09; 95% CI 1.01-1.18) but also in POR
patients, where these differences were even more pronounced (n =
1179; RR 1.30; 95% CI 1.01-1.67; ITT population).[4]

*ESPART: Evaluating the Efficacy and Safety of Pergoveris(R) in
ART

About Pergoveris

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

The ESPART study is a Phase III multicenter, randomized,
controlled, single-blind, parallel arm trial, designed to assess the
efficacy and safety of Pergoveris versus GONAL-f(R) (follitropin
alfa) for multifollicular development as part of an ART treatment
cycle in patients who are poor ovarian responders, aligned with the
European Society of Human Reproduction and Embryology (ESHRE)
criteria. The study's primary endpoint is total number of retrieved
oocytes.

About GONAL-f

GONAL-f(R) a recombinant human follicle stimulating hormone,
r-hFSH, follitropin alfa, is used to substitute or enhance low or
lacking naturally occurring FSH causing female and male infertility.
GONAL-f pens are filled by mass (FbM), which ensures consistency in
the FSH dosage.

References

[1] Boivin et al., International estimates of infertility
prevalence and treatment-seeking: potential need and demand for
infertility medical care, Human Reproduction Vol.22, No.6 pp.
1506-1512, 2007 doi:10.1093/humrep/dem046

[2] WHO Scientific Group, Recent advances in medically assisted
conception: report of a WHO scientific group. WHO Technical Report
Series, No. 820. Geneva, World Health Organization, 1992

[3] Ferraretti et al., ESHRE consensus on the definition of 'poor
response' to ovarian stimulation for in vitro fertilization: the
Bologna criteria; Human Reproduction, 2011; 26(7): 1616-1624

[4] Lehert et al., Recombinant human follicle-stimulating hormone
(r-hFSH) plus recombinant luteinizing hormone versus r-hFSH alone for
ovarian stimulation during assisted reproductive technology:
systematic review and meta-analysis. Reproductive Biology and
Endocrinology; 2014 Feb 20;12(1):17

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Merck is a leading company for innovative and top-quality
high-tech products in the pharmaceutical and chemical sectors. With
its four divisions Merck Serono, Consumer Health, Performance
Materials and Merck Millipore, Merck generated total revenues of EUR
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countries to improve the quality of life for patients, to further the
success of customers and to help meet global challenges. Merck is the
world's oldest pharmaceutical and chemical company - since 1668, the
company has stood for innovation, business success and responsible
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