Merck 2014 Annual Report Download - page 77

72 GROUP MANAGEMENT REPORT → FUNDAMENTAL INFORMATION ABOUT THE GROUP → Research and development at the group
Neurology
The Biopharmaceuticals division and the Institute of Experimental
Neurology at San Raffaele University and Research Hospital in
Milan announced the continuation of a strategic alliance to
develop pre-clinical and clinical research projects in the field of
neurodegenerative diseases. The translational research will focus
on developing innovative therapies against serious and disabling
neurological diseases affecting young adults in particular, such as
multiple sclerosis (MS). Established in 2004, the renewal of this
partnership extends the agreement between the parties for two
additional years.
Following completion of a Phase I clinical study that demon-
strated encouraging MRI results following intradermal treatment
of patients with relapsing multiple sclerosis (RMS) with ATX-
MS-1467, an investigational immune-tolerizing agent, a Phase II
study has been initiated in RMS.
Following a thorough portfolio review, the Biopharmaceu-
ticals division decided not to pursue further development of plo-
vamer acetate, an investigational second-generation copolymer
for relapsing-remitting MS. As a consequence, the Phase II study
was terminated early. Merck KGaA, Darmstadt, Germany, and
Ono Pharmaceutical reached a mutual agreement to terminate the
license agreement on ceralifimod (ONO-4641) since the project did
not meet the company’s threshold for continued investment.
The Biopharmaceuticals division remains committed to driv-
ing innovation in the field of MS and improving the lives of people
living with the disease. In refocusing the pipeline, additional
resources will be available to strengthen our pipeline in this area
and bring additional, meaningful products and devices to people
with MS.
Fertility
In the field of Fertility, a PhaseIII trial of Pergoveris® was initiated
in the first quarter of 2014 and enrollment was already completed,
following the inclusion of 946 patients, in the third quarter. The
trial, which is known as
ESPART® (Evaluating the Efficacy and
Safety of Pergoveris® in ART), is a multicenter, randomized,
controlled, single-blind trial with the primary endpoint being the
total number of retrieved oocytes. The study is designed to assess
the efficacy and safety of Pergoveris® (follitropin alfa and lutropin
alfa) versus Gonal-f® (follitropin alfa) for multifollicular develop-
ment as part of an Assisted Reproductive Technology (ART)
treatment cycle in women who are classified as poor ovarian
responders (POR) to previous ART. Data are expected in 2015.
Endocrinology
In the field of Endocrinology, the Biopharmaceuticals division an-
nounced in April that the PhaseIIIb study of Kuvan® (sapropterin
dihydrochloride) had met its primary endpoint. At the Society for
the Study of Inborn Errors of Metabolism (SSIEM) Annual Sympo-
sium in Innsbruck in early September, detailed 26-week data from
the study known as
SPARK (Safety Pediatric EfficAcy PhaRmaco-
kinetic with Kuvan®) were presented. Results from the study showed
that the addition of Kuvan® at a dose of 10 or 20mg / kg / day to a
phenylalanine-restricted diet significantly increased phenylala-
nine tolerance in children with phenylketonuria (PKU) who are
below four years of age and responsive to Kuvan®, compared with
patients on diet alone. The
SPARK study was requested by the
EMA as a post-authorization measure. Given the positive outcome
of the study, the Biopharmaceuticals division has submitted an
application to the EMA for a label extension.