Merck 2014 Annual Report Download - page 73

68 GROUP MANAGEMENT REPORT → FUNDAMENTAL INFORMATION ABOUT THE GROUP → Research and development at the group
With a forward-looking view, the global R&D organization of
the Biopharmaceuticals division is positioning itself for future
success. Strong collaboration, an unwavering commitment to
exceptional science and a focus on objective decision-making are
the key principles that will guide the R&D teams in 2015. As a
recent example, the Global Medical Affairs (GMA) organization
underwent a complete redesign and strategic refocusing in 2014.
Patient centricity was at the core of this effort which has several
cornerstones: enhancement of therapeutic area expertise in key
areas, a global best-practice sharing working style and the
establishment of a novel function known as medical excellence.
The new GMA organization was launched in August and imple-
mentation at headquarters, in regions and in countries worldwide
is progressing rapidly, and is on track for completion in early
2015. The new organization is already delivering enhanced value
to life cycle management of the Biopharmaceuticals division’s
registered products, as well as contributing significantly to the
late-stage development process.
At the Biopharmaceuticals division’s Investor & Analyst Day
in September, the company gave an update on its plans for its
Biosimilars activities. In addition to the already disclosed invest-
ment plan of €100 million for 2014, the unit plans to continue to
invest in 2015, depending on the outcome of ongoing Phase I
studies. Existing partnerships with India’s Dr. Reddy’s and Brazil’s
Bionovis will be expanded by another, as yet undisclosed in-
l icensing agreement for a late-stage biosimilar, initially for smaller
emerging markets. Between 2015 and 2016, Merck KGaA, Darm-
stadt, Germany, plans to initiate between two and five PhaseIII
clinical trials.
BIOPHARMACEUTICALS PIPELINE IN 2014
The Biopharmaceuticals division’s core R&D fields include oncol-
o
gy, immuno-oncology, immunology and neurology. The develop-
ment pipeline continues to be weighted towards oncology; how-
ever, 2014 saw important scientific and business development
advances in several disease areas. In line with its open collabora-
tive model in R&D, the Biopharmaceuticals division entered into a
number of collaborations during 2014, some of which are high-
lighted below.
In addition, the company announced the launch of the Bio-
pharmaceutical division's Global Grants with a total annual invest-
ment of over €20 million, thereby underscoring the company’s
commitment to funding scientific innovation and independent
medical education around the world. The Grants for Innovation in
Research identify and fund what are considered to be the most
promising research projects in specific fields worldwide, originat-
ing from across the biopharma spectrum, including: academia,
research centers, and smaller biotech companies. During the third
quarter, Grants for Innovation were awarded in the areas of Mul-
tiple Sclerosis, Oncology, Growth Disorders and Fertility.
Oncology
There were several important changes in the oncology pipeline
during 2014. Evofosfamide (also known as TH-302), an investiga-
tional hypoxia-activated prodrug which is being developed in
collaboration with Threshold Pharmaceuticals, is currently being
evaluated in two PhaseIII trials, respectively in locally advanced,
unresectable or metastatic soft tissue sarcoma (STS) and in
advanced pancreatic cancer. A pre-planned interim efficacy and
safety analysis of the STS study was performed in the third quarter
of 2014. The Independent Data Monitoring Committee (IDMC),
which conducted the analysis, recommended that the study should
continue as planned to its natural conclusion. The analysis of the
primary endpoint, overall survival (OS), is expected to be conducted
in 2016. This date is only an approximation since the final analy-
ses will be triggered only when a certain number of events have
occurred. The second PhaseIII study (known as MAESTRO), which
is being performed in advanced pancreatic cancer, reached
planned enrollment of 660 patients in October. It is estimated that
the final analysis of the primary endpoint of this trial, which is OS,
will be performed in 2016. A Phase II trial of evofosfamide in
combination with pemetrexed as a potential second-line treatment
for patients with advanced non-squamous non-small cell lung
cancer (NSCLC) was initiated in the second quarter of 2014. The
primary endpoint in this 440-patient trial is OS.