EMD Serono Establishes Immuno-Oncology Research and Early Development Platform to Advance Innovation in Cancer Therapies

  EMD Serono Establishes Immuno-Oncology Research and Early Development
  Platform to Advance Innovation in Cancer Therapies

  *New innovation platform for developing therapies that stimulate a
    patient’s immune system to fight cancer
  *Goal is to develop immunotherapies that work in combination with other
    therapeutic modalities to maximize patient outcomes
  *Platform uniquely integrates research, early stage development and
    biomarker strategies to advance investigational immunotherapies

Business Wire

ROCKLAND, Mass. -- June 26, 2013

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced
today its commitment to the field of cancer immunotherapy by creating a fully
dedicated immuno-oncology innovation platform integrating research, early
development and biomarker strategies. In addition to the company’s existing
oncology platform, this new immuno-oncology platform will focus on developing
therapies that leverage the immune system’s natural ability to fight tumors,
and work in combination with existing and future therapies.

“We are pleased to announce our commitment to immuno-oncology, recognizing
that the complexity of cancer requires diverse approaches that will enable
alternative therapeutic interventions,” said Bernhard Kirschbaum, Head of
Global Research and Early Development at Merck Serono, a division of Merck
KGaA, Darmstadt, Germany. “In order to spur research and early development in
this specialized area, we have created an innovative environment where
researchers and clinicians work side-by-side to advance potential new cancer
immunotherapies.”

The new immuno-oncology platform includes three innovation clusters, each of
which is focused on discovery research and the advancement of molecules into
the clinic through proof of confidence:

  *Therapeutic cancer vaccines: targeting tumor antigens to elicit a
    tumor-specific immune response
  *Cancer stem cells: targeting cancer stem cells to prevent or reduce tumor
    formation and inhibit metastases
  *Immunotolerance: eliminating or circumventing inhibitory mechanisms in the
    immune system that prevent cancer cells from being recognized and attacked
    by the body

To ensure a broad immuno-oncology research and early development platform, EMD
Serono has assembled an in-house team of preeminent researchers and clinicians
who will focus resources and technologies to build a portfolio of
investigational immunotherapies, while collaborating with premier academia,
research and industry organizations to complement internal capabilities.

The current immuno-oncology portfolio comprises therapeutic candidates in
early clinical development and a robust pipeline of pre-clinical molecules.
Leading therapeutic concepts in the clinic are:

  *A monoclonal antibody targeting PD-L1 (programmed cell death ligand)
    expressed by various tumors, currently in Phase I in solid tumors
  *NHS-IL12, a cancer immunotherapy targeting IL-12 to the necrotic regions
    of tumors, sponsored by the United States National Cancer Institute (NCI),
    currently in Phase I in solid tumors
  *NHS-IL2, targeting IL-2 to the necrotic regions of tumors, completed Phase
    I and currently preparing for Phase II in solid tumors

“Our goal is to develop leading immunotherapies that work in combination with
other therapeutic modalities, understanding that attacking multiple cancer
targets simultaneously increases the possibility of therapeutic success,” said
Helen Sabzevari, Head of Immuno-Oncology, Global Research and Early
Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “We
are committed to delivering on the promise of immuno-oncology by combining
creative thinking with strong research and clinical excellence, and, more
importantly, by keeping patient needs at the heart of our efforts.”

For more information about EMD Serono’s immuno-oncology (iONC) platform,
please visit ionc.emdserono.com.

Disclaimer

Clinical candidates are currently under clinical investigation and have not
been approved for use in the U.S., Europe, Canada, or elsewhere. These
candidates have not been proven to be either safe or effective and any claims
of safety and effectiveness can be made only after regulatory review of the
data and approval of the labeled claims.

About EMD Serono, Inc.

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader
in the US biopharmaceutical arena, integrating cutting-edge science with
unparalleled patient support systems to improve people's lives. The company
has strong market positions in neurodegenerative diseases, endocrinology and
in reproductive health. In addition, EMD Serono is growing its expertise and
presence in the area of oncology, with more than 15 projects currently in
development. With a clear focus on the patient and a leadership presence in
the biopharmaceutical industry, EMD Serono’s US footprint continues to grow,
with approximately 1,000 employees around the country and fully integrated
commercial, clinical and research operations in the company’s home state of
Massachusetts.
For more information, please visit www.emdserono.com.

About Merck KGaA

Merck is a leading pharmaceutical, chemical and life science company with
total revenues of € 11.2 billion in 2012, a history that began in 1668, and a
future shaped by approx. 38,000 employees in 66 countries. Its success is
characterized by innovations from entrepreneurial employees. Merck's operating
activities come under the umbrella of Merck KGaA, in which the Merck family
holds an approximately 70% interest and free shareholders own the remaining
approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated
and has been an independent company ever since.

Contact:

EMD Serono
Erin-Marie Beals, 781-681-2850