Miltenyi Biotec Receives FDA Approval for CliniMACS® CD34 Reagent System for Prevention of Graft-Versus-Host Disease in the Treatment of Acute Myeloid Leukemia

CAMBRIDGE, MA and BERGISCH GLADBACH, GERMANY (ots) -

CliniMACS® CD34 Reagent System approved as a Humanitarian Use Device
authorized by U.S. Federal law

Miltenyi Biotec announced today that the U.S. Food and Drug
Administration (FDA) has approved the company's CliniMACS CD34
Reagent System as a Humanitarian Use Device for the prevention of
graft- versus-host disease (GVHD) in patients with acute myeloid
leukemia (AML) in first complete remission undergoing allogeneic stem
cell transplantation (SCT) from a matched related donor.

The CliniMACS CD34 Reagent System decreases the risk of developing
GVHD, a life-threatening complication that can occur following an
allogeneic transplant, in which T cells from the donor attack various
tissues of the recipient. The FDA-approved device efficiently removes
donor T cells from the graft prior to transplantation by enriching
CD34+ blood stem cells, which go on to repopulate the patient's
immune and blood building systems.

"When chronic GVHD develops after stem cell transplantation, the
result is a substantial decrease in the patient's quality of life,"
said Stefan Miltenyi, president and founder of Miltenyi Biotec. "We
are very excited to be able to provide a new treatment option to
clinicians and their patients having to undergo a transplantation
procedure."

The FDA approval was based on data from a Phase II, single-arm,
multi-center study (BMT CTN 0303) conducted by the Blood and Marrow
Transplant Clinical Trials Network which is supported by The National
Heart, Lung, and Blood Institute and The National Cancer Institute of
The National Institutes of Health. The trial showed that following
intensive myeloablative conditioning, stem cell transplantation from
an identical sibling donor processed using the CliniMACS CD34 Reagent
System as the sole means of GVHD prophylaxis leads to a low incidence
of chronic GVHD (19 percent at two years after transplantation)
without negatively affecting relapse, engraftment, overall survival
or disease-free survival (Pasquini et al. (2012), JCO and Devine et
al. (2011), Biol Blood Marrow Transplant).

"The low incidence of acute and chronic GVHD, in the absence of
additional immunosuppression are distinct advantages in using the
CliniMACS CD34 Reagent System," said Dr. Robert J. Soiffer, Chief of
the Division Hematologic Malignancies at the Dana-Farber Cancer
Institute and investigator in the Blood and Marrow Transplant
Clinical Trials Network.

For more information regarding the availability of the CliniMACS
CD34 Reagent System and Miltenyi Biotec, visit
www.miltenyibiotec.com.

About Graft-Versus-Host Disease (GVHD)

Prevention of GVHD is a major unmet medical need in allogeneic
stem cell transplantation. It can occur following transplantation, as
the donor stem cells grow and repopulate the body's immune system.
Immune cells in the transplant, called T cells, may identify the
patient's body as foreign and attack tissues and organs. This attack
by donor T cells on the patient's tissues is called GVHD. GVHD may
cause serious damage to the liver, skin, mucosa, and gastrointestinal
tract. GVHD varies from mild to severe and can result in death.

About the CliniMACS CD34 Reagent System

The CliniMACS CD34 Reagent System is an in vitro medical device
system that uses antibodies conjugated to magnetic beads to select
and enrich for CD34+ blood stem cells from a donor graft prior to
transplantation, while removing other cells that can cause GVHD.

About Miltenyi Biotec

With more than 1,300 employees in 22 countries, Miltenyi Biotec is
a global therapy developer and provider of products and services that
advance biomedical research and cell therapy. For the last 25 years,
the company's innovative tools have supported research at every
level, from basic and translational research to clinical application.
This complete portfolio of products and solutions enables scientists
and clinicians to access, analyze, and utilize primary cells and
primary-derived cells. Areas of clinical focus include hematology,
graft engineering, immunotherapies, and apheresis.

Media Contact:
Marc Longpre
+1 415-318-4267
press@miltenyibiotec.de