ATIR Classified as "Cell Based" Medicinal Product by the EMEA



    A Classification for Innovative New Treatments

    AMSTERDAM, Dec. 14 /CNW/ - Kiadis Pharma announced today that its lead
product ATIR has received approval for regulatory classification as a "cell
based" medicinal product by the Innovation Task Force (ITF), a division of the
European Medicines Agency (EMEA). Based upon this regulatory classification
ATIR is eligible for EMEA procedures. As a next step Kiadis Pharma will file
for orphan drug designation with the EMEA to obtain additional product
protection upon marketing approval. In November this year ATIR has been
granted orphan drug designation by the US Food and Drug Administration (FDA).
    ATIR is under development to prevent acute Graft versus Host Disease
(GvHD) allowing the use of a mismatched donor for bone marrow
transplantations. It's a personalized cell-based treatment prepared according
to a proprietary protocol using both a novel small molecule substance and a
proprietary medical device. With the official classification of ATIR as a cell
based medicinal product by the EMEA, it's now categorized as an Advanced
Therapy and considered to be a highly innovative treatment. The benefits are a
centralized marketing authorization procedure, which harmonizes and
facilitates access to the European market. In addition, it provides access to
an expert Committee for Advanced Therapies within the EMEA, to address
scientific, legal and regulatory issues during product development.
    "We are very pleased having received a cell based medicinal product
classification for ATIR. The regulatory guidelines that will rule ATIR are
therefore clear and we have subsequently started with the application of the
orphan drug designation with the EMEA which will be filed before the end of
this year", said Manja Bouman, CEO Kiadis Pharma.

    About ATIR

    ATIR is designed to prevent life-threatening acute GvHD by eliminating
the immune cells from the donor graft that otherwise attack the patient's
body. Useful donor immune cells that can fight infections and remaining tumor
cells are, however, spared, allowing rapid and safe donor immune
reconstitution post transplantation. Acute GvHD is a major complication of
allogeneic bone marrow transplantations. By preventing the occurrence of acute
GvHD, ATIR enables the use of a mismatched donor and consequently addresses a
significant limitation in bone marrow transplantation, the timely availability
of a donor. Moreover, it could improve the general outcome of bone marrow
transplants.





For further information:

For further information: Kiadis Pharma, Eefje Simpelaar,
e.simpelaar@kiadis.com, +31-20-888-4815, +31-61-082-9344

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KIADIS PHARMA B.V.

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