Kyowa Kirin Announces POTELIGEO® Receives Marketing Authorisation inEurope for the Treatment of Mycosis Fungoides and Sézary Syndrome

Tokyo (ots/PRNewswire) – POTELIGEO will be the first biologic agent
targeting CCR4 to be available for patients in Europe.

Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that it
has received a European Commission decision granting a marketing
authorisation to POTELIGEO® (Generic name: mogamulizumab), a
humanised monoclonal antibody (mAb) directed against CC chemokine
receptor 4 (CCR4), for the treatment of adult patients with mycosis
fungoides (MF) or Sézary syndrome (SS) who have received at least one
prior systemic therapy.

MF and SS are the two most common subtypes of cutaneous T-cell
lymphoma (CTCL), a rare type of non-Hodgkin’s lymphoma.

The European Medicines Agency (EMA)’s Committee for Medicinal
Products for Human Use (CHMP), adopted a Positive Opinion
recommending approval of the marketing authorisation for POTELIGEO in
September 2018.

The European Marketing Authorisation is valid in the 28 countries of
the European Union and in Norway, Iceland and Liechtenstein. Kyowa
Kirin plans to launch POTELIGEO in various markets in Europe from
2019. Kyowa Kirin International PLC, a Kyowa Hakko Kirin Group
company, is responsible for commercialising POTELIGEO in Europe.

„With this approval, now there is a new option for the patients with
mycosis fungoides (MF) or Sézary syndrome (SS) across Europe,“ said
Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D
Division of Kyowa Kirin. „I’m delighted about the European
Commission’s decision which is strategically important for us to
realise our mid-term business plan and our goal as a global specialty
pharmaceutical company.“

Tom Stratford, CEO of Kyowa Kirin International, said: „Mycosis
fungoides (MF) and Sézary syndrome (SS) are horrible conditions which
patients literally wear on their skin. The granting of this marketing
authorisation is encouraging news for those across Europe who live
with these conditions every day and we look forward to making
POTELIGEO available for patients and clinicians across Europe.“

„POTELIGEO offers a new approach to tackling the underlying disease
pathophysiology of mycosis fungoides (MF) and Sézary syndrome (SS).
By targeting CCR4-expressing T cells in blood and skin we could have
a new option to manage patient symptoms.“ Said Professor Martine
Bagot, Head of the Department Dermatology in Hospital Saint Louis,
Paris.

The Kyowa Hakko Kirin Group companies strive to contribute to the
health and well-being of people around the world by creating new
value through the pursuit of advances in life sciences and
technologies.

About Kyowa Kirin

Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences
company, with special strengths in biotechnologies. In the core
therapeutic areas of oncology, nephrology and immunology/allergy,
Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on
antibody technologies, to continually discover innovative new drugs
and to develop and market those drugs world-wide. In this way, the
company is working to realise its vision of becoming a Japan-based
global specialty pharmaceutical company that contributes to the
health and wellbeing of people around the world.

Kyowa Kirin International PLC is a wholly owned subsidiary of Kyowa
Hakko Kirin and is a rapidly growing specialty pharmaceutical company
engaged in the development and commercialization of prescription
medicines for the treatment of unmet therapeutic needs in Europe and
the United States. Kyowa Kirin International is headquartered in
Scotland.

You can learn more about the business at: http://www.kyowa-kirin.com

About POTELIGEO

POTELIGEO is a humanised monoclonal antibody (mAb) directed against
CC chemokine receptor 4 (CCR4), which is frequently expressed on
leukaemic cells of certain haematologic malignancies including CTCL
(cutaneous T-cell lymphoma). POTELIGEO was produced using Kyowa Hakko
Kirin’s proprietary POTELLIGENT® platform, which is associated with
enhanced antibody-dependent cellular cytotoxicity (ADCC).

About Mycosis Fungoides (MF) and Sézary Syndrome (SS)

MF and SS are the two most common subtypes of CTCL, a rare type of
non-Hodgkin’s lymphoma, which is characterised by CCR4 related
localisation of malignant T lymphocytes to the skin, and depending on
the stage, the disease may involve skin, blood, lymph nodes, and
viscera.

Digital press kit: http://www.ots.at/pressemappe/PR132936/aom

Contact:
media@kyowa-kirin.co.jp
Callum Spreng
Spreng Thomson Ltd. (For Kyowa Kirin International PLC)
+44(0)141-548-5191
Mobile: +44(0)7803-970103
Email: callum@sprengthomson.com

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