Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

Tokyo (ots/PRNewswire) -

- Poteligeo has been approved for the treatment of the two most
common types of Cutaneous T-cell lymphoma (CTCL) in previously
treated patients based on data showing improved
progression-free survival (PFS) and overall response rate (ORR)
when compared to vorinostat.

- FDA approval was based on MAVORIC, the largest randomized study
conducted in patients with mycosis fungoides (MF) and Sézary
syndrome (SS), subtypes of CTCL, and the first pivotal trial in
CTCL to use PFS as a primary endpoint.

- Poteligeo is the first biologic agent targeting CCR4 to be
available for patients in the U.S.

Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that
the U.S. Food and Drug Administration (FDA) has granted approval for
Poteligeo® (mogamulizumab-kpkc) for the treatment of adult patients
with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome
(SS) after at least one prior systemic therapy. FDA granted Priority
Review and Breakthrough Therapy Designation in late 2017.

Poteligeo is a humanized monoclonal antibody (mAb) directed
against CC chemokine receptor 4 (CCR4), which is frequently expressed
on leukemic cells of certain blood cancers including CTCL. Using the
proprietary POTELLIGENT® technology, the amount of fucose in the
sugar chain structure of Poteligeo is reduced, which enhances the
antibody dependent cellular cytotoxicity (ADCC).

"I believe the approval is very good news for patients who have
been suffering from mycosis fungoides (MF) or Sézary syndrome (SS) in
the US," said Mitsuo Satoh Ph.D., Executive Officer, Vice President
Head of R&D Division of Kyowa Hakko Kirin. "Since this antibody was
discovered through our cutting-edge R&D activity, it is also another
important achievement for Kyowa Hakko Kirin in leaping forward to
become a global specialty pharmaceutical company."

"Mycosis fungoides (MF) and Sézary syndrome (SS) can be
disfiguring, and debilitating. MAVORIC, the largest study of systemic
therapy ever conducted in MF and SS, showed that mogamulizumab
prolonged progression-free survival compared to vorinostat in
patients with relapsed or refractory MF or SS," said Jeffrey S.
Humphrey, MD, President of Kyowa Kirin Pharmaceutical Development,
Inc.. "We look forward to the publication of MAVORIC's primary
results and to ongoing scientific exchange within the medical and
academic communities."

Because CTCL manifests itself in skin lesions, it is often
mistaken for other non-critical skin conditions, which can delay
conclusive diagnosis and treatment options. MF and SS are the two
most common subtypes of CTCL. MF is the most common subtype,
accounting for 50-70% of cases. It is a slow progressing form of
lymphoma that can involve the skin, blood, lymph nodes and organs,
and may be associated with severe infections. SS accounts for
approximately 3% of CTCL cases and is a more aggressive, leukemic
form of CTCL.

The FDA approval of Poteligeo is supported by the MAVORIC
(Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study,
which is the largest randomized trial in MF and SS and the first
pivotal trial in CTCL to use PFS as a primary endpoint. MAVORIC was a
Phase 3 open-label, multi-center, randomized study of mogamulizumab
versus vorinostat in patients with MF and SS who have failed at least
one prior systemic treatment. The study was conducted in the U.S.,
Europe, Japan and Australia, and randomized a total of 372 patients
to mogamulizumab or vorinostat. The results showed that mogamulizumab
demonstrated significantly superior PFS at a median of 7.6 months
[95% CI: 5.6, 10.2] compared to 3.1 months with vorinostat [95% CI:
2.8, 4.0], [hazard ratio 0.53: 95% CI: 0.41, 0.69; p<0.001]. The
confirmed overall response rate for mogamulizumab and vorinostat was
28% and 5%, respectively (p<0.001).

FDA granted Poteligeo Breakthrough Therapy Designation for the
treatment of MF and SS in adult patients, and evaluated Poteligeo
with Priority Review, which is reserved for drugs that treat a
serious condition and, if approved, would provide a significant
improvement in treatment safety or effectiveness.

Kyowa Kirin International PLC, a Kyowa Hakko Kirin Group company,
will be responsible for commercializing Poteligeo in the U.S. and
this is planned to commence in the fourth quarter of 2018. A
Marketing Authorization application for mogamulizumab is currently
under review by the European Medicines Agency.

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.

Please see Poteligeo indication and Important Safety Information
below.

INDICATION

POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion
is indicated for the treatment of adult patients with relapsed or
refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at
least one prior systemic therapy.

Important Safety Information

Warnings and Precautions:

- Dermatologic toxicity: Monitor patients for rash throughout the
course of treatment. For patients who experienced dermatologic
toxicity in the pivotal trial the median time to onset was 15
weeks, with 25% of cases occurring after 31 weeks. Interrupt
POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently
discontinue POTELIGEO for life-threatening (Grade 4) rash or for
any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis
(TEN).

- Infusion reactions: Most infusion reactions occur during or shortly
after the first infusion. Infusion reactions can also occur with
subsequent infusions. Monitor patients closely for signs and
symptoms of infusion reactions and interrupt the infusion for any
grade reaction and treat promptly. Permanently discontinue
POTELIGEO for any life-threatening (Grade 4) infusion reaction.

- Infections: Monitor patients for signs and symptoms of infection
and treat promptly.

- Autoimmune complications: Interrupt or permanently discontinue
POTELIGEO as appropriate for suspected immune-mediated adverse
reactions. Consider the benefit/risk of POTELIGEO in patients with
a history of autoimmune disease.

- Complications of allogeneic HSCT after POTELIGEO: Increased risks
of transplant complications have been reported in patients who
received allogeneic HSCT after POTELIGEO. Follow patients closely
for early evidence of transplant-related complications.

Adverse Reactions:

- The most common adverse reactions (reported in >= 10% of patients)
with POTELIGEO in the clinical trial were rash, including drug
eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea
(28%), drug eruption (24%), upper respiratory tract infection
(22%), musculoskeletal pain (22%), skin infection (19%), pyrexia
(17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia
(14%), constipation (13%), anemia (12%), mucositis (12%), cough
(11%), and hypertension (10%).

You are encouraged to report suspected adverse reactions to Kyowa
Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or
http://www.fda.gov/medwatch.

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 realize 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 humanized monoclonal antibody (mAb) directed
against CC chemokine receptor 4 (CCR4), which is frequently expressed
on leukemic cells of certain hematologic 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).

In August 2017, the FDA granted POTELIGEO Breakthrough Therapy
Designation status for the treatment of MF and SS in adult patients
who have received at least one prior systemic therapy. In November
2017, the FDA accepted the BLA for filing and granted POTELIGEO
Priority Review. POTELIGEO received FDA approval in August 2018.

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 characterized by localization of
malignant T lymphocytes to the skin, and depending on the stage, the
disease may involve skin, blood, lymph nodes, and viscera.

ots Originaltext: Kyowa Kirin
Im Internet recherchierbar: http://www.presseportal.de

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
Yvette Venable
Kyowa Kirin International PLC
+1 908-375-2358
Or +44 7388 222 769
Email: Yvette.Venable@kyowakirin.com

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