Shionogi to Present Clinical Data on Lusutrombopag at the International Liver Congress™ 2019 of the European Association for the Study of the Liver (EASL)

OSAKA, Japan & AMSTERDAM–(BUSINESS WIRE)–Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V.
(hereafter “Shionogi”), announced it will present four posters on
lusutrombopag, a once-daily, orally administered, small molecule
thrombopoietin (TPO) receptor agonist, at The International Liver
Congress™, the annual meeting of the European Association for the Study
of the Liver (EASL), to be held in Vienna, Austria, April 10-14, 2019.
Lusutrombopag was granted marketing authorisation by the European
Commission (EC) on February 18, 2019 for the treatment of severe
thrombocytopenia in adult patients with chronic liver disease (CLD)
undergoing invasive procedures. It has already been approved for use in
Japan¹ and the US where it is marketed under the brand name
Mulpleta^®2.

All poster presentations will be displayed in Reed Messe Wien Exhibition
& Congress Center Hall B on Saturday, April 13, 2019 from 9:00 am to
5:00 pm Central European Time (CET). The research will be presented in
the Cirrhosis and Complications poster area and will include the
following:

• Poster SAT 002: Lusutrombopag Is a Safe Treatment Option for
  Thrombocytopenia in Patients with Chronic Liver Disease Undergoing an
  Invasive Procedure: Pooled Safety Analysis from 3 Studies

  Presenter:
  Nezam Afdhal

• Poster SAT 003: Real-World Data Demonstrate Safety and Effectiveness
  of Lusutrombopag in Chronic Liver Disease Patients with
  Thrombocytopenia Undergoing Planned Invasive Procedures: Interim
  Analysis

  Presenter: Nezam Afdhal

• Poster SAT 006: Efficacy of Oral Thrombopoietin Receptor Agonist
  Lusutrombopag in Chronic Liver Disease by Underlying Disease Aetiology

  Presenter:
  Naim Alkhouri

• Poster SAT 038: Lusutrombopag for Treatment of Thrombocytopenia in
  Patients with Chronic Liver Disease Who Are Undergoing Planned
  Invasive Procedures: Pooled Safety Analysis of Bleeding-Related
  Adverse Events

  Presenter: Edoardo G. Giannini

About Thrombocytopenia in Chronic Liver Disease
Thrombocytopenia
is defined as a platelet count of less than 150,000/µL. CLD-associated
thrombocytopenia may be caused by multiple factors including splenic
sequestration and decreased production of TPO. It is the most common
hematologic complication of CLD^3,4,5, with studies suggesting
that it occurs in up to 78% of patients with cirrhosis.⁶ Severe
thrombocytopenia (platelet count of less than 50,000/µL) is less common,
occurring in up to 11% of patients.⁷ Patients with CLD and
thrombocytopenia are at increased risk for bleeding, requiring recurrent
platelet transfusions, increased ambulatory visits and inpatient
hospital stays compared with patients with CLD without thrombocytopenia.^7,8 There
is evidence that the annual health care cost of a CLD patient with
thrombocytopenia is more than three times that of a CLD patient without
thrombocytopenia.⁸ In addition to the potential of
thrombocytopenia, especially severe thrombocytopenia (platelet count
less than 50,000/µL), which increase surgical or traumatic bleeding, it
may also significantly complicate routine diagnostic procedures and
patient care, such as liver biopsy and medically indicated or scheduled
procedures for cirrhotic patients, resulting in delayed or cancelled
curative treatment.⁹

About lusutrombopag
Lusutrombopag is a once-daily, orally
administered, small molecule TPO receptor agonist that triggers the
production of endogenous platelets by interacting with the transmembrane
domain of human TPO receptors expressed on megakaryocytes to induce the
proliferation and differentiation of megakaryocytic progenitor cells
from hematopoietic stem cells and megakaryocyte maturation.

On February 18, 2019, lusutrombopag received marketing authorisation by
the EC for the treatment of severe thrombocytopenia in adult patients
with CLD undergoing invasive procedures. Prior to this, lusutrombopag
was approved by the Ministry of Health, Labour and Welfare in Japan in
September 2015 for the improvement of thrombocytopenia associated with
CLD in patients undergoing an elective invasive procedure, and by the
U.S. Food and Drug Administration (FDA) on July 31, 2018 for the
treatment of thrombocytopenia in adult patients with chronic liver
disease (CLD) who are scheduled to undergo a procedure. It is currently
being commercialised in Japan and the US, where it is marketed under the
brand name Mulpleta^®.

About Shionogi
Shionogi & Co., Ltd. (“Shionogi”) is a major
research-driven pharmaceutical company dedicated to bringing benefits to
patients based on its corporate philosophy of “supplying the best
possible medicine to protect the health and wellbeing of the patients we
serve.” The company currently markets products in several therapeutic
areas including anti-infectives, pain, CNS disorders, cardiovascular
diseases and gastroenterology. Shionogi’s research and development
currently target two therapeutic areas: infectious diseases, and
pain/CNS disorders. For more information on Shionogi, please visit www.shionogi.co.jp/en/.

Forward Looking Statement
This announcement
contains forward-looking statements. These statements are based on
expectations in light of the information currently available,
assumptions that are subject to risks and uncertainties which could
cause actual results to differ materially from these statements. Risks
and uncertainties include general domestic and international economic
conditions such as general industry and market conditions, and changes
of interest rate and currency exchange rate. These risks and
uncertainties particularly apply with respect to product-related
forward-looking statements. Product risks and uncertainties include, but
are not limited to, completion and discontinuation of clinical trials;
obtaining regulatory approvals; claims and concerns about product safety
and efficacy; technological advances; adverse outcome of important
litigation; domestic and foreign healthcare reforms and changes of laws
and regulations. Also for existing products, there are manufacturing and
marketing risks, which include, but are not limited to, inability to
build production capacity to meet demand, unavailability of raw
materials and entry of competitive products. The company disclaims any
intention or obligation to update or revise any forward-looking
statements whether as a result of new information, future events or
otherwise.

References:
1.			Japanese Approval of Lusutrombopag. Available at: http://www.info.pmda.go.jp/go/pack/3399010F1022_1_02/. Last accessed April 2019
2.			FDA New Drug Application Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210923Orig1s000Approv.pdf. Last accessed April 2019
3.			Giannini EG. Aliment Pharmacol Ther. 2006; 23(8):1055-1065.
4.			Koruk M, et al. Hepatogastroenterology. 2002; 49(48):1645-1648.
5.			Aref S, et al. Hematology. 2004; 9(5/6):351-356.
6.			Peck-Radosavljevic M. Liver Int. 2017; 37(6):778-793.
7.			de Gottardi, A. et al. Clin Gastroenterol Hepatol. 2009;7(8):906-9
8.			Poordad F, et al. J Med Econ. 2012; 15:112-124.
9.			Hayashi H, et al. World J Gastroenterol. 2014; 20: 2595-2605.

Contacts

Corporate Communications, Shionogi & Co., Ltd.
Telephone:
+81-6-6209-7885

Shionogi Inc. U.S. Media
Barbara Kalavik
Telephone:
+001973-307-3373

Shionogi Europe Media
Dr. Mark Hill
Telephone: +44-7387-104-907