Press Release

ASKA Pharmaceutical Receives Approval for Partial Change ofManufacturing and Marketing Approval for RIFXIMA® TABLETS (Rifaximin)
for Pediatric Indication
TOKYO, March 26, 2024 – ASKA Pharmaceutical Co., Ltd. (Head Office: Minato-ku, Tokyo/
President, Representative Director: Sohta Yamaguchi, hereinafter referred to as “ASKA”), a
subsidiary of ASKA Pharmaceutical Holdings Co., Ltd. (TSE:4886), announced that ASKA
received approval for partial change of the manufacturing and marketing approval of RIFXIMA®
TABLETS (generic name: rifaximin, hereinafter “the Product”) for the pediatric indication for theimprovement of hyperammonemia in hepatic encephalopathy.
The Product is a poorly absorbable rifamycin antimicrobial agent discovered and developed byAlfasigma S.p.A. (Head Office: Bologna, Italy) and in-licensed by ASKA. In September 2016,
ASKA received manufacturing and marketing approval for the indication of “improvement ofhyperammonemia

inhepaticencephalopathy.”

TheJapaneseSocietyforPediatric

Gastroenterology, Hepatology and Nutrition has submitted a request for approval of this Product’s
pediatric indication to the Ministry of Health, Labour and Welfare.
Overview of approval(The information related to this approval is as underlined below.)
Product name:RIFXIMA® TABLETS 200mg

Generic name:

Rifaximin

Indications:Improvement of hyperammonemia in hepatic encephalopathy

Dosage and Administration:

The usual oral dosage for adults and children is 400 mg ofrifaximin three times daily immediately after meals.

ASKA expects that this Product will provide a new treatment option for patients and medical
professionals and contribute to the improvement of their quality of lives.
About RIFXIMA® TABLETS
The Product functions by exerting an antibacterial effect on the intestinal microflora. Even whentaken orally, it is hardly absorbed into the body and suppresses ammonia-producing bacteria inthe digestive tract. As a result, it is effective against hepatic encephalopathy by inhibiting theincrease in blood ammonia concentration, which is considered to be a major factor in hepaticencephalopathy.

1/2About Hepatic encephalopathy
Hepatic encephalopathy is a severe complication of hepatic dysfunction, such as hepatitis andcirrhosis, and is mainly associated with neuropsychiatric symptoms. Among the various factors
contributing to the onset of hepatic encephalopathy, it is believed that the increased bloodconcentration of ammonia, a breakdown product of intestinal bacteria from dietary protein,negatively affects neurological functions.
When the liver is functioning normally, it metabolizes ammonia. However, if liver function declines
due to cirrhosis or other causes, ammonia metabolism becomes inadequate, leading to increased
ammonia concentration in the blood. This can result in decreased brain function and various
neuropsychiatric symptoms. Hepatic encephalopathy is characterized by impaired consciousness
and behavioral abnormalities, and in severe cases, it may progress to coma, which can be lifethreatening.

Media Contacts

ASKA Pharmaceutical Holdings Co., Ltd.
Corporate Planning Department
Tel: +81-3-5484-8366
Email: kouhou@aska-pharma.co.jp

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