NEWS RELEASE
March 15, 2023

Launch of MonoVerⓇ for I.V. injection 500mg/1000mg for the treatment ofiron deficiency anemia

Kyoto, Japan, March 15, 2023 - Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Headquarters,Kyoto; President, Toru Nakai) announced today that it has launched MonoVerⓇ for I.V. injection
500mg/1000mg for the treatment of iron deficiency anemia in Japan.
Iron deficiency anemia (IDA) is the anemia caused by iron deficiency and reduction of hemoglobin
synthesis associated with heavy uterine bleeding, post-partum hemorrhage, gastrointestinalbleeding, poor absorption of iron through gastrointestinal tract and other relevant diseases. Inaddition to symptoms such as palpitations, shortness of breath, and easy fatigue due to anemia,
concave nails (koilonychia) due to iron deficiency are also observed. To treat IDA, it is fundamental
to treat the underlying cause of IDA and replenish iron stores. Regarding iron replenishment, oraliron can be the first choice, and intravenous iron can be selected when oral iron preparations areinsufficient due to iron loss caused by massive bleeding, inappropriate to be used due to side
effects or poor absorption.
MonoVerⓇ is an intravenous iron preparation that contains ferric derisomaltose, a high-stability
matrix structure binding with iron and low immunogenicity linear oligosaccharide (derisomaltose),as API. MonoVerⓇ is considered to be a choice for the IDA treatment as the maximum single dose1000 mg enables full iron correction in a short period with few times of infusion.
Nippon Shinyaku licensed in MonoVer Ⓡ from Pharmacosmos A/S (Headquarters, Holbaek,Denmark; President & CEO, Tobias S. Christensen) in December, 2016. Marketing approval of
MonoVerⓇ was obtained in March, 2022. MonoVerⓇ has been approved in 47 countries.
Nippon Shinyaku aims to contribute to the treatment of IDA by appropriately delivering MonoVerⓇ
to patients.

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Summary of MonoVerⓇ
Brand

name

MonoVerⓇ for I.V. injection 500mg
MonoVerⓇ for I.V. injection 1000mg

Generic name

Ferric Derisomaltose

Date of approval

March 28, 2022

Date of NHI reimbursement
price listing
Date of launch
Number of approval

March 15, 2023
March 15, 2023
MonoVerⓇ for I.V. injection 500mg: 30400AMX00183000
MonoVerⓇ for I.V. injection 1000mg: 30400AMX00184000
MonoVerⓇ for I.V. Injection 500mg: Aqueous injection containing ferric

Dosage Forms and Strengths

derisomaltose as ferric iron (500mg) in 1 vial (5mL)
MonoVerⓇ for I.V. Injection 1000mg: Aqueous injection containing ferricderisomaltose as ferric iron (1000mg) in 1 vial (10mL)

Indication

Iron deficiency anemia
Generally, in adults with BW ≥ 50kg, the single dose should be up to1000mg iron once a week intravenous drip infusion, or up to 500mg ironup to twice a week slow intravenous bolus injections.
Generally, in adults with BW < 50kg, the single dose should be up toDosage and Administration

20mg/kg iron once a week intravenous drip infusion, or up to 500mg ironup to twice a week slow intravenous bolus injections.
While the total iron dose varies by patient’s Hb and body weight, themaximum total dose is 2000mg iron (or 1000mg iron in adults with BW< 50kg).

NHI reimbursement price
Packaging unit

MonoVerⓇ for I.V. injection 500mg: JPY 6,189/vial (500mg/5mL)
MonoVerⓇ for I.V. injection 1000mg: JPY 12,377/vial (1000 mg/10 mL)
MonoVerⓇ for I.V. injection 500mg: 5mL×5 vials
MonoVerⓇ for I.V. injection 1000mg: 10mL×5 vials

2/3About Pharmacosmos A/SPharmacosmos Group, headquartered in Holbaek, Denmark, and founded in 1965, is a highly
specialized company focused on carbohydrate chemistry and a global leader in the developmentof innovative treatments for patients suffering from iron deficiency and iron deficiency anemia. Withaffiliates in the UK, Nordics, Germany, the USA, and China, as well as through partners,
Pharmacosmos markets its products across the world. With a strong and ongoing commitment toR&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along withdeep expertise in the synthesis of iron-carbohydrate complexes. For more information, please visit
https://www.pharmacosmos.com/.
About Nippon Shinyaku
Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,”
we aim to be an organization trusted by the community through creating unique medicines that willbring hope to patients and families suffering from illness. Please visit our website(https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.

Contact
Corporate Communications Dept., Nippon Shinyaku Co., Ltd.
FAX: +81-75-321-9128

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