NEWS RELEASE
March 28, 2022

Marketing approval of MonoVer for I.V. injection 500mg/1000mg by MHLW
for the treatment of iron deficiency anemia

Kyoto, Japan, March 28, 2022 - Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Headquarters,Kyoto; President, Toru Nakai) announced as of today that the Ministry of Health, Labour andWelfare (MHLW) has approved marketing authorization of MonoVer for I.V. injection
500mg/1000mg (ferric derisomaltose/NS-32) for the treatment of iron deficiency anemia.
Iron deficiency anemia (IDA) is the anemia caused by iron deficiency and reduction ofhemoglobin synthesis associated with heavy uterine bleeding, post-partum hemorrhage,gastrointestinal bleeding, poor absorption of iron through gastrointestinal tract and otherrelevant diseases. Typical symptoms including palpitation, shortness of breath, fatigue, andother symptoms such as concave nails (koilonychia) caused by iron deficiency arerecognized. To treat IDA, it is fundamental to treat the underlying cause of IDA and replenish
iron stores. Regarding iron replenishment, oral iron can be the first choice, and intravenous
iron can be selected when oral iron preparations are insufficient due to iron loss caused bymassive 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 themaximum single dose 1000mg enables full iron correction in a short period with few times ofinfusion.
Nippon Shinyaku licensed in the product from Pharmacosmos A/S (Headquarters, Holbaek,Denmark; President & CEO, Lars Christensen) in December, 2016. This marketing approval
is based on the results from three Japanese Phase 3 trials for IDA with heavy uterine bleeding,gastrointestinal bleeding, and post-partum hemorrhage. The product has been approved inmore than 46 countries.

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Nippon Shinyaku aims to contribute to the treatment of iron deficiency anemia byappropriately delivering MonoVer to patients.
Summary of MonoVer
Product Name
MonoVer for I.V. injection 500mg/1000mg
JAN
Ferric derisomaltose
Dosage Forms
MonoVer for I.V. Injection 500 mg: Aqueous injection containing ferricand Strengths
derisomaltose as ferric iron (500 mg) in 1 vial (5 mL)
MonoVer for I.V. Injection 1000 mg: Aqueous injection containing
ferric derisomaltose as ferric iron (1000 mg) in 1 vial (10 mL)
Indications andIron deficiency anemia
UsagesDosage andGenerally, in adults with BW ≥ 50 kg, the single dose should be up toAdministrations
1000 mg iron once a week intravenous drip infusion, or up to 500 mg
iron up to twice a week slow intravenous bolus injections.
Generally, in adults with BW < 50 kg, the single dose should be up to20 mg/kg iron once a week intravenous drip infusion, or up to 500 mg
iron up 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 2000 mg iron (or 1000 mg iron in adults withBW < 50 kg).
ABOUT PHARMACOSMOS A/SPharmacosmos Group, headquartered in Holbaek, Denmark, and founded in 1965, is ahighly specialised company focused on carbohydrate chemistry and a global leader in thedevelopment of innovative treatments for patients suffering from iron deficiency and irondeficiency anaemia. With companies in the UK, Nordics, Germany, the USA, and China, as
well as through partners, Pharmacosmos markets its products across the world. With astrong and ongoing commitment to R&D, Pharmacosmos is able to leverage a uniquecarbohydrate production platform along with deep expertise in the synthesis of ironcarbohydrate complexes.
ABOUT NIPPON SHINYAKU CO., LTD.
Our mission is to help people lead healthier and happier lives. Through creating unique
medicines that will bring hope to patients and families struggling with illness, we aim to be anorganization trusted by the community. Please visit our website (https://www.nipponshinyaku.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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