Announcement for Launching "Epoetin Alfa BS Injection [JCR]", a Treatment Agent for Renal Anemia

Kissei Pharmaceutical Co., Ltd.
JAPAN CHEMICAL RESERCH PHARMACEUTICALS CO., LTD.

Kissei Pharmaceutical Co., Ltd. (President: Mutsuo Kanzawa) (hereafter, Kissei) announced that Kissei will launch "Epoetin alfa BS injection [JCR]", a treatment agent for renal anemia, on May 27 (Thu) in Japan.

"Epoetin alfa BS injection [JCR]" (hereafter, this drug) is a recombinant human erythropoietin product (hereafter, EPO product), which was produced by Japan Chemical Research Pharmaceuticals Co., Ltd. (President: Shin Ashida) (hereafter, JCR) through the success of industrial production based on completely serum-free medium.

This drug is the first-ever biosimilar for EPO products approved in Japan, which was co-developed by Kissei and JCR and approved with controlled clinical study comparing with the existing biopharmaceutical "epoetin alfa"(general name), about its equivalence and homogeneity.

This drug's approved indications are renal anemia on dialysis and immature infant anemia. Renal anemia disease, which is mainly due to the low production of EPO, hematogenous factor caused by chronic kidney disease, is the complication frequently seen with dialysis patients. The population of dialysis patients increase every year and go up to 282 thousands patients as of the end of 2008. Many dialysis patients receive therapy for renal anemia with the EPO product.

Kissei is in charge of sales, and Kissei and JCR will jointly promote to medical institutes. Both companies are aiming at contributing to QOL of patients and improvement in medical treatment through providing a new treatment for renal anemia.

<Summary of Epoetin Alfa BS Injection [JCR]>
Product name:
Epoetin alfa BS injection 750 syringe [JCR], Epoetin alfa BS injection 1500 syringe [JCR], Epoetin alfa BS injection 3000 syringe [JCR]
Epoetin alfa BS injection 750 [JCR], Epoetin alfa BS injection 1500 [JCR], Epoetin alfa BS injection 3000 [JCR]
　
Generic name:
Epoetin kappa (genetical recombination) [epoetin alfa biosimilar 1]
　
Indications:
1. Renal anemia on dialysis
2. Immature infant anemia
　
Dosage and Administration:
1. Renal anemia on dialysis
For intravenous use, the usual adult starting dosage is 3,000 IU of epoetin alfa (genetical recombination) [biosimilar 1] 3 times a week, to be injected as slowly as possible.
The maintenance dosage for adults after improvement of anemia should usually be either 1,500 IU intravenous injection 2 - 3 times a week or 3,000 IU twice a week. Hemoglobin concentrations of about 10g/dL (30% of hematocrit value) should be the target values for anemia improvement.
The dosage should be adjusted according to the severity of anemia, age of patients, etc. In any case, the maintenance dosage should not exceed 3,000 IU injection 3 times a week.
2. Immature infant anemia
The usual dosage for subcutaneous use is 200 IU/kg of epoetin alfa (genetical recombination) [biosimilar 1] twice a week.
However, the treatment should be discontinued when the patient escapes early anemia of prematurity and the clinical conditions are considered to stabilize with the hemoglobin concentration standing approximately at 10g/dL (30% by hematocrit value).
The dosage should be adjusted according to the severity of anemia.
　
Manufactured by: Japan Chemical Research Pharmaceuticals Co., Ltd.
　
Distributed by: Kissei Pharmaceutical Co., Ltd.
　
National Health Insurance prices:
Epoetin alfa BS injection 750 syringe [JCR] (750IU0.5ml 1 syringe): 848Yen
Epoetin alfa BS injection 1500 syringe [JCR] (750IU1ml 1 syringe): 1,491Yen
Epoetin alfa BS injection 3000 syringe [JCR] (750IU2ml 1 syringe): 2,622Yen
Epoetin alfa BS injection 750 [JCR] (750IU0.5ml 1 bottle): 1,113Yen
Epoetin alfa BS injection 1500 [JCR] (1500IU1ml 1 bottle): 1,938Yen
Epoetin alfa BS injection 3000 [JCR] (3000IU2ml 1 bottle): 3,377Yen
　
Launch date:
Epoetin alfa BS injection 750, 1500, 3000 syringe [JCR]: May 27 (Thu), 2010
Epoetin alfa BS injection 750, 1500, 3000 [JCR]: June 30 (Wed), 2010
　
Feature:
1. This drug is the first-ever biosimilar for EPO products approved in Japan.
2. The equivalence in efficacy (effect of improvement for anemia) with the existing EPO products was confirmed　with phase II/III clinical studies.
3. This drug is a biopharmaceutical produced by completely serum-free medium after master cell bank preparation.
4. Adverse reactions (including observed abnormal laboratory data) to this drug for renal anemia on dialysis were reported in 73 (23.6%) of 309 patients (clinical studies' total patients) treated. The main adverse reactions were increased blood pressure in 17 events (5.5%), headache in 6 events (1.9%), eosinophilia in 5 events (1.6%), rash in 5 events (1.6%) and others.