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Oct. 16, 2009Print(PDF/50KB)Products

Therapeutic agent for hepatocellular carcinoma "MIRIPLA" obtained manufacturing and marketing approval

Dainippon Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) announces that the Company has obtained a manufacturing and marketing approval for "MIRIPLA® for intra-arterial injection 70mg" (generic name: miriplatin hydrate), a therapeutic agent for hepatocellular carcinoma in Japan as of October 16, 2009 from Ministry of Health, Labor and Welfare.

"MIRIPLA®" is first suspended in an oily lymphographic agent and then administered through hepatic artery into hepatocellular carcinoma. As such an oily lymphographic agent, the Company has "MIRIPLA® suspension vehicle 4mL" (generic name: iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil), which is approved for suspending MIRIPLA®. The manufacturing and marketing approval for this suspension vehicle was obtained on August 20, 2009 from the competent Ministry.

"Lipiodolization" or "Chemo-lipiodlization" is one of the standard methods for treating hepatocellular carcinoma where an anticancer drug is suspended in an oily lymphographic agent (iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil) and then administered into hepatic artery. The Company has carried out a research program to discover an anticancer drug suitable for this treatment and succeeded in development of a lipophilic platinum complex, miriplatin which has high affinity to iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil.

MIRIPLA® has a high suspensibility in "MIRIPLA® suspension vehicle 4mL ". Some of the characteristics of MIRIPLA® are: it accumulates and stays in a tumor after the administration into hepatic artery, platinum component is released gradually over a long duration and yet exposure to entire body is minor.

In clinical tests on hepatocellular carcinoma, satisfactory anti-tumor effects were confirmed not only on patients of initial treatment but also on patients who relapsed after treatment such as hepatic resection. Some side effects were observed, but they were regarded as those generally observed under chemo-lipiodolization therapy, and they were thought to be tolerable at medical institutions familiarized with this treatment. There was no adverse event on vessel disorder in hepatic artery related to this drug.

The Company has an intention to launch both "MIRIPLA® for intra-arterial injection 70mg" and "MIRIPLA® suspension vehicle 4mL" after they are listed on the national health insurance drug price standard. As a result of launching of MIRIPLA®, the Company expects to increase the line-up of products for the liver diseases, which includes Sumiferon®, a natural interferon-alpha product, and to further contribute to the total care of liver diseases.

(Reference)

Profile of MIRIPLA®
[Brand name] MIRIPLA® for intra-arterial injection 70mg
[Generic name] miriplatin hydrate
[Content/Description] 70mg of miriplatin contained in one vial (equivalent to 71.65mg of miriplatin hydrate)
[Indication] Lipiodolization in hepatocellular carcinoma
[Dose and Administration] 70mg of miriplatin is suspended in 3.5mL of suspension vehicle for this drug, and administered once a day through catheter inserted into hepatic artery.
Administration of miriplatin-suspension ends when tumor vessel is filled with the drug, provided that the upper limit should be 6mL per administration (equivalent to 120mg of miriplatin). An observation period of 4 weeks or longer is required in the case of repeated administration.
[Manufacturer and Distributor] Dainippon Sumitomo Pharma
Profile of "the suspension vehicle"
[Brand name] MIRIPLA® suspension vehicle 4mL
[Generic name] iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil
[Content/ Description] 4mL of this liquid contained in one ampule
[Indication] For suspending MIRIPLA® for intra-arterial injection 70mg
[Dosage and Administration] 3.5mL of this suspension vehicle added to 70mg of miriplatin
[Manufacturer and Distributor] Dainippon Sumitomo Pharma