Daiwa Pharmaceutical Obtains Patent for "NKCP" in EU

Daiwa Pharmaceutical Obtains Patent for "NKCP" in EU

Daiwa Pharmaceutical newly registered a patent for “NKCP” in the EU. The product was approved as a blood viscosity reducing agent and the patent will come into force in Europe (34 countries) following Korea and Taiwan. Daiwa Pharmaceutical will continue to file the patent applications sequentially in order to obtain the patent by country.　　European Patent No.1657304

It was reported from around 1990 that the nattokinase, natto-derived fibrinolytic substance, is a subtilisin protease. However, the main active component of “NKCP” was shown to be a fragment of bacillopeptidase F different from the nattokinase in amino acid sequence after separation and purification, and analysis using various instruments.

“NKCP” was tested in safety studies required for application for Food for Specified Health Uses (FOSHU). As a result, it was confirmed to have no problem of safety in all the studies including single dose and repeated dose toxicity studies, an antigenicity study, mutagenicity study, and an excess administration study. For efficacy, it was observed to have a fibrinolytic effect on thrombi, reported for the conventional nattokinase, and further to inhibit blood coagulation and reduce blood viscosity.

The determination of blood viscosity used a method developed by Associate professor Hitosugi et al. at the Department of Legal Medicine, Dokkyo Medical University School of Medicine, in which fresh blood immediately after collection was measured with an oscillating viscometer. The blood viscosity reducing effect was confirmed in in vitro and human clinical studies, using the determination method.

Associate professor Masahito Hitosugi, a specialist in thrombosis who has been engaged in “NKCP” research for a long time and has also been involved in the current patent application said, “I intend to further clarify the mechanism of action of bacillopeptidase F in clinical studies.”

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