Takeda and Pronova highlight TAK-085 Japanese Ph III trial results

Japanese drug major Takeda Pharmaceutical (TYO: 4502) and Norway-based lipid therapies specialist Pronova Biopharma (PRON: NO) reported results from a Phase III study in Japan showing that TAK-085 produced a triglyceride percent change of -10.93% and -22.65% in the 2g and 4g doses (p<0.0001), respectively compared to -11.30% in the eicosapentaenoic acid ethyl ester 1.8g group in hyperlipidemia patients.

The data, presented at the 76th Annual Scientific Meeting of the Japanese Circulation Society in Fukuoka, showed no significant difference in the percent change of low-density lipoprotein cholesterol, (LDL-C), high-density lipoprotein cholesterol (HDL-C) and TC in TAK-085 group versus EPA-E group. There was no significant difference in the percent change of LDL-C, HDL-C and TC in TAK-085 treatment groups, as well as EPA-E treatment group. Furthermore there was a shift towards large buoyant LDL-C, a particle considered to be less atherogenic, in TAK-085 4 g compared to EPA-E. Both TAK-085 2g and 4g were safe and

TAK-085, discovered by Pronova, is the omega 3-derived prescription drug containing highly concentrated and purified EPA-E (eicosapentaenoic acid ethyl ester) and DHA-E (docosahexaenoic acid). It is already on the market in 56 countries including the USA under the trade name Lovaza and most European countries, using the name Omacor. The companies filed for Japanese approval last year (The Pharma Letter September 29, 2011).