Results from phase 3 trial of TAK-085 for the treatment of Hyperlipidemia

Pronova BioPharma ASA (“Pronova”) and Takeda Pharmaceutical Company Limited (“Takeda”) today announced the results from a phase 3 trial of TAK-085 (International Nonproprietary Name (INN): omega-3-acid ethyl esters 90) in Japan, for the Treatment of Hyperlipidemia, at the 76th Annual Scientific Meeting of the Japanese Circulation Society in Fukuoka.

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 57 countries including the U.S. and most European countries. In 2005, Takeda and Pronova entered into a License and Supply Agreement in which Takeda was granted the exclusive development and marketing right to this product in Japan. Takeda submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare for TAK-085 in September 2011.

Pronova and Takeda will continue to work closely together for obtaining the approval to ensure that the companies contribute to patients with hyperlipidemia and healthcare professionals in Japan by providing the promising treatment option for them.

Summary of phase 3 results presented at the meeting (Abstract #FRS-029)

Objective
To examine the efficacy and safety of TAK-085, 2g (once daily) and 4g (2g twice daily), in Japanese patients with hypertriglyceridemia (baseline TG : 150-750 mg/dL).

Study Design
Randomized, controlled, double-blind, multicenter trial

Control
EPA-E 1.8g/day 0.6g thrice daily

Patients
611

Treatment period
12 weeks

Primary endpoint
Percent change of triglyceride from baseline at the end of treatment (Week 12)

Secondary endpoints
Percent change of other lipid parameters, such as LDL-C, HDL-C and TC from baseline at the end of treatment (Week 12)

Results

• The percent change of triglyceride was -10.93, -22.65 and -11.30 in the TAK-085 2g, TAK-085 4g, and EPA-E 1.8g, respectively. The reduction of triglyceride by TAK-085 4g was statistically greater than that by EPA-E (p- 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 of TAK-085 2g and 4g were safe and well tolerated, with a safety profile comparable to EPA-E.