Lysaker, Norway and Osaka, Japan, March 19, 2012- 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<0.0001) while those were
similar between TAK-085 2g and EPA-E. - 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. |
About Pronova BioPharma ASA
Pronova is a global leader in research, development and
manufacture of lipid therapies derived from nature. Pronova
has developed the first and only EU- and FDA-approved omega-3
derived prescription drug marketed in 57 countries and the
company is in the process of developing several new,
patentable lipid derivatives. Additional information is
available on
www.pronova.com.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global
company with its main focus on pharmaceuticals. As the
largest pharmaceutical company in Japan and one of the global
leaders of the industry, Takeda is committed to strive
towards better health for patients worldwide through leading
innovation in medicine. Additional information about Takeda
is available through its corporate website, www.takeda.com.
Contacts:
Pronova BioPharma ASA
Goran Gannedahl
VP Medical & Regulatory Affairs and Resrach & Development
Tel: +47-91-55-26-26
Hamed Brodersen,
VP Investor Relations and Communications
Tel: +47-40-46-81-10
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Tel: +81-3-3278-2037
distributed by | This press release was issued by Pronova BioPharma ASA and was initially posted at http://www.pronova.com. It was distributed, unedited and unaltered, by noodls on 2012-03-19 08:40:43 AM. The issuer is solely responsible for the accuracy of the information contained therein. |