Presentation of Highlight Results from Phase 3 Trial of TAK-085 in Japan for the Treatment of Hyperlipidemia at the 76th Annual Scientific Meeting of the Japanese Circulation Society
(Thomson Reuters ONE) -
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 76(th) 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 onwww.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
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originality of the information contained therein.
Source: Pronova BioPharma ASA via Thomson Reuters ONE
[HUG#1594666]
Unternehmensinformation / Kurzprofil:
Datum: 19.03.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 125810
Anzahl Zeichen: 6675
contact information:
Town:
Lysaker
Kategorie:
Business News
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