Top-line Results of the Pivotal Phase 3 Clinical Trial of TAK-085 in Japan for Treatment of Hypertriglyceridemia
(Thomson Reuters ONE) -
May 10, 2011, Osaka, Japan and Lysaker, Norway --- Takeda Pharmaceutical
Company Limited (Osaka, Japan, "Takeda") and Pronova BioPharma ASA (Lysaker,
Norway, "Pronova") today jointly announced the top-line results of a pivotal
phase 3 clinical trial of TAK-085 (Compendial name: omega-3 acid ethyl esters
90).
This is a randomized, double-blind, phase 3 clinical trial to evaluate the
efficacy and safety of TAK-085 for patients with hypertriglyceridemia, in
comparison with an active comparator, EPA (eicosapentaenoic acid) product
already approved in Japan.
The trial consists of three arms, with approximately 200 subjects each, of
dosage and administration of 2g and 4g of TAK-085 a day respectively, and 1.8g
of EPA a day. The trial demonstrated 4g of TAK-085 was statistically superior to
1.8g of EPA, the recommended daily dose, in lowering the percent change from
baseline in triglycerides at the end-of-treatment (primary endpoint measured at
12 weeks). Both two grams of TAK-085 and 1.8g of EPA significantly reduced the
same primary endpoint. Additionally, this study demonstrated no statistically
significant change in LDL cholesterol in any of the three groups. TAK-085 was
safe and well tolerated, with the safety profile comparable to EPA.
Takeda will conduct the full-analysis of the results together with Pronova, and
is aiming to submit a New Drug Application in Japan within this fiscal year
ending March 31, 2012.
# # #
About TAK-085
Developed by Pronova, this is the Omega 3-derived prescription drug containing
EPA-E (highly purified eicosapentaenoic acid ethyl ester) and DHA-E (highly
purified docosahexaenoic acid). It is marketed as Lovaza(TM) in the U.S. with
the indication of an adjunct to diet to reduce triglyceride (TG) levels in adult
patients with severe (equal to or in excess of 500 mg/dL) hypertriglyceridemia.
Beside the hypertiglyceridemia indication, in certain European countries
including Italy, France, Germany, Spain, the UK, it is also marketed for,
adjuvant treatment in secondary prevention after myocardial infarction, in
addition to other standard therapy (e.g. statins, antiplatelet drugs,
betablockers, ACE inhibitors).
In 2005, Takeda and Pronova entered into a License- and Supply Agreement in
which Takeda was granted an exclusive development and marketing right of this
product in Japan.
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.
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 over 50 countries and
the company is in the process of developing several new, patentable lipid
derivatives. Additional information is available on www.pronova.com
Contacts:
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Tel: + 81 (3) 3278-2037
Pronova BioPharma ASA
Hamed Brodersen,
VP Investor Relations and Communications
Tel: +47 40 46 81 10
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
TAK - 085:
http://hugin.info/137506/R/1513911/449856.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Pronova BioPharma ASA via Thomson Reuters ONE
[HUG#1513911]
Unternehmensinformation / Kurzprofil:
Datum: 10.05.2011 - 08:00 Uhr
Sprache: Deutsch
News-ID 54441
Anzahl Zeichen: 4719
contact information:
Town:
Lysaker
Kategorie:
Business News
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"Top-line Results of the Pivotal Phase 3 Clinical Trial of TAK-085 in Japan for Treatment of Hypertriglyceridemia"
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