Pronova’s hypertriglyceridemia drug TAK-085 superior to EPA in Phase III trial


Lysaker/Osaka – Norwegian Pronova and its Japanese marketing partner Takeda Pharmaceuticals have a good chances of entering the Japanese drug market with their compound TAK-085, an omega-3 acid ethyl ester for treatment of for patients with hypertriglyceridemia. In a Phase III trial, a 4 gramme dose of TAK-085 reached the primary endpoint of percent change of from baseline in triglycerides at the end-of-treatment after 12 weeks and was superior to the active comparator EPA (1.8 grammes), which is already approved for the Japanese market. A dose of 2 grammes of TAK-085 was as effective as EPA. In addition, none of the drugs, which were tested on 200 patients each, demonstrated any statistically significant change in LDL cholesterol. TAK-085, which is already approved in Europe and the US, was safe and well tolerated, with the safety profile comparable to EPA. Takeda and Pronova said they are aiming to submit a New Drug Application in Japan before March 31, 2012. TAK-085 is a Omega 3-derived prescription drug containing EPA-E (highly purified eicosapentaenoic acid ethyl ester) and DHA-E (highly purified docosahexaenoic acid) and is marketed as LovazaTM in the U.S. with the indication of an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥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).



Oslo – Norwegian cancer specialist Clavis Pharma ASA announced yesterday that its US-based development partner Clovis Oncology for CP-4126 has signed an agreement with Ventana Medical Systems, Inc. to develop a companion...



Oslo/Levanger – A report released by the Research Council of Norway (RCN) proposes setting up a national biobank company in Norway. After analysing ethical, judicial and political arguments, the study ordered by the Norwegian...



Cancer drug developer Clavis Pharma ASA (Oslo) has appointed Olav Hellebø as its new CEO. Hellebø, who joined Clavis Pharma from UCB at the beginning of February, is an experienced pharmaceutical executive who has held senior...



Oslo – Norwegian drug delivery specialist Clavis Pharma ASA has received an unsecured loan of NOK20m (EUR2.4m) from the governmental body Innovation Norway to kick-off a Phase III registration trial with elacytarabine in 350...



Oslo – Norwegian drug delivery specialist Clavis Pharma ASA has received an unsecured loan of NOK20m ($3.2m) from Innovation Norway to kick-off a phase III registration trial with elacytarabine in patients with late-stage acute...



Oslo/Boulder – Norwegian drugmaker Clavis Pharma has inked a cancer drug development deal worth around US$380m with US-based Clovis Oncology, a newly formed oncology company led by former Pharmion Corporation executives. The deal...



Oslo – Norway’s Algeta ASA surprised analysts with a EUR560m licensing pact for the company’s lead drug – an experimental radiotherapy that targets cancerous bone cells. Licensing partner Bayer Schering Pharma will pay US$61m in...



Oslo – Prof. Harald Stenmark, head of the Centre for Cancer Biomedicine at the Norwegian Radium Hospital, has received one of the Advanced Grants distributed by the European Research Council. The oncologist will now receive...



Oslo – Clavis Pharma ASA, a Norwegian drug developer focused on cancer therapies, has reported that it has received EUR14m (NOK 129m) in additional funding through a private placement of 10.7 million shares led by Carnegie ASA...

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