NorwayNorway

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

11.05.2011

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).

NorwayNorway

05.04.2011

Oslo – Norwegian Algeta ASA has entered a research collaboration with Genzyme to evaluate the potential of its Thorium platform Under the terms of the agreement, Genzyme will provide access to a novel tumour-targeting antibody,...

NorwayNorway

05.04.2011

Trondheim – Norway-based APIM Therapeutics AS has received a follow-up investment from Sarsia Seed, one of its previous investors. APIM focusses on novel drug candidates that potentiate the action of current chemo­therapeutics to...

NorwayNorway

04.11.2010

Oslo – Norwegian diagnostic specialist DiaGenic ASA has raised NOK70m (EUR 8.5m) through the sale of 140 million shares at NOK0.50 per share in a private placement to new and existing investors. DnB NOR Markets acted as manager...

NorwayNorway

03.11.2010

Oslo – The Oslo Cancer Cluster and the Shanghai Institute of Materia Medica (SIMM), have signed a memorandum of understanding aimed at accelerating the development and adoption of new cancer therapies. Overall, the collaboration...

NorwayNorway

18.09.2010

Oslo/Berlin – Algeta is cashing in on its lead product Alpharadin, a targeted alpha-radiopharmaceutical in clinical trials for treating bone metastases in cancer patients. Bayer Schering Pharma has agreed to pay the Norwegian...

NorwayNorway

11.07.2010

Lysaker – Norwegian biopharmaceutical company PCI Biotech Holding ASA has strengthened the company’s equity by a11m (NOK90m) through a share issue of 2.25 million shares with preemptive subscription rights for existing...

NorwayNorway

12.05.2010

Oslo – In Norway, a discussion has begun on how to continue to support biotechnology after the current National Programme for Research in Functional Genomics in Norway (FUGE) comes to a close in 2011. Efforts to draw up a...

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