The company is investing NOK1.45-1.7bn (€189-222m) on the brand new plant in Kalundborg, Denmark, which will contribute an additional 1,200 tonnes of active ingredient per year and double the firm's current output. The new plant will be fitted out with the same technology and have the same structure as Pronova's existing site in Sandefjord, a move which the company believes will help ensure regulatory approval of the new site and allow construction to progress more efficiently.
Work on the new facility is due to begin later this month, with the plant expected to be operational and approved by regulators by the first half of 2010. Both production facilities are used to manufacture the API for the company's Omacor product (Lovaza in the US), which contains omega-3-acid ethyl esters, comprising of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
The API for Pronova's product is manufactured through a complex good manufacturing practice (GMP) compliant process of purification (removing environmental pollutants), bleaching and concentration (molecular distillation and urea complexation) of high grade fish oils. The API is therefore the result of highly purified pharmaceutical preparations of EPA and DHA ethyl esters (chemically modified forms of fatty acids), and contains a 90 per cent concentration of omega-3 ethyl esters.
Omacor is the first and only EU and US Food and Drug Administration (FDA) approved omega-3 derived prescription drug according to the company, and is prescribed to treat elevated levels of triglycerides, a condition known as hypertriglyceridemia (HTG). High triglyceride levels have been linked to a number of cardiovascular diseases. The drug has also been approved in Europe for patients having just suffered a heart attack.
Omacor/Lovaza was launched in 2005, and the company reports that global end user sales increased from $144m (€101m) in 2005 to $306m by 2006. The company concentrates on developing new lipid compounds that have more specific biological effects than natural polyunsaturated fatty acids, particularly focusing on the areas of cardiovascular/metabolic diseases and chronic inflammation.
Pronova's pipeline currently includes partnered projects to develop the firm's API through clinical trials as a monotherapy for additional indications such as atrial fibrillation, heart failure an primary prevention of Type II diabetes - all currently in Phase III.
The firm is also collaborating with external partners on additional combination therapies for HTG and mixed dislipidemia, as well as a new formulation capsule, all of which are expected to enter Phase III in 2008.