NNE wins Pronova contract

By Anna Lewcock

- Last updated on GMT

Related tags Omega-3 fatty acid

NNE Pharmaplan has won a contract with Pronova BioPharma to build
the company's new pharma production facility in Kalundborg,

Pronova announced plans to double production capacity for its marine-derived active pharmaceutical ingredient (API) almost two months ago, this morning signing an agreement awarding the construction contract for the new plant to NNE.

Pronova is investing NOK1.45-1.7bn ($0.27-0.31bn) in the new facility, which will provide an additional 1,200 tonnes of API per year to satisfy demand for the company's omega-3 based pharmaceuticals.

NNE will take responsibility for engineering, procurement, construction management and validation of the good manufacturing practice (GMP) plant, with the project expected to last approximately 18 months.

Pronova hopes to have the facility up and running with the necessary regulatory approvals by the first half of 2010.

According to Pronova's CEO, Tomas Settevik, a significant factor in the company's decision to award the construction contract to NNE was the fact that the engineering firm's outline for the facility's construction was four to six months shorter than any of Pronova's other options.

"[This] enables us to continue our fast growth and ensures that we are well positioned to meet the global market's accelerating demand for our products," said Settevik.

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.

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.

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