New production line for Omega-3 API
Structurally complete in January 2009, producing by May 2009, validation completed and first commercial batches by spring 2010
Pronova BioPharma is one of the leading companies in the research and development of marine-originated omega-3 fatty acids for the prevention of cardiovascular diseases.
The company has also established a manufacturing platform for its first commercial product Omacor (Europe) and Lovaza (US) with a dedicated plant in Sandefjord, Norway, although it does use third party manufacturing as well.
The Sandefjord plant has 130 personnel and has had NOK800m invested into it since 2004 to optimise production processes. This has increased production capacity by 300%, with 2008’s production levels at 1,201t.
Pronova expanded its manufacturing base with a new facility in Kalundborg, Sweden. The new facility required an investment of NOK1.9bn and is expected to the company’s production capability for Omacor, which is rapidly becoming an important treatment for cardiovascular disease. The facility was inaugurated in October 2009.
Construction of Kalundborg facility
The contract for construction and validation of the new facility at Kalundborg was awarded in December 2007 to NNE Pharmaplan, formerly Novo Nordisk Engineering which merged with Pharmaplan of Germany. NNE Pharmaplan was responsible for engineering, procurement, construction management and validation at Kalundborg, using over 180 engineers. The construction began properly in October 2007, and was completed ahead of schedule in 2009.
The modular plant was structurally complete in January 2009, testament to NNE Pharmaplan’s reputation of fast-tracking plant construction. The new Kalundborg facility is of a modular design and initially has an annual production capacity of 1,200t of the omega-3 API for Omacor production. There is also capacity to establish two further production modules at the new facility, each with a capacity of 600t per year.
Validation of production process
Production of low-concentrate intermediate products started in May 2009 and by the end of July 2009 the company had successfully produced three consecutive process validation (PV) batches.
This concluded the important validation of all production processes involved in manufacturing the active pharmaceutical ingredient (API) for Omacor.
The plant achieved Good Manufacturing Practices (GMP) certification in 2009. This was followed by EU regulatory filing early in the fourth quarter of 2009 and US Food and Drug Administration (FDA) filing late in the fourth quarter of 2009. The plant received FDA certification in April 2010, ahead of schedule.
Kalundborg employs approximately 100 personnel; 94 of the staff underwent a comprehensive training programme at Sandefjord as the technology they use was developed there.
Omacor/Lovaza is an EU and FDA-approved omega-3 derived prescription drug, which is prescribed as a supplement to the diet for the treatment of elevated levels of triglycerides hypertriglyceridemia (HTG). Research has linked high triglyceride levels to a number of cardiovascular diseases.
Omacor has also been approved in some markets for the secondary prevention of post-myocardial infarction. The drug has shown in a number of clinical trials to be a potent triglyceride-lowering agent as a monotherapy, but it has also proved its worth working in conjunction with other lipid-lowering compounds such as statins.
Consequently, Pronova BioPharma is involved in a number of projects to develop Omacor/Lovaza as a combination therapy with statins for mixed dyslipidemia.
Omacor/Lovaza was launched in 2005 in the US and in major European markets and it has been reported that global end-user sales of the product have increased from $144m in 2005 to $778m in 2008.
It is estimated that approximately 750,000 patients are on a prescription for Omacor/Lovaza.
The Pronova BioPharma network of partners for the marketing and distribution of Omacor/Lovaza includes GlaxoSmithKline (US), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK and Germany).