Pronova gets EU nod for Omacor manufacturing plant
pharmafile | December 14, 2009 | News story | Manufacturing and Production |Â Â Denmark, Omacor, PronovaÂ
Pronova BioPharma has been granted approval by EU regulatory authorities for its new manufacturing plant in Kalundborg, Denmark, that will be used to supply the active ingredient for Omacor, the firm’s omega-3 fatty acid-based drug.
Pronova said the new plant would help it meet a “strong increase in product demand” for Omacor, which is sold to treat elevated levels of triglycerides in the blood in 46 countries around the world. In Europe it is also approved for secondary prevention of post-myocardial infarction.
Omacor – sold as Lovaza in the US – is Pronova’s only commercialised product but has been a spectacular success for the company. In the first nine months of 2009 the product helped the Norwegian company reach revenues of 1,252 million kroner ($218 million), up 33% on the same period of 2008.
The plant will almost double Pronova’s capacity to make the active ingredient in Omacor and should start commercial deliveries in the first quarter of 2010, as planned, said the firm.
At the moment it meets demand from another production unit in Sandefjord, which can produce around 1,600 tonnes of omega-3 fatty acid a year from purified, bleached and concentrated fish oil.
Kalundborg adds another 1,200 tonnes of annual capacity, and can be expanded to include another two 600 tonne production units if required in the future, said the company.
The Kalundborg facility still has to receive clearance from the US Food and Drug Administration (FDA) and this is expected in the second half of 2010, said Pronova.
“This approval marks one of the last major milestones for the important and prestigious investment project in Kalundborg,” said the company’s chief executive Morten Jurs.
The company produced around 390 tonnes of the ingredient to its Omacor distributors in the third-quarter, and expects demand in 2010 to be in the 1,800-2,000 tonne range, although this could be affected by potential generic competition in the European market in 2010.
One generic rival, Institute Biochimique SA, saw its application to market a version of the drug rejected by the Italian regulatory authorities (AIFA) recently. The case has gone to appeal and a verdict is expected next year.
To stave off the impact of generic competition Pronova is developing a fixed-dose combination of the omega-3 ethyl ester ingredient in Omacor with simvastatin, in partnership with Sigma-Tau, which could reach the market in 2010/2011.
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