Norwegian pharmaceutical company opens new Danish plant

 

Production of the company's active pharmaceutical ingredient is already well under way at this plant when the official opening takes place. The first commercial deliveries are due in the first quarter of 2010.

 

The factory was certified earlier this week to good manufacturing practice. All that now remains are final approvals from the European Union and the USA, which are expected to be secured in the first and second halves of next year respectively.

 

Until these approvals are in place, the Kalundborg facility will deliver intermediate products to Pronova BioPharma's existing factory at Sandefjord south of Oslo.

 

The new plant has cost some NOK 1.9 billion, and its completion marks the start of a new phase in the development of the fast-growing pharmaceutical company.

 

"This is an important milestone for us," says chief executive Morten Jurs at Pronova BioPharma. "Our new Kalundborg plant puts us in a good position to handle rapidly expanding demand for Omacor®.

"That gives us opportunities to make a further commitment to boosting the growth potential - including new markets, indications and pharmaceuticals based on marine omega-3 fatty acids."

 

All the company's production has so far taken place at the Sandefjord factory, which has been expanded several times in line with rising demand.

 

It currently has about 152 employees and an annual production capacity of roughly 1 200 tonnes. The Kalundborg plant will have a similar capacity but with only 108 personnel.

 

Several locations were assessed for the new factory. When Kalundborg was ultimately chosen, weight was given in part to good infrastructure, technical services and willingness from the local authority, and good availability of personnel, contractors and suppliers with pharmaceutical expertise.

 

Technology in the new facility copies the Sandefjord factory, and its Danish workforce has received extensive training in Norway. That means they are qualified to operate the new plant from day one.

 

"Construction of the technically advanced production plant has been completed ahead of the deadline set when work began in the autumn of 2007," says Mr Jurs. "Our project team has done a fantastic job."

 

Omacor® is the first and only prescription pharmaceutical derived from omega 3 to have secured approvals both in the EU and from the US Food and Drugs Administration.

 

It is prescribed as a supplement to dietary changes for treating enhanced levels of triglyceride fats in the blood (hypertriglyceridemia), associated with a number of cardiovascular conditions.

 

Omacor® is also approved in most of the major EU countries and certain Asian markets as a supplement to the standard treatment for patients who have suffered a heart attack.

 

Documented as an effective and safe pharmaceutical, Omacor® acts as a complement to other lipid-reducing products such as statins. It is protected by a number of patents covering product, process, use (specific indications) and formulation.

 

Further information from:
Hilde H Steineger, vice president investor relations and corporate communications, Pronova BioPharma ASA, +47 48 00 42 40
Kjetil Olsen, president, Pronova BioPharma Danmark A/S +47 90 61 43 66

 

Pronova BioPharma in brief
Pronova BioPharma is a world leader for research into and the development and production of pharmaceuticals derived from marine omega-3 fatty acids.

 

Its first commercial product is sold under the Omacor® brand in a number of European and Asian countries, and as Lovaza(TM) in the USA.

 

Omacor®/Lovaza(TM) is made by a complex production process at the company's factory in Sandefjord, Norway. A second plant built at Kalundborg in Denmark is expected to become operational in the first quarter of 2010.

The product is the first and only prescription pharmaceutical derived from omega-3 to have secured approvals both in the EU and from the US Food and Drugs Administration (FDA).

 

It is prescribed as a supplement to dietary changes for treating hypertriglyceridemia (HTG) - enhanced triglyceride fats in the blood. Very high levels of such fats can be associated with a number of cardiovascular conditions.

Omacor® is also approved in most of the major EU countries and certain Asian markets as a supplement to the standard treatment for patients who have suffered a heart attack.

 

Documented as an effective and safe pharmaceutical, Omacor® acts as a complement to other lipid-reducing products such as statins. It is protected by a number of patents covering product, process, use (specific indications) and formulation.

 

Pronova BioPharma's global network of licensed distribution partners includes GlaxoSmithKline PLC (USA), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others). This network embraces a dedicated corps of roughly 2 650 salesreps.

 

Omacor®/Lovaza(TM) was launched in the USA and major European markets such as France and Spain in 2005. Analyst IMS Health reports that global end-user sales of the product rose from USD 144 million in 2005 to USD 778 million in 2008.

 

Annual ongoing end-user sales were estimated in June to total USD 1.2 billion, and the company estimates that more than 1.28 million patients are now being treated with Omacor®/Lovaza(TM).

Pronova BioPharma had operating revenues of NOK 1 302 million and an operating profit (EBITDA) of NOK 603 million in 2008. It is listed on the Oslo Stock Exchange.

 

See www.pronova.com for further information.