Pronova BioPharma To Expand Manufacturing Capabilities And Double Capacity
Pronova BioPharma ASA ("Pronova BioPharma" or the "Company") recently announced the approval from the board to start construction of a new manufacturing facility to be located in Kalundborg, Denmark. The new facility is expected to double the current production capacity of the active pharmaceutical ingredient ("API") used in Pronova BioPharma's lead product, marketed as Omacor in Europe and Lovaza in the United States. The Company plans to invest between NOK 1.45 billion and NOK 1.7 billion. The expansion project will be funded principally through a multicurrency revolving credit facility of NOK 1.5 billion, and any capital requirements above NOK 1.5 billion are expected to be financed through the company's operations. The project expects construction to commence later this month. The new facility is expected to be operational and approved by the relevant regulatory authorities by the first half of 2010.
Pronova BioPharma has experienced strong growth over the past three years and the need for a second manufacturing site has been driven by continued increases in demand for the Company's API. The company believes the new site is ideally located within the pharmaceutical development cluster in Denmark, and is expected to provide Pronova BioPharma access to highly qualified and skilled employees.
The Kalundborg facility will be based on the same technology as the Company's current facilities in Sandefjord, Norway, and is expected to produce 1,200 tonnes of API annually. This would double the capacity compared to the 1,200 tonnes produced at the existing Sandefjord plant. The Company believes that using the same technology and structure as its Sandefjord plant will help to secure the requisite regulatory approval of the new facility and progress the construction as efficiently as possible.
Tomas Settevik, CEO of Pronova BioPharma, said: "Today's announcement to start construction of a new facility which is expected to double our production capacity by 2010 will enable Pronova BioPharma to continue fast growth and ensure we are well positioned to meet further increases in demand for our API. The new facility will be built in Kalundborg in Denmark and will be ideally located within the Danish pharmaceutical development cluster to attract highly qualified employees to work in what will be our second unique and complex manufacturing plant.
About Pronova BioPharma
Pronova BioPharma (previously Pronova Biocare) is a global leader in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products. Pronova BioPharma's first commercialized product is branded as Omacor in a number of countries throughout Europe and Asia and as Lovaza in the United States. The product is manufactured at the Company's plant in Sandefjord, Norway using a unique and complex process.
Omacor/Lovaza is the first and only EU- and FDA-approved omega-3 derived prescription drug. The drug is prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known as hypertriglyceridemia (HTG), a form of dyslipidemia (or disorder of lipid metabolism). Very high triglycerides have been linked to a number of cardiovascular diseases. Omacor is also approved in key European and certain Asian markets for the secondary prevention of post-myocardial infarction, or Post-MI, the period following the initial survival of a heart attack.
Omacor/Lovaza has been demonstrated in a number of clinical trials to be a potent triglyceride-lowering agent as a monotherapy. It has been documented to be efficacious, safe, and highly complementary to other lipid-lowering agents, such as statins, and can be used in concomitant treatment for mixed dyslipidemia. In addition, Pronova BioPharma is involved in various projects to develop Omacor/Lovaza in a number of cardiovascular indications, including as a combination therapy with statins for mixed dyslipidemia which management believe represents a major market opportunity for the Company.
Pronova BioPharma's global network of license and distribution partners includes: Reliant Pharmaceuticals (US), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others). The combined sales force from this network focused on the sale of Omacor/Lovaza is over 1,750 sales representatives, of which approximately 600 are employed by Reliant Pharmaceuticals in the US.
Omacor/Lovaza was launched in 2005 in the US and in major European markets, such as France and Spain. IMS Health reports that global end-user sales of the product have increased from US$144M in 2005 to US$306M in 2006. The current annual run rate for end-user sales is estimated at US$500M, and the Company estimates that approximately 600,000 patients are currently on a prescription for Omacor/Lovaza.
SOURCE: Pronova BioPharma