2009-11-25 15:17:03 -
London, November , 25, 2009
25 November 2009, Lysaker: Pronova BioPharma ASA (OSE: PRON.OL) has
received approval from EU regulatory authorities for its new
manufacturing plant in Kalundborg, Denmark, enabling the plant to
start commercial deliveries in the first quarter of 2010, as planned.
The timeline for the approval from the US Food and Drug
Administration remains unchanged and is expected to be received in
the second half of 2010.
"This approval marks one of the last major milestones for the
important and prestigious investment project in Kalundborg. Our new
plant is now recognised by the EU as an approved manufacturer of our
active pharmaceutical ingredient, and we look forward to start the
commercial deliveries to our European partners early in the first
quarter of 2010," says CEO Morten Jurs.
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For further information, please contact:
Morten Jurs, CEO +47 99 16 79 22
Hilde H. Steineger, Vice president of IR and +47 48 00 42 40
communications
About Pronova BioPharma
Pronova BioPharma 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 LovazaTM in the United States. The product is
manufactured at the company's plant in Sandefjord, Norway using a
unique and complex process. A new manufacturing plant in Kalundborg,
Denmark opened on 1 October 2009, which is expected to start
commercial deliveries in the first quarter of 2010.
Omacor®/Lovaza(TM) 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(TM) 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. In
addition, Pronova BioPharma is involved in various projects to
develop Omacor®/Lovaza(TM) 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: GlaxoSmithKline PLC (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(TM) is approximately 2,650 sales representatives.
Omacor®/Lovaza(TM) 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$144
million in 2005 to US$778 million in 2008. The current annual run
rate for end-user sales is estimated at US$953 million (as of
December 2008), and the Company estimates that approximately 750,000
patients are currently on a prescription for Omacor/Lovaza.
Pronova BioPharma had revenues of NOK 1,302 million and EBITDA of NOK
603 million in 2008. The company is listed at Oslo Børs. See
www.pronova.com for more information.
Disclaimer
Certain statements in this release concerning our future growth
prospects are "forward-looking statements", which involve a number of
risks, and uncertainties that could cause actual results to differ
materially from those in such forward-looking statements. The risks
and uncertainties relating to these statements include, but are not
limited to, risks and uncertainties regarding fluctuations in
earnings, our ability to manage growth, intense competition in the
pharmaceutical industry including those factors which may affect our
ability to manufacture our products, our ability to attract and
retain highly skilled professionals, the regulatory environment in
which we operate and unauthorized use of our intellectual property
and general economic conditions affecting our industry. We do not
undertake to update any forward-looking statement that may be made
from time to time by us or on our behalf.
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
