5 July 2010, Lysaker: Pronova BioPharma ASA’s (OSE: PRON.OL) newly issued U.S. Patent
No. 7,732,488 was listed on 2 July in the Orange Book. This is the 4th patent, emanating
from Pronova BioPharma’s pioneering research on essential fatty acids, to be listed by
the U.S. Food and Drug Administration – an achievement which further solidifies Pronova
BioPharma’s position as the first and only company with an EU and FDA approved Omega-3
derived prescription drug.
The new patent is entitled “Pharmaceutical composition comprising low concentration of
environmental pollutants.” The listing of Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly known as the Orange Book, identifies drug products
approved on the basis of safety and effectiveness, and may be viewed on FDA’s website:
“I am proud that Pronova BioPharma through our process development efforts has been able
to develop a technology which removes environmental pollutants and thereby sets a new
industry standard towards reductions of environmental pollutants in Omega-3s. Pronova
BioPharma’s technology and the newly listed composition patent ensure that our
blockbuster drug Omacor/Lovaza(TM) is available for million of patients with very low
concentrations of pollutants” says CEO and President of Pronova BioPharma, Morten Jurs.
Pronova BioPharma’s patents, currently listed in the Orange Book, directed to
Omacor/Lovaza(TM) include: U.S. Patent Nos. 5,656,667, 5,502,077, and the newly listed
Additionally, the U.S. Patent and Trademark Office recently granted two process patents
related to removing environmental pollutants and cholesterol (i.e., U.S. Patent Nos.
7,678,940 and 7,718,698). Pronova BioPharma’s unique and complex stripping technology
reduces environmental pollutants and cholesterol from oils irrespective of the quality
of oil. Omacor/Lovaza(TM) is one of the safest pharmaceutical drugs in the
Morten Jurs, CEO, telephone: (+47) 22 53 49 10, email: email@example.com
Hamed Brodersen, VP IR and Communications, telephone: (+47) 41 74 11 22, email:
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, using a
unique and complex process, at the Company’s plants in Sandefjord, Norway and
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 USD144 million in 2005 to USD 1.1 billion in 2009.
Pronova BioPharma had revenues of NOK 1,790 million and EBITDA of NOK 823 million in
2009. The company is listed at Oslo Børs. See www.pronova.com for more information.
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 information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian
Securities Trading Act)