Adds another patent to the Orange Book listing of Omacor®/Lovaza(TM)
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:
http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm
"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 7,732,448.
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 cardiovascular segment.
Contact
Morten Jurs, CEO, telephone: (+47) 22 53 49 10, email: morten.jurs@pronova.com
Hamed Brodersen, VP IR and Communications, telephone: (+47) 41 74 11 22, email:
hamed.brodersen@pronova.com
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 Lovaza(TM) in the United
States. The product is manufactured, using a unique and complex process, at the
Company's plants in Sandefjord, Norway and Kalundborg, Denmark.
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.
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 information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1429517]
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Source: Pronova BioPharma ASA via Thomson Reuters ONE
