Ruling by the German Federal High Court of Justice
(Thomson Reuters ONE) -
16 April 2010, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) ("Pronova
BioPharma" or the "company") announces that the German Federal High Court of
Justice has dismissed Pronova BioPharma's appeal.
The decision is the result of an appeal against the Federal Patent Court's
ruling from November 2007 which declared the Omacor patent in Germany (patent DE
3926658 C2) invalid. The nullity action was brought by KD Pharma Bexbach GmbH
("KD Pharma") and Institute Biochimique SA ("IBSA").
Neither KD Pharma nor IBSA has launched a generic version of Omacor in Germany
after the patent was nullified in Germany in November 2007 and as the Omacor
patent expired in Europe in August 2009, the ruling will have no commercial
impact for the company.
Morten Jurs, Chief Executive Officer of Pronova BioPharma, commented:
"We are disappointed with the outcome of this ruling. However, as the patent
already has expired in Europe and we have not seen a launch of a generic version
of Omacor in the nine months since patent expiry, we believe that the final
outcome of this litigation will have no material impact."
For further information, please contact:
Hilde Steineger, VP Investor relations and Communications, +47 48 00 42 40
Morten Jurs, CEO, +47 22 53 49 10
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 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 200.
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 US1.1 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.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1404336]
Unternehmensinformation / Kurzprofil:
Datum: 16.04.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 19141
Anzahl Zeichen: 0
contact information:
Town:
Lysaker
Kategorie:
Business News
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