Update on U.S. litigation
(Thomson Reuters ONE) -
25 July 2011, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) ("Pronova
BioPharma") announces today that Pronova BioPharma Norge AS and Teva
Pharmaceuticals USA, Inc. have mutually agreed to dismiss the patent litigation
in the United States District Court for the District of Delaware pertaining to
Pronova BioPharma's U.S. Patent No. 7,732,488 (entitled "Pharmaceutical
Composition Comprising Low Concentrations of Environmental Pollutants"), U.S.
Patent No. 7,678,930 (entitled "Process for Decreasing the Amount of Cholesterol
in a Marine Oil Using a Volatile Working Fluid"), and U.S. Patent No. 7,718,698
(entitled "Process for Decreasing Environmental Pollutants in an Oil or a Fat").
Pronova BioPharma is currently still involved in lawsuits with Teva, with regard
to infringement of the Company's U.S. Patents Nos. 5,502,077 (the '077 Patent)
and 5,656,667 ('667 Patent) relating to Lovaza(TM). The trial was held in
March/April this year and a ruling is expected in Q4 2011.
14 June 2011, Pronova BioPharma announced that it and its U.S. marketing partner
GlaxoSmithKline Inc. ("GSK") had received a Paragraph IV Notice Letter from Endo
Pharmaceuticals ("Endo") advising that Endo has submitted an Abbreviated New
Drug Application (ANDA) to the US Food and Drug Administration (FDA) for
approval to market a generic version of Lovaza(TM). Pronova has chosen at this
time to not assert its patents against Endo awaiting the ruling in the
litigation in United States District Court for the District of Delaware
regarding the '077 Patent and '667 Patent against Teva and Par
For further information, please contact:
Synne H. Røine, CFO
+ 47 22 53 48 92
Morten Jurs, CEO
+ 47 22 53 49 10
----------ends------------
About Pronova BioPharma
Pronova BioPharma is a global leader in research, development and manufacture of
lipid therapies derived from nature.
Omacor®, also known as Lovaza(TM) in the US market, and Zodin®, Seacor®,
Esapent®, and Eskim® elsewhere, is the first commercialised product developed
from Pronova BioPharma's active pharmaceutical ingredient (API).
It is also the first and only EU and U.S. FDA-approved Omega 3-derived
prescription drug. Pronova BioPharma estimates that 1.4 million cardiovascular
patients, with high elevated levels of triglycerides and/or having suffered a
heart attack, are currently on a prescription for one of the branded products
containing its API.
Marketing and distribution of Pronova BioPharma's key product is currently
licensed to both local and global pharmaceutical companies. In 2009, the product
reached blockbuster status with sales over USD 1 billion in the current 8 major
markets and in 2010 it grew a further 19 percent to USD 1 260 million in 2010,
according to IMS Health. It is currently marketed in 56 countries with potential
launch in a further 30 countries.
Pronova BioPharma is developing several new, patentable lipid derivatives. The
most advanced Lipid Derived Pharmaceutical programme is in the area of
dyslipidemia, the abnormal concentration of lipids or lipoproteins in the
blood.
Pronova BioPharma's headquarters are located at Lysaker in Norway, while
production takes place in manufacturing facilities at Sandefjord in Norway and
in Kalundborg, Denmark. The company's shares are listed on Oslo Børs with the
ticker code PRON.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Pronova BioPharma ASA via Thomson Reuters ONE
[HUG#1533053]
Unternehmensinformation / Kurzprofil:
Datum: 25.07.2011 - 08:00 Uhr
Sprache: Deutsch
News-ID 56661
Anzahl Zeichen: 4461
contact information:
Town:
Lysaker
Kategorie:
Business News
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