Pronova BioPharma receives Lovaza(TM) Paragraph IV Notice Letter from Endo
(Thomson Reuters ONE) -
14 June 2011, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) ("Pronova
BioPharma" or the "Company") today announces that it and its U.S. marketing
partner GlaxoSmithKline Inc. ("GSK") have 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).
In its Notice Letter, Endo states that it intends to market a generic version of
Lovaza(TM) before the expiration of US Patents Nos. 5,502,077 ('077 patent),
5,656,667 ('667 patent) and 7,732,488 ('488 patent). These patents are listed in
the FDA's Orange Book and expire in 2013, 2017 and 2025 respectively. Endo's
Notice Letter states that its ANDA contains a Paragraph IV Certification
alleging that the '077, '667 and '488 patents are not valid and/or
unenforceable, or will not be infringed by the commercial manufacture, use or
sale of Endo's product.
This is the fourth Paragraph IV Notice Letter Pronova BioPharma and GSK have
receieved. In March 2011, Pronova entered into an agreement with Apotex Corp.
and Apotex Inc. (collectively "Apotex") to settle the patent litigation
regarding Apotex's proposed generic version of Lovaza(TM) (omega-3-acid ethyl
esters).
Pronova BioPharma is currently still involved in lawsuits with Teva
Pharmaceuticals USA, Inc. ("Teva") and Par Pharmaceutical, Inc. ("Par"),
regarding infringement of the company's patents relating to Lovaza(TM).
Pronova has full confidence in its intellectual property portfolio protecting
Lovaza(TM) and will vigorously defend and enforce its patent.
Contact:
Hamed Brodersen,
VP Investor Relations and Communications
Tel: +47 40 46 81 10
This information is subject of the disclosure requirements acc. to §5-12 vphl
(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#1523181]
Unternehmensinformation / Kurzprofil:
Datum: 14.06.2011 - 09:12 Uhr
Sprache: Deutsch
News-ID 55532
Anzahl Zeichen: 2688
contact information:
Town:
Lysaker
Kategorie:
Business News
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