Pronova BioPharma receives Lovaza(TM) Paragraph IV Notice Letter from Apotex Inc
(Thomson Reuters ONE) -
26 November, 2010, Lysaker, Norway: Pronova BioPharma ASA (OSE:PRON.OL) today
announces that it and its US marketing partner GlaxoSmithKline Inc. have
received a Paragraph IV Notice Letter dated 23 November 2010 from Apotex Inc
("Apotex").The Letter refers to Apotex' Abbreviated New Drug Application (ANDA)
No 90-973 to the US Food and Drug Administration, by which Apotex has applied
for approval to market a generic version of Lovaza(TM).
Apotex' Notice Letter advises that it intends to market a generic version of
Lovaza(TM) before the expiration of Pronova BioPharma's US Patent No. 7,732,488
('488 patent, entitled "Pharmaceutical Composition Comprising Low Concentrations
of Environmental Pollutants") which was listed in the FDA Orange Book on 2 July
2010. This patent expires in 2025. Apotex' Notice Letter states that, in its
opinion and to the best of its knowledge, the '488 patent is invalid,
unenforceable, and/or will not be infringed by the commercial manufacture, use
or sale of the product described in Apotex' ANDA.
Pronova BioPharma has full confidence in its intellectual property portfolio
protecting Lovaza(TM) and will vigorously defend and enforce its patents.
For further information, please contact:
Synne H Røine, CFO +47 99 22 98 92
Hamed Brodersen, vice president IR and communication +47 40 46 81 10
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1466019]
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Source: Pronova BioPharma ASA via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 26.11.2010 - 09:23 Uhr
Sprache: Deutsch
News-ID 49147
Anzahl Zeichen: 2220
contact information:
Town:
Lysaker
Kategorie:
Business News
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