Pronova BioPharma ASA : Generic marketing authorisation in the UK
(Thomson Reuters ONE) -
Lysaker, Norway, 20 April 2012: Pronova BioPharma ASA today announced that Teva
UK Limited has obtained authorisation to market a generic version of a 1 gram
soft capsule omega-3 acid ethyl esther in the United Kingdom.
The composition patent covering Omacor in most European territories expired in
August 2009. This is the first known marketing authorisation of a generic
pharmaceutical product based on Pronova's active pharmaceutical ingredient
(API). Pronova is not aware of the generic product having been launched in
Europe.
Teva has used the UK as the reference member state (RMS) in either a mutual
recognition procedure (MRP) or a decentralised process (DCP) to also apply for
marketing authorisation in the following concerned member states (CMS): Austria,
France, Italy, Netherlands, Germany, Ireland, Romania and Spain.
Pronova's CEO Morten Jurs commented: "As previously indicated, we have been both
closely monitoring and preparing for the possibility of losing exclusivity since
patent expiry in 2009. We will continue to monitor the situation as it evolves
and, together with our commercial partners, act to reposition ourselves in the
new competitive landscape."
About Pronova BioPharma
Pronova is a global leader in research, development and manufacture of lipid
therapies derived from nature.
The group's first commercialised product, Omacor/Lovaza, is branded in a number
of countries (57) throughout Europe, Asia and in the USA. End-user sales has
grown rapidly in all international markets and the annual run rate at 31
December 2011 reached USD 1 380 million, according to IMS Health. The product is
the first EU- and FDA-approved omega 3-derived prescription drug.
Marketing and distribution of Pronova's key product is currently licensed to
both local and global pharmaceutical companies.
The company is in the process of developing several new, patentable lipid
derivatives. The most advanced lipid derived pharmaceutical programme is in the
area of combined dyslipidemia, the abnormal concentration of lipids and
lipoproteins in the blood, for which the company has a product, PRC-4016, in
clinical trials.
Pronova has also announced plans to enter the consumer healthcare and clinical
nutrition markets, enabling the company to further leverage its position as the
world's largest manufacturer of high grade omega-3 derived products.
Pronova's headquarters are located at Lysaker in Norway, while production takes
place at state-of-the-art manufacturing facilities at Sandefjord in Norway and
in Kalundborg, Denmark. The company's shares are listed on Oslo Børs with the
ticker code PRON.
Additional information is available on www.pronova.com.
For further information contact:
Hamed Brodersen, VP Investor Relations and Communications
Tel: +47 40 46 81 10
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#1604381]
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 20.04.2012 - 02:01 Uhr
Sprache: Deutsch
News-ID 1105376
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
Lysaker
Phone:
Kategorie:
Business News
Anmerkungen:
Diese Pressemitteilung wurde bisher 88 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Pronova BioPharma ASA : Generic marketing authorisation in the UK
"
steht unter der journalistisch-redaktionellen Verantwortung von
Pronova BioPharma ASA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
