New lipid-derived programme to enter clinical phase I trial
(Thomson Reuters ONE) -
12 August 2011, Lysaker, Norway: Pronova BioPharma announced second quarter and
first half year results for 2011 with revenues of NOK 380.7 million, down 14.2
per cent, and NOK 832.2 million, down 7.4 per cent respectively, and compared to
the same period last year. EBITDA reached NOK 150.8 million in the quarter, down
15 per cent year-on-year, and NOK 328.2 million in the first half, down 9.5 per
cent. End-user demand in Pronova BioPharma's current eight largest markets, as
measured by IMS, grew 12 per cent, pushing the moving annual total volume to
1 267 tonnes. This represents USD 1 350.9 billion in drug sales, consolidating
the blockbuster status of Pronova BioPharma's pharmaceutical product. The
robust end-user demand and higher prices helped to partly offset a previously
announced decision by US marketing partner GSK to bring inventory levels of
Lovaza(TM) in line with end-user demand, resulting in lower shipments to GSK.
2011 supply prices were higher than in 2010, with the revenue-to-shipment ratio
increasing to 1.15 in the second quarter of 2011 compared to 1.00 in the same
period last year. Pronova BioPharma maintains its outlook for 2011, with volume
off-take in line with underlying end-user demand, tempered by inventory
adjustments in the US market. Supply prices are expected to increase by 10-20
per cent, from 2010 to 2011.
Numerous new derivatives of omega-3 fatty acids have been synthesised by Pronova
BioPharma's scientists and run through extensive tests to identify candidates
with the most promising profile. The lead candidate, PRC-4016, is the first of a
number of new chemical entities to emerge from Pronova BioPharma's research into
omega-3 fatty acid derivatives. A Clinical Trial Application (CTA) has been
submitted to the UK authorities (Medicines and Healthcare products Regulatory
Agency and the ethics committee) to enter PRC-4016 into a Phase I trial.
Pronova BioPharma expects the first subject to be dosed in Q3 2011, and the
results are expected by Q1 2012.
The drug is a structurally modified omega-3 fatty acid. Studies in animal
models have shown potent triglyceride and cholesterol lowering effects. The
clinical profile targets the treatment of cardiovascular and metabolic diseases,
in particular mixed dyslipidemia. Mixed dyslipidemia is one of three main types
of dyslipidemia (an imbalance in the level of blood lipids). Mixed dyslipidemia
is characterised by elevated triglycerides (TG) and low high-density
lipoprotein-cholesterol (HDL-C), with or without raised low-density lipoprotein-
cholesterol (LDL-C). Dyslipidemia has been shown to play an important role in
the development of cardiovascular diseases. The prevalence of dyslipidemia
across the seven largest pharmaceutical markets is estimated at approximately
270 million people with diagnosis rates of approximately 35-40 per cent.
Pronova BioPharma also continued its geographical expansion into new markets.
The company has launched Omacor®/Lovaza(TM) in 56 markets and has, together with
commercial partners, identified a further 30 countries for potential future
launches. Launch in the world's second largest pharmaceutical market, Japan, is
expected in 2013. Demographic developments coupled with westernisation of
lifestyles, wide acceptance of omega-3 pharmaceuticals, excellent phase III
trial results, a strong commercial partner (Takeda) and eight years of market
exclusivity makes Japan a very important geographical expansion prospect. In
addition to this, Pronova BioPharma expects regulatory approval and launch in a
number of fast-growing emerging markets. During the quarter, regulatory approval
was received in Argentina and Macedonia and market launch in Venezuela is
planned for Q3 2011.
Pronova BioPharma continues to defend its intellectual property rights in the US
through lawsuits against Teva and Par regarding infringement of the company's
patents relating to Lovaza(TM). A ruling is expected, at the earliest, in Q4
2011. 24 months post patent expiry in most European markets, no generic entry
has been identified.
Pronova BioPharma's Chief Executive Officer Morten Jurs commented, "Our
strategic objectives are to defend our intellectual property, expand our
manufacturing advantages, increase the growth potential of Omacor® and invest in
R&D to secure future growth. During the quarter, we made further progress in
terms of geographical expansion and development of a new pharmaceutical product
pipeline. We look forward to entering a number of important new growth markets
over the next three years and to starting the clinical phase with our lead
pipeline candidate, PRC-4016, which has been designed to have an optimal profile
in the treatment of dyslipidemia."
The complete second quarter and first half year report is available at
www.newsweb.no and at www.pronova.com. The company will present the results
today at 08:30AM CET/07:30 GMT. The presentation will be webcast live and can be
accessed at www.pronova.com. (Internet explorer web browser needed). Webcast
attendees may send questions electronically during the session.
-- Ends --
For further information, please contact:
Hamed Brodersen, Vice President IR and Communications
+ 47 40 46 81 10
Synne H. Røine, CFO
+ 47 99 22 98 92
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
Pronova BioPharma Q2 2011:
http://hugin.info/137506/R/1538085/469720.pdf
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#1538085]
Unternehmensinformation / Kurzprofil:
Datum: 12.08.2011 - 07:00 Uhr
Sprache: Deutsch
News-ID 57200
Anzahl Zeichen: 6640
contact information:
Town:
Lysaker
Kategorie:
Business News
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