SUCCESSFULL PHASE III TRIAL IN JAPAN
(Thomson Reuters ONE) -
10 May 2011, Lysaker, Norway: Pronova BioPharma announced first quarter 2011
revenues of NOK 452 million, down 0.9 per cent year-on-year and 16.3 per cent up
quarter-on-quarter. EBITDA reached NOK 177 million, down 4.2 per cent year-on-
year and 36.1 per cent up quarter-to-quarter. End-user demand in Pronova
BioPharma current eight largest markets, as measured by IMS, grew 14 percent,
pushing the moving annual total volumes to 1 238 tonnes, representing USD 1.3
billion in drug sales, consolidating the position of Pronova BioPharma's
pharmaceutical product as a blockbuster drug. The robust end-user demand was
more than offset by a decision by US marketing partner GSK to bring inventory
levels of Lovaza(TM) in line with end-user demand. The resulting lower shipments
to GSK were compensated for by higher 2011 supply prices, with the revenue-to-
shipment ratio increasing to 1.18 in the first quarter of 2011 compared to 0.97
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.
Pronova BioPharma is continuing its geographical expansion into new markets and
expects to generate sales from these initiatives from 2012. The most important
new market will be Japan, supplemented by a number of new emerging markets which
also represent growth opportunities. Takeda Pharmaceutical Company and Pronova
BioPharma have disclosed top-line results of the pivotal phase III clinical
trial of TAK-085 which included head-to-head study against an EPA product. The
trial met primary end-points and once again demonstrated that Omacor® is a
superior triglyceride lowering and lipid management product.
Pronova BioPharma also has high expectations for its emerging pipeline of new
products which have demonstrated encouraging pre-clinical results. The lead
candidate, PRB-6014, is an entirely newly engineered compound in the
dyslipidemia area. Pronova BioPharma is in the process of submitting a Clinical
Trial Application, an Investigator Brochure and an Investigational Medicinal
Product Brochure to the UK authorities (Medicines and Healthcare products
Regulatory Agency and the ethics committee) and expects to begin clinical
studies at the end of Q2 2011.
Some 21 months post patent expiry in most European countries, no generic entrant
has been observed, demonstrating the high barriers to entry and in particular
the unique strengths of Pronova BioPharma's manufacturing capabilities. In
Italy, the 10-year license and supply agreement with Pronova BioPharma's Italian
partners, which expired in April 2011, was renewed through a multi-year
exclusive supply agreement. The agreement will provide 100 per cent of the total
requirements of Prospa, Sigma Tau and Pfizer in the Italian market. Italy was
the first market where Pronova BioPharma's pharmaceutical product was launched
in 1994 and remains the second largest pharmaceutical market, with continued
double digit growth. Italy continues to be a key market in terms of both size
and growth, as well as the important backing it has received from key opinion
leaders. Data from three large scale trials (the GISSI Prevenzione trial, the
GISSI Heart Failure trial and the ongoing GISSI Risk and Prevenzione trial) have
involved most leading cardiology centres in Italy and have provided important
clinical evidence of the product's cardiac protective effects.
The group reached an agreement with Apotex during the first quarter to settle
patent litigation regarding Apotex's proposed generic version of Lovaza(TM). The
terms of the settlement are confidential, but Apotex has been granted a license
to enter the US market with a generic version of Lovaza(TM) in the first quarter
of 2015 or earlier under certain circumstances. As part of the settlement, the
parties will enter a supply agreement for delivery of Pronova BioPharma's active
pharmaceutical ingredient to Apotex' proposed generic version of Lovaza(TM). The
license and supply agreement with GSK has been amended to allow for potential
generic entry. According to the amendment, Pronova BioPharma will continue,
after generic entry, to provide GSK with its entire requirements of the active
pharmaceutical ingredient and the pricing formula will remain unchanged as long
as GSK is Pronova's exclusive licensee in the US territory. Pronova BioPharma is
currently involved in lawsuits with Teva and Par regarding infringement of the
company's patents relating to Lovaza(TM).
Pronova BioPharma has developed and patented a unique process for removing
environmental pollutants and cholesterol. With the increasing regulatory and
public focus on the harmful effects of environmental pollutants in omega-3 fish
oils, these patents constitute important intellectual property and are a
testament to Pronova BioPharma's dedication to, and investment in, patient
safety. In the US, Europe and Asia, suppliers seeking to enter the
pharmaceutical market as well as established companies in the omega-3
nutritional supplements market, may be infringing these key production process
patents. Pronova BioPharma will vigorously defend its intellectual property and
is currently preparing several enforcement actions in North America, Europe and
Asia.
Pronova BioPharma's Chief Executive Officer Morten Jurs commented, "This was
another strong quarter, with a robust operational performance combined with a
continued increase in demand for Omacor® / Lovaza(TM). A key event in the
quarter was entering into a renewed, exclusive supply agreement with our
existing Italian partners. Italy is Pronova BioPharma's second largest market
and the biggest market in Europe for our products. Moreover, some 21 months
after patent expiry in Europe, we remain the only player in the market,
demonstrating the significant barriers to entry including the need for
substantial upfront investment. In addition to our leading role in our current
markets, we continue to focus on expansion into new territories including Japan
where a very successful 6-year clinical development programme is close to
realisation."
The complete first quarter 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 22 53 48 60
Synne H. Røine, CFO
+ 47 22 53 48 92
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
Pronova BioPharma Q1 2011:
http://hugin.info/137506/R/1513934/449877.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#1513934]
Unternehmensinformation / Kurzprofil:
Datum: 10.05.2011 - 08:01 Uhr
Sprache: Deutsch
News-ID 54445
Anzahl Zeichen: 8221
contact information:
Town:
Lysaker
Kategorie:
Business News
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