Pronova BioPharma ASA: LOTRIGA APPROVED IN JAPAN AND PRC-4016 TO ENTER PHASE II CLINICAL TRIALS
(Thomson Reuters ONE) -
14. November 2012, Lysaker, Norway: Pronova BioPharma today announced results
for the third quarter and first nine months of 2012. Third quarter 2012 revenues
were NOK 427.9 million, up 9 per cent compared with the third quarter of 2011.
Revenues in the first nine months of 2012 were NOK 1 354.6 million, up 10.6 per
cent compared with the same period last year. EBITDA was NOK 208.7 million in
the quarter, representing a 15.9 per cent increase over the same period last
year, and NOK 651.3 million in the first nine months of the year, up 28.2 per
cent from the corresponding period in 2011.
Moving annual total (MAT) end-user demand for Pronova BioPharma's prescription
drug in its current eight largest markets, as measured by IMS, fell 1 per cent
overall. Moving annual total (MAT) volumes were 1 268 tonnes. This represents
USD 1 393 million in drug sales on a MAT basis, up 1 per cent year-on-year,
ensuring that Pronova BioPharma's pharmaceutical product remains a blockbuster.
During the quarter, Pronova BioPharma and its partner in Japan, Takeda
Pharmaceutical Company Limited ("Takeda"), announced that the Japanese Ministry
of Health, Labour and Welfare approved a New Drug Application (NDA) of Lotriga
granular capsule 2g ("Lotriga") for the treatment of hyperlipidemia. Upon
approval, Pronova BioPharma and Takeda are confident that Lotriga will be able
to become a valuable new treatment option for patients in Japan living with
hyperlipidemia. A pricing announcement and launch of the product are expected in
the near term.
Upon approval and launch in Japan, Pronova BioPharma's pharmaceutical product
will be marketed in 61 countries. The launch in Japan, together with recent
approvals in geographies such as in India, Brazil, Argentina and Morocco, forms
a core part of Pronova BioPharma's strategy to promote continued growth in its
pharmaceutical product.
As previously announced, in May the U.S. District Court for the District of
Delaware ruled in Pronova BioPharma's favour in the patent litigation against
Teva and Par, in relation to Lovaza U.S. Patent Nos. 5,656,667 (expiring in
April 2017) and 5,502,077 (expiring in March 2013). Par and Teva have both
appealed the decision to the United States Court of Appeals for the Federal
Circuit, on the issues of infringement, validity and enforceability. A hearing
is expected to take place in 1H 2013.
In Europe, as previously announced several generic companies have obtained
authorisations to market generic versions of Omacor and, since the period end, a
generic version of Omacor has been observed in the UK and Germany. Pronova
BioPharma and its commercial partners have been working closely together to
ensure the continued success of the product in Europe in the evolving
competitive environment. This includes a continuous evaluation of enforcement of
remaining intellectual property rights, as well as, the implementation of
several other measures.
As announced in September, the Spanish public authorities decided to reintroduce
reimbursement for patients with severe hypertriglyceridemia when fibrates are
contraindicated. This is a partial reversal of the decision announced in August
to discontinue reimbursement of Omacor as part of a general measure to reduce
healthcare costs. The reintroduction of reimbursement is an important step in
securing continued access to Omacor for Spanish patients.
The Consumer Healthcare Division was officially launched in November. The
strategy for the Consumer Healthcare Division is based on a number of key
differentiating factors, including the development of innovative products, the
Company's integrated end-to-end value chain, a strong focus on high concentrate
products, the uniqueness of purity by leveraging Pronova BioPharma's
manufacturing expertise and patented environmental pollutant stripping
technology, and commercial partnerships.
Further progress has also been made in developing the clinical nutrition
business. In October, the Clinical Nutrition Division entered into a sponsored
research project with Boston Children's Hospital to investigate new intravenous
clinical nutrition compositions in pre-term infants. The aim of the project is
to study improved lipid composition of fish oil-based Intravenous Fat Emulsions
(IFE's), which are nutritional supplements given to patients unable to absorb
adequate nutrition orally or enterally due to medical conditions such as Short
Bowel Syndrome (SBS). Long term use of conventional IFE's, based on soybean
oils, can cause severe complications such as Parenteral Nutrition Associated
Liver Disease (PNALD), which can result in severe morbidity and death. In 2003,
researchers from Boston Children's hospital identified that fish oil-based IFE
was effective in preventing and even reversing PNALD in patients receiving
parenteral nutrition. Pronova BioPharma and Boston Children's Hospital are
investigating the development of a fish oil-based IFE.
Pronova BioPharma's large phase I study of PRC-4016 will be finalized during Q4
2012. Results have so far been very encouraging with no drug related side
effects seen. The Group expects to move directly into Phase II clinical trials
in the fourth quarter of 2012.
Pronova BioPharma maintains its outlook for 2012 of revenue and EBITDA growth,
with the strongest growth having come in the first half year. Shipments in 2012
and 2013 are expected to be aligned with underlying end-user demand and launches
in new growth markets. The 2012 and 2013 revenue-to-shipment ratio is
anticipated to be between 1.10 and 1.20.
The main risk to the Company's guidance relates to the loss of market
exclusivity and that economic pressures and weak public finances could affect
volume and price development in selected pharmaceutical markets.
Pronova BioPharma's Chief Executive Officer Morten Jurs commented, "We continue
to deliver strong financial results and our strategic projects have successfully
reached important milestones. Last week we officially launched our consumer
healthcare business and are about to launch Lotriga in Japan. In addition, we
expect to move our lead pipeline candidate into Phase II clinical trials and
entered into a sponsored research project with Boston Children's Hospital to
investigate new intravenous clinical nutrition compositions in pre-term
infants."
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
Report Q3 2012 Pronova BioPharma:
http://hugin.info/137506/R/1657608/536197.pdf
This announcement is distributed by Thomson Reuters on behalf of
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(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#1657608]
Unternehmensinformation / Kurzprofil:
Datum: 14.11.2012 - 07:31 Uhr
Sprache: Deutsch
News-ID 203139
Anzahl Zeichen: 7987
contact information:
Town:
Lysaker
Kategorie:
Business News
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