November 14, 2012 at 01:30 AM EST
Pronova BioPharma ASA: LOTRIGA APPROVED IN JAPAN AND PRC-4016 TO ENTER PHASE II CLINICAL TRIALS

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)



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Source: Pronova BioPharma ASA via Thomson Reuters ONE

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