Pronova BioPharma, the high-dose omega-3 supplier of pharma blockbuster drug Omacor/Lovaza, is moving into the food supplements space with patent expiration looming.
The Norwegian company says it will invest €7.3m in the next 12 months to bring high-dose omega-3 supplements to European and international markets under its just formed Consumer Healthcare division.
The move comes as a method-of-use patent for Omacor/Lovaza expires in 2013, along with a composition patent that expires in 2017. At that point the market can open to generic versions.
Pronova licenses its high-dose omega-3 drug to pharma companies like GlaxoSmithKline, which markets the product as Lovaza in the US, where 65% of $1.25bn, 2010 global sales are accounted for, according to IMS Health.
Lovaza is approved by the Food and Drug Administration (FDA) to treat those with very high triglyceride levels. The drug goes by the name Omacor in Europe. Together the two are sold in 57 countries with other companies licensing the product like Pfizer and Abbott.
Not about the patent
Morten Jurs, Pronova CEO, told NutraIngredients no partners had yet been confirmed with the food supplements project, and therefore no launch market, which “will depend on their strategy”.
Jurs played down the significance of the patent expiration in the decision.
“Omacor has been off-patent in Europe since August 2009 and there is still no generic product on the market so it is not about that. It is part of a diversification strategy and is possible now because of the capacity expansion we engaged in last year so we can produce 2500 tonnes per year. There is 900 tonnes excess we can devote to supplements if we want to.”
Products would have EPA/DHA doses of 60-75% of a 1g pill, meaning 600-750mg per pill.
Pronova BioPharma referenced Global Organisation for EPA and DHA Omega-3s (GOED) data that predicts a food supplements market twice its current size in five years.
The company noted it had invested $500m in its Norwegian and Danish manufacturing facilities and was working on other lipid extractions for pharma and supplement applications.
“The company will spend the next 12 months building the Consumer Healthcare organisation, adjusting the manufacturing processes for consumer products, initiating small clinical trials and developing distribution channels,” it said in a statement.
“The board of Pronova BioPharma believes the potential for continued growth of differentiated, high quality omega-3 supplements supported by clinical data is significant as awareness of their health benefits continues to expand in both developed and emerging markets.”
In a statement Jurs added: ”The combination of aging populations, changing lifestyles and the increasing awareness of the importance of omega-3 in maintaining good health are expected to drive strong growth in both pharmaceutical grade and high quality consumer-focused omega-3 products in the coming years.”
“Having established a dominant position in the omega-3 pharmaceutical market, we are well positioned to leverage our existing infrastructure, knowledge, research, regulatory and partnership capabilities in order to drive a highly successful consumer business targeting a different segment of the population.”
After the US, the biggest markets for Omacor/Lovaza are the US, Italy, the UK, France, Greece, Spain, Germany, and South Korea.