Monday, 25 June 2012

Interview: Hilde Steineger, Vice President of Business Development, Pronova BioPharma

Interview with Hilde Steineger, Vice President of Business Development, Pronova BioPharma

Could you introduce Pronova BioPharma?
Pronova BioPharma is a Scandinavian health care company providing preventive care and life-saving treatments focused on safe and efficacious lipid therapies. We are a leader in omega-3s, and have helped to shape the industry through pioneering drug discovery, development of complex manufacturing processing and innovative commercialisation models. Today, our products help improve the lives of 1.4 million heart patients in 57 countries.

Can you tell us about your products?
We have developed the first and only omega-3 derived prescription drug approved by the European regulatory authorities and the U.S. Food and Drug Administration (FDA).

The drug, which is branded through a network of commercial partners and sold in 57 countries under the brand names Lovaza, Omacor®, Zodin®, Seacor®, Escapent® and Eskim®, has become a blockbuster product with USD 1.4 billion in sales in the 8 largest markets. It is used as an adjunct to diet and other lifestyle changes for the treatment of elevated levels of triglycerides, which have been linked to cardiovascular diseases and are included in the American Heart Association, European and Asian treatment guidelines. The drug has also been approved in several European and Asian markets for the secondary prevention of post-myocardial infarction in the period following the initial survival of a heart attack.

In line with our mission to maintain and further develop our global leadership in lipid-derived health-bringing products, we are engaging in significant Research & Development to create new patent protected lipid derivatives for the treatment of cardiovascular, metabolic and inflammatory diseases.

We are also collaborating with leading scientists and commercial partners to develop new clinical nutrition products which will provide omega-3 nutrition for ill patients.

Pronova BioPharma is also developing high quality omega-3 consumer health supplements with documented health benefits. The strong body of clinical data that has driven the success of our pharmaceutical business has greatly increased consumer awareness of the benefits of high grade omega-3 supplements. We believe that our ability to manufacture high concentrate, high purity omega-3 supplements will be a key differentiator in delivering purer, more efficacious products for the consumer than what’s currently available.

You have mentioned purity a number of times. Can you talk a bit about the issue of purity in omega-3s?
The raw material fish oil that is used for the processing of omega-3 products may contain various amounts of environmental pollutants, which were present in the fish from which the oils were derived. Basically, concentrating fish oils in order to develop concentrated omega-3s could also have the effect of concentrating the environmental pollutants and oxidation products, unless you take steps to remove these harmful products. High levels of environmental pollutants and oxidation products may pose a risk to human health.

We believe that this issue has contributed to an interesting “trust paradox” in the consumer omega-3 supplement market. On one hand, omega-3 is highly researched, with more than 2,100 clinical studies published and a vast number of articles on the subject. On the other hand, the category arguably has some issues around trust because of the variable quality and marketing around these products – leading to concerns among consumers about what and whom to trust.

So the challenge for the industry, in our view, is how to increase consumer awareness of and demand for both efficacy and safety?

We believe that Pronova BioPharma is ideally positioned to address this challenge and take advantage of the growing opportunity it presents. Our leadership position in pharmaceutical omega-3s and clinical evidence base enables us to clearly demonstrate proven efficacy. Likewise, Pronova BioPharma has developed a complex manufacturing chain which involves patented environmental pollutant-stripping processes and the use of an antioxidant, to achieve very high levels of purity for our products.

So what’s the future for Pronova BioPharma?
There are many opportunities for growth for Pronova BioPharma. We have a strong franchise of branded products that have been clinically proven to be efficacious and safe. We will continue to manage the life cycle of these products in existing markets at the same time as we expand our geographical reach. From our strong base we will expand our business into diverse but related areas where we can leverage our core capabilities, such as omega-3 consumer health care and clinical nutrition. We are also pursuing long-term clinical research and development into lipid derived therapies for the treatment of metabolic, cardiovascular and inflammatory diseases.
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