Neptune technologies & bioressources discovering buried treasure.(COMPANIES TO WATCH) - Nutraceuticals World

Neptune technologies & bioressources discovering buried treasure.(COMPANIES TO WATCH) - Nutraceuticals World

Almost two decades have passed since Neptune president and CEO Henri Harland stumbled upon a new business venture involving a tiny organism from the sea called krill. Through many years of work on the krill research project, he was able to learn a lot about the nutritional profile of this creature. Mr. Harland envisioned that if these tiny organisms could feed whales and survive on the bottom of the ocean, then there had to be something special about them.

Mr. Harland's search for krill began at the St. Lawrence River in the mid-1990s. The adventure prompted him to seek out a laboratory that could help him evaluate the nutritional profile of krill and develop an extraction process. 'We knew early on that we didn't want to work with Pacific krill because the contaminants were very high and the nutritional profile was inadequate. We wound up evaluating krill from all over the world just to find the right species,' said Tina Sampalis, MD, PhD, CSO. 'We finally found what we were looking for in the South Antarctic Ocean, in the designated Zone 48.'

Dr. Sampalis claims Zone 48 is the cleanest and purest environment for krill in the world. It also happens to produce the krill with the best nutrient profile. Also important, Zone 48 is strictly controlled from an environmental perspective, so there is always someone keeping tabs on who can fish there, with what method, and how much they can take home.

Neptune as a company was incorporated in 1998. It didn't immediately have product available for the market because its first priority was establishing a scientific basis for the unique ingredient complex it branded Neptune Krill Oil, or NKO. 'We didn't want to sell a drop of oil before we confirmed safety and efficacy,' Dr. Sampalis said.

By 2000, the company had enough material to initiate clinical trials. So far it has completed phase I, II and IIIa studies, proving NKO's safety and effects in reducing the risk of cardiovascular events. NKO has also been subjected to a battery of tests to assess purity, stability and shelf life.

Neptune has spent a lot of time shoring up its patent protection and gaining the necessary regulatory approvals around the globe. In fact, NKO has been issued 'composition of matter' patents in 24 countries in Europe.

On the food side, while Neptune awaits novel foods approval in Europe, it is taking advantage of the recently granted Generally Recognized as Safe (GRAS) status in the U.S. for NKO--both of these safety designations are difficult and tedious to attain. All of this work--preclinical/clinical research, toxicology, creating and commercializing the production process-has cost the company approximately $22 million, according to Dr. Sampalis. 'From the very beginning we wanted to make certain we had our intellectual property in place so no one could touch us,' she said. 'Even if today our intellectual property is airtight, we recognize that protecting IP is a rigorous, dynamic process that we are dedicated to.'

At the heart of Neptune's operations, of course, is NKO and its unique nutrient profile. NKO is an oil mainly comprised of phospholipids, which function as carriers for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). NKO also contains a fair amount of astaxanthin, which serves as its natural antioxidant protector, giving it a three-year shelf life.

In the short term, Neptune's goal is to firmly establish itself in the dietary supplement and functional food markets. With regard to the latter, it has already signed research collaborations with Yoplait and Nestle, which Dr. Sampalis says will eventually result in commercial food and beverage products containing NKO.

After receiving its GRAS notification in January, Neptune voluntarily submitted the assessment document to FDA. With this regulatory clearance for commercialization in food in the U.S., Neptune expects to enter additional food partnerships in the future. 'NKO is such a good candidate for functional foods because we've already successfully completed studies of NKO proving significant effects at low dosage levels,' Dr. Sampalis explained. 'This is of great benefit for any food or beverage company that wants to comply with the strict EFSA (European Food Safety Authority) and upcoming FDA rules for functional food label claims.'

On the supplement side, Schiff Nutrition is distributing NKO under the brand name Schiff MegaRed, which promotes cardiovascular and joint health. Schiff MegaRed is currently available in a 300 mg dosage form at nationwide Costco locations in the U.S. Soon it will be available at worldwide locations as well. Also, certain national NKO distributors in Europe have successfully received country-based approval for labeling and commercialization of NKO as a dietary supplement, namely in Sweden, Austria and France.

Lastly, Neptune recently entered into an alliance with Croda Health Care, an omega 3 player that has already launched five 'Essentially' products in the U.S. and Europe.

According to Dr. Sampalis, Neptune has a rich pipeline of products at different stages of development, in preparation for the company's entrance into the pharmaceutical sector. In that regard, Neptune recently obtained complementary medicine approval in Australia and New Zealand. In fact, Invida Pharmaceuticals, the holding company of PharmaLink and Inovail--an independently managed specialty pharmaceutical company--has successfully entered the market with Omega-Gen containing NKO. Neptune expects other strategic partners in the future.

Having spent many years in the nutraceuticals business, Dr. Sampalis has learned a lot of lessons. Her advice to other companies is to treat their nutraceuticals as if they were drugs.'A lot of companies think they don't need to bother with toxicity and safety studies. Instead, most of them are interested in making fast money,' she commented. 'The only reason we have been successful is because we've spent a lot of time and money to research every aspect of this product as if it were a drug. For those that have followed Neptune's story, they know the best is yet to come.'

Analysis: Future Issues to Consider

* Neptune could face some uncertainty from the consumer regarding the issue of contaminants, even though its source represents purity levels unseen in the nutraceuticals industry. Unfortunately, consumers may not see it that way, especially since krill comes from the same place as fish, which continues to struggle with perception issues.

* Despite its best efforts, Neptune could also face some indirect backlash as consumers start to worry about the environmental impact of fishing for krill, particularly as other players enter the market.

* Neptune's fate in foods seems tied to its success with Yoplait and Nestle. What might happen to future prospective relationships should the Yoplait/Nestle collaborations fail to produce finished products?

--Rebecca Wright, Editor