The hunt for innovative ingredients and products capable of enhancing human function and chemistry has taken a front seat role within many dietary supplement and human function-modifying foods- ("functional foods") focused companies. Long gone are the days of introducing a new ingredient simply because animal studies showed it worked when injected (cholecystokinin; CCK), because it "may" occur in a plant and the "real thing" is bioactive (DHEA and Mexican yam) or it has a "great story" but rings hollow on the science side (plant antioxidant enzyme concentrates). Yes, these all did sell-but for a short time. They are virtually extinct today.
With very few exceptions product life cycles have been compressed into a period of 18 months or so. Product duplication (or valiant attempts thereto) has become a blur, arising within a month or less of rollout. This may have fostered the impetus for patent in-licensing (glucosamine sulfate, MSM, chondroitin + glucosamine sulfate, chromium picolinate). However, a patent does not mean POTENT and does not an infringement-free market make. Too many patents have been licensed and not offensively enforced.
The management of innovation and knowledge capital has taken on a level of prominence not dissimilar from that of cash flow and supply chain management. Intellectual capital, in the form of brainpower, both integrated within a company and through a strategic horizontal network, is the new ride at the amusement park, with lines expected to persist for a long time. Being or knowing the person at the front of the line can translate into a very lucrative position.
The focus of this column will be to provide insights and windows into the dynamic world of innovation, with a scientific research and intellectual property (IP) slant. Clinical and pre-clinical studies, both in developmental and ongoing stages, will be highlighted, along with new data BEFORE it gets inserted into the press release extruder machine. Moreover, promising new applications of technology, from novel processing advances to new uses of "old veterans" to "new to the world" biomolecules that fit into the DSHEA equation of a dietary supplement or a truly functional, consumer benefit-rich food (beyond "enriched/fortified" and "herbal blend" fairy tales) will also be included. Research data and IP are delightful trophies to admire and boast around but are essentially worthless if they cannot be successfully commercialized and sustained. This column will be keenly aware of both the thick top and the thin bottom line. Let's dive into this month's inaugural column.
Five Finger Stretch
Carpal tunnel syndrome (CTS) affects about one out of every 1000 in the general population, but as many as 15% of workers in high-risk industries, such as electronic parts assemblers, musicians, meat packers and dental hygienists. Other factors, such as diabetes, rheumatoid arthritis, thyroid disease and pregnancy may be even more important. A recent study from Sweden found one in every five persons with numbness, pain or tingling in the hands to have CTS (JAMA, 1999). However, treatment usually begins and ends with surgery, which offers less than a 100% success rate. Vitamin B6 has long been advocated but it has not withstood rigorous scientific scrutiny. Through the magic of serendipity a new player has emerged on the CTS therapeutic front: the carotenoid astaxanthin.
The lucky party filing the patent is Cyanotech, a publicly traded company based in the harsh and intolerable conditions unique to Kona, Hawaii. Cyanotech has aquaculture as its core technology, turning green algae into green currency. Cyanotech is planning a proof of concept/patent validation clinical trial with its own astaxanthin product among CTS patients, slated to begin this year.
Chemically, astaxanthin shares kinship with lycopene, another red carotenoid. Our primary familiarity with astaxanthin is through its use as a natural colorant for "farm raised" salmon and trout, imparting the fleshy pink color that elicits the subconscious judgement of "fresh" and "tasty" when browsing through the local seafood counter. Supplying commercial fish farms is a big business all alone. Hoffman-LaRoche has a firm hold on this application and has recently introduced its synthetic version of astaxanthin positioned for dietary supplement manufacturers.
Natural source astaxanthin can be extracted from green microalgae (Haematococcus species; it turns brilliant, astaxanthin red when properly coaxed) or a yeast (Phaffia species). Numerous multinational food and pharma companies have filed (and been issued) patents for production of this carotenoid. More interesting is the nature of the utility patents filed: anti-inflammatory, endurance-promoting and even anti-ulcer applications (astaxanthin appears to exert a positive effect against the bacterium associated with stomach ulcers, Helicobacter pylori). Animal studies presented at last year's American Society for Microbiology meetings found astaxanthin to have a profound effect upon the immune system and the amount of H. pylori found within the stomach. Their findings were just published this March in the journal Immunology Letters.
With the new revolution in carotenoids (lutein, astaxanthin, zeaxanthin) and the feverish pace of research driving the market, the "therapeutically suspect" color unique to beta-carotene may be painted over by the rich reds found in astaxanthin. If astaxanthin does indeed demonstrate efficacy for CTS and/or H. pylori infections, the dietary supplement world may undergo a new wave of category creation, addressing demographically rich conditions where surgery or drug therapy is the primary, research-validated recourse.
NW
