HerbalEGram: Volume 6, Number 2, February 2009
After Another Canceled Partnership, the Future of Hoodia Remains Unclear
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Originally used to help calm the hunger pains of the indigenous San people of southern Africa, the appetite-suppressing succulent Hoodia gordonii* has been heralded for several years as the future of weight-loss products.2 A few factors have made this a challenging prospect, including the plant’s slow growth rate and declining availability,3 and reports that many dietary supplements claiming to contain Hoodia do not.4
This has not deterred some large companies, however, from trying to develop authentic Hoodia gordonii-based products for the mass market, including Unilever (Rotterdam, Netherlands), a global manufacturer of food, home care, and personal care products. In 2004 Unilever teamed up with Phytopharm (Godmanchester, United Kingdom), the pharmaceutical and functional food company that holds the patent on an appetite-suppressing Hoodia gordonii compound, which is an oxypregnane steroidal glycoside named P57.5 Unilever had plans to develop a Hoodia gordonii-based product for its line of Slim Fast® beverages and by mid-2008, pre-clinical studies had been completed and clinical studies were under way.6 Submission to the US Food and Drug Administration for generally recognized as safe (GRAS) status was predicted for late 2009 for the use of Hoodia gordonii preparations as an additive in foods and beverages.
These anticipations soon changed when Unilever’s research concluded that the Hoodia gordonii extract failed to meet the company’s high standards for safety and efficacy, leading Unilever to terminate the agreement with Phytopharm in November.5 According to Unilever spokesperson Trevor Gorin, a recent clinical trial carried out by Unilever and Phytopharm on a prototype drink product containing Hoodia gordonii extract showed adverse effects and tolerability issues (D. Mastrojohn, e-mail, January 22, 2009).
“[Unilever] is naturally disappointed, but the project was only viable if we could produce a Unilever branded product which met the standards our consumers expect, and in this case, we did not think it possible,” he said. Unilever reportedly invested about $40 million in the project.5
This makes the second failed Phytopharm partnership to develop a weight-loss product based on the Hoodia gordonii extract. The company previously attempted a partnership with Pfizer (New York, NY), the world's largest biomedical and pharmaceutical company, which canceled its Hoodia gordonii project in 2003. Up to that time, Pfizer was researching the possibility of producing a weight-loss drug from Hoodia gordonii, in contrast to Unilever’s attempts to make a food product. Phytopharm’s stock price fell 30% upon news of the canceled partnership with Unilever, after which the company’s CEO and CFO resigned.
“Although it is disappointing that the collaboration with Unilever on hoodia did not reach a successful conclusion, we are pleased to have agreed termination terms with Unilever which enable us to take the product forward with another partner,” said Phytopharm chairman Alistair Taylor in December 2008.7 Taylor added that Phytopharm continues to believe strongly in the commercialization of Hoodia gordonii and that it will seek potential partners in the areas of functional foods and veterinary and orphan pharmaceutical products (drugs intended to treat diseases or conditions that affect only a relatively few people, thereby making their projected sales revenues relatively small compared to those of drugs for more widespread diseases). This allows drug companies to bypass various regulatory requirements routinely required for most new drugs.
Currently, Unilever and Phytopharm are in a transition stage in which the original patents, rights, and Hoodia gordonii inventories are reverting to Phytopharm. Unilever also gave Phytopharm a non-exclusive, irrevocable, royalty-free license, with the right to sub-license, to any Unilever patents and intellectual property rights connected with the Hoodia gordonii research program. Unilever handed over the responsibility of funding all costs of the Hoodia gordonii program to Phytopharm on January 1.
Many details of the canceled agreement have not been disclosed and remain somewhat unclear. Mathias Schmidt, PhD, of HerbResearch in Germany speculates that 2 forces may have led to the cancellation: toxicity issues with the P57 extract, and problems with cultivated Hoodia gordonii material (e-mail, January 19, 2009).
According to Dr. Schmidt, the Hoodia gordonii plant itself, or when in the form of pressed juice or powder, can be expected to be safe. But, as often is the case, when a specific fraction or a purified constituent is isolated, such as the highly-touted P57, issues can arise. This was seen in data from preliminary experiments of the Phytopharm patent.8
Dr. Schmidt further stated that because the plant has been over-harvested and is nearing extinction in its native range in southern Africa, it is protected from wild-harvest, and all exports and imports are required to have originated from a cultivated plant (e-mail, January 19, 2009). This isn’t the problem, he said, because the actual cultivation process of Hoodia gordonii is quite easy.
“However, the cultivated plant material is not of the same quality as the wild crafted plants, especially when triterpene levels are compared,” Dr. Schmidt said, adding that though P57 has long been thought to contribute to the overall appetite-suppressing effect of Hoodia gordonii, other related steroidal triterpenes also contribute to the overall effect.
“Within a partnership with HerbResearch, the French specialist for medicinal plant selection and cultivation Medicinal and Aromatic Plants R&D has a project running in South Africa where we compare the effect of different growth conditions on the yield of triterpenes, and with our results in mind, we think Unilever might have had problems isolating sufficient quantities of this phytochemical.”
Dr. Schmidt explained that the triterpenes are responsible for Hoodia gordonii’s bitter flavor, which protects the slow-growing plant from being eaten by wild animals or damaged by insects. When Hoodia gordonii is cultivated and given ample supplies of water, however, it grows rapidly and has a decreased need to defend itself, which in turn lowers the need for high production of the foul-tasting triterpenes. Therefore, said Schmidt, the usual practice of Hoodia gordonii cultivation leads to plant material with very low levels of triterpenes. This may also result in a more agreeable flavor, but will make the plants less efficacious as an appetite suppressant.
Though the partnership cancellation disappointed Unilever and Phytopharm, the setback in Hoodia gordonii commercialization also affects the San people of southern Africa. When Phytopharm received the patent on Hoodia gordonii’s P57 component, various reports stated that the San had become victims of biopiracy because the company used their traditional information and shared knowledge without paying them any royalties.9 However, the Council for Scientific and Industrial Research (CSIR), which granted the patent to Phytopharm, later agreed to pay the South African San Council 6% of royalties from the sale of Hoodia gordonii-containing products and 8% of all milestone payments that CSIR receives from Phytopharm.
In regards to the Unilever/Phytopharm partnership cancellation, the San’s attorney, Roger Chennells, said, “The San were certainly surprised, as they know that the hoodia has the properties that have been patented, and expected Unilever to go all the way to the market. Disappointment is also naturally present, as the San expected their first royalties within two or so years. The San leadership however has met and discussed the situation in the light of the positive attitude of Phytopharm to continue to develop the patent, and has every reason to believe that the benefits are simply delayed, rather than terminated” (R. Chennells, e-mail, January 31, 2009).
—Lindsay Stafford
* Because other species in the genus Hoodia sometimes may be sold in commerce as Hoodia gordonii, in February 2007 the American Herbal Products Association adopted a trade recommendation that the standardized common name for this species should be “Hoodia gordonii.”11
References
1. Hoodia Factfile. Phytopharm Web site. Available at: http://www.phytopharm.co.uk/hoodiafactfile/. Accessed January 21, 2009.
2. Leung R. African plant may help fight fat. CBS News. November 21, 2004. Available at: http://www.cbsnews.com/stories/2004/11/18/60minutes/main656458.shtml. Accessed January 21, 2009.
3. Hoodia gordonii (MASSON) SWEET ex DECNE. HERBresearch Germany Web site. Available at: http://www.herbresearch.de/en/arzneipflanzen_hoodia.html. Accessed January 21, 2009.
4. Bogus raw material tarnishes hoodia’s equity, but committed report strong sales. Nutrition Business Journal. September 1, 2007. Available at: http://subscribers.nutritionbusinessjournal.com/ingredient-supply/bogus_material_tarnishes_hoodia/index.html. Accessed on January 29, 2009.
5. Unilever axes plans for a hoodia functional food offering. Nutrition Business Journal. November 18, 2008. Available at: http://nutritionbusinessjournal.com/healthy-foods/news/11-18-unilever-plans-hoodia-functional-food-offering-axe/. Accessed January 21, 2009.
6. Phytopharm. Phytopharm plc Interim Report 2008. Available at: http://www.phytopharm.co.uk/news/newsreleases/?id=8391. Accessed January 26, 2009.
7. Unilever returns rights to Hoodia extract [press release]. Godmanchester, United Kingdom: Phytopharm; December 12, 2008.
8. Schmidt M, Betti G. Hoodia gordonii: safety issues. June 22, 2006. [Unpublished.]
9. Wynberg R. Rhetoric, realism and benefit sharing: use of traditional knowledge of hoodia species in the development of an appetite suppressant. The Journal of World Intellectual Property. 2004;7(6):851-876. Available at: http://www.biowatch.org.za/main.asp?include=pubs/wjip.html. Accessed on January 29, 2009.
10. Kahn T. Unilever dumps plans for hoodia diet pill. Business Day. December 22, 2008. Available at: http://www.businessday.co.za/articles/national.aspx?ID=BD4A909000. Accessed January 21, 2009.
11. AHPA adopts labeling standards for Hoodia gordonii. American Herbal Products Association News Room Web site. February 22, 2006. Available at: http://www.ahpa.org/Default.aspx?tabid=69&aId=256. Accessed on February 3, 2009. |
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