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Phytopharm Returns Hoodia Gordonii Rights to South African R&D Company

ISSUE:
Page:
21-22

Just months after affirming its continued dedication to bringing a Hoodia gordonii-based product to market,1 UK-based Phytopharm has dropped the South African succulent from its research portfolio.2 In a November 2010 decision, the company returned all development and commercialization rights to South Africa's Council for Scientific and Industrial Research (CSIR).

From 1998, Phytopharm had been leasing an exclusive H. gordonii (Asclepiadaceae) patent from CSIR, one of Africa’s leading research and development institutions.3 Under this contract, Phytopharm had the rights to isolate, extract, and synthesize an appetite-suppressing H. gordonii compound—the oxypregnane steroidal glycoside named P57—on which CSIR originated the patent in 1995.2,3,4

But this ended with Phytopharm and CSIR’s recent cooperation agreement, which states that P57’s commercialization process will now “be led by CSIR in collaboration with national and regional stakeholders.”5 In exchange for sharing its development, agriculture/horticulture, and regulatory expertise with CSIR, Phytopharm will receive an undisclosed amount of whatever profits CSIR might generate from P57 (J. Dineen, e-mail, February 17, 2011). It will not be involved in any further research activities.

Phytopharm’s CEO has told the media that the company’s decision was based on a “corporate decision to exit the functional foods business.” This shift decreases the company’s focus on plant-based ingredients and products and increases focus on its pharmaceutical portfolio, particularly Cogane™, a product being studied for the treatment of Parkinson’s Disease.

“Since the termination of the agreement with Unilever,” said company spokesperson John Dineen, “Phytopharm repeatedly made clear that hoodia was no longer a priority and that resources would be directed towards their pharma pipeline. The company conducted negotiations, did not come to a suitable agreement with any parties, and subsequently decided that the best way forward for hoodia was to return the rights to CSIR.”

According to CSIR’s Media Relations Manager, Tendani Tsedu, the center recently started an internal review of H. gordonii clinical data and also applied for additional funding in order to hire external experts to assist with the review (e-mail, March 14, 2011). “Detailed review of all data will be subject to the necessary funding being obtained,” said Tsedu. If the review is completed, involved parties will then advise CSIR on its options for developing H. gordonii-based products.5 Johan Hattingh, CSIR’s group manager of intellectual property and technology transfer, said in a press release, “The challenges must not be underestimated and the development of an effective hoodia-based product will need scientific innovation and substantial investment in order for it to be successful.”5

Hattingh’s statement reflects Phytopharm’s challenging history with P57. After gaining patent rights from CSIR, in 2002 Phytopharm partnered with Pfizer (New York, NY), the world’s largest biomedical and pharmaceutic company, to produce a weight-loss H. gordonii drug.4 But a year later, Pfizer stopped these operations, reportedly due to a merger with Pharmacia and the resulting closure of its Natureceuticals group.3

In 2004, Phytopharm teamed up with Unilever (Rotterdam, Netherlands), a global manufacturer of food, home care, and personal care products, to develop an H. gordonii-based functional food product.4 But after investing a reported $40 million in the project, Unilever terminated the agreement in 2008 after its research concluded that P57 failed to meet the company’s high standards for safety and efficacy.

Amidst these 2 canceled partnerships with big-name developers, Phytopharm continued to reaffirm its strong belief in H. gordonii. After the recent patent transfer to CSIR, it is claiming that H. gordonii is an interesting product with promise, and Phytopharm CEO Tim Sharpington stressed to NutraIngredients.com that he thinks solid formulations (as opposed to liquid formulations) would be most successful.2,6

But, as discussed in a 2009 HerbalGram article, some toxicity and efficacy issues might be unavoidable.4 Because P57 is a highly isolated compound, it could likely be more toxic than a part of the whole plant or a pressed H. gordonii juice or powder. Also, the various growing conditions of cultivated H. gordonii—the only form of the plant allowed for export and import—might result in a lower level of triterpenes, which can decrease efficacy. According to Phytopharm, potential issues surrounding cultivated H. gordonii played no role in its transfer decision.

The indigenous San people of southern Africa developed the original knowledge of the plant’s appetite-suppressing potential, using it for generations to help calm the hunger pains of men on long hunting expeditions.4 After obtaining and sharing the patents on P57, CSIR and Phytopharm were accused of biopiracy. CSIR then signed an agreement with the San people that gives them 6% of royalties from the sale of H. gordonii-containing products and gave them 8% of all milestone payments that CSIR received from Phytopharm.

“The initial reaction was disappointment,” said Roger Chennells, the San’s attorney (e-mail, February 28, 2011). “The San thought that [Phytopharm] would take the product to market, and that the benefits (royalties) would begin to flow.”

Chennells said that, based on discussions the San had with CSIR, “it is clear that the scientific data on the hoodia shows a very powerful product, and not one that has lacked potential or potency. It, however, requires a careful strategy to take it forward.”

According to Chennells, the San are hoping that CSIR and its partners receive funding to do the necessary base line analysis research in order to target and place H. gordonii successfully in the market. “This will require further efficacy and safety tests, which might take another 2 or 3 years,” said Chennells, noting that this would bring “a solid flow of benefits” for South Africa and the San. In late December of 2010, Chennells told SciDev.net that the San have received about $73,000 from the agreement with CSIR and are happy with the arrangement.6

Chennells added that the San have a new benefit sharing agreement concerning Sceletium spp. (Aizoaceae), whose mood-enhancing properties are patented and is currently in the final stages of trials. The San recently approached the South Africa government for assistance in extending the benefit-sharing requirements of the Biodiversity Act (under the Conference for Biological Diversity) to H. gordonii, Sceletium, and several other South African plants. This would require companies selling such products to engage with the San and negotiate a fair and workable compensation for the traditional knowledge-based component of the product.

—Lindsay Stafford

References

  1. Bouckley B. Phytopharm hints at solid future for hoodia. NutraIngredients.com. July 22, 2010. Available at: www.nutraingredients.com/Product-Categories/Phytochemicals-plant-extracts/Phytopharm-hints-at-solid-futurefor-hoodia. Accessed February 7, 2011.
  2. Bouckley B. Phytopharm CEO insists hoodia still ‘interesting’ despite patent disposal. NutraIngredients.com. December 8, 2010. Available at: www.nutraingredients.com/Industry/Phytopharm-CEO-insists-Hoodia-stillinteresting-despite-patent-disposal. Accessed February 11, 2011.
  3. Wynberg R. Rhetoric, realism and benefit-sharing use of traditional knowledge of Hoodia species in the development of an appetite suppressant. Journal of World Intellectual Property. 2004;7(6):851-876.
  4. Stafford L. After another canceled partnership, the future of hoodia remains unclear. HerbalGram. 2009;82:22-24. American Botanical Council.
  5. CSIR takes the lead towards further development of Hoodia [press release]. Pretoria, Gauteng, South Africa. Council of Scientific and Industrial Research: November 30, 2010.
  6. Makoni M. San people’s cactus drug dropped by Phytopharm. SciDev.Net. December 20, 2010. Available at: www.scidev.net/en/news/san-people-s-cactusdrug-dropped-by-phytopharm-1.html. Accessed February 14, 2011.