HerbalEGram: Volume 8, Number 3, March 2011
Phytopharm Returns Hoodia Gordonii Rights to South African R&D Company
Just 4 months after maintaining 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).
Phytopharm had been leasing an exclusive H. gordonii patent from CSIR, one of
Africa’s leading research and development institutions, since 1998.3 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 1995.2-4
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 in 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 been 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 a CSIR press release, the center will first conduct a detailed scientific review of the entire H. gordonii program’s intellectual property and clinical studies.
Involved parties will then advise CSIR of what its options are for developing H. gordonii-based products. Three months
after the Phytopharm transfer, however, CSIR has not initiated any activity on
these tasks, said CSIR’s Media Relations Manager, Tendani Tsedu (e-mail, February 8, 2011). Johan Hattingh, CSIR’s group manager of intellectual property and
technology transfer, said in the 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 problematic history with P57. After gaining patent rights from CSIR, in 2002 Phytopharm partnered with Pfizer (New York, NY), the
world’s largest biomedical and pharmaceutical 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 two canceled partnerships with big name
developers, Phytopharm continued to reaffirm its strong belief in H. gordonii. Even after the recent patent transfer to CSIR, it
is claiming that H. gordonii is an
“interesting” product with promise.”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 decision to transfer P57 rights back to CSIR.
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 the Hoodia 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” to 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., whose
mood enhancing properties are patented and is currently in the final stages of
trials. The San recently approached the South African government for
assistance in extending the benefit sharing requirements of the Biodiversity
Act (under the Conference for Biological Diversity) to H. gordonii and 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
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.
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.
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