Hoodia, a case study

1963-2008

November 2008

Dr Vinesh Maharaj

Research Group Leader

CSIR, Biosciences

Slide 2 © CSIR 2008 www.csir.co.za

CSIR Campus, Pretoria

Biosciences (220 people)

Slide 3 © CSIR 2006 www.csir.co.za

Hoodia:

History of use

•Hoodia research was stimulated by traditional use of

plant by San people

•Used by San people as substitute for food and water

(Marloth, 1932: White and Sloan, 1937)

•Has an insipid taste and used to quench thirst (Pappe,

1862)

Hoodia in its natural habitatHoodia in flower

Slide 4 © CSIR 2006 www.csir.co.za

Hoodia:Early Research

1963-1971

• NFRI of CSIR launched a project to investigate food from

the “veld”

• Nutritional value and long term toxicity studies was the

focus of study

• Hoodia was one of several 100 plants

• Prepared several extracts of the plant

• Extracts tested in rodents

• Appetite suppressant properties with weight loss

• No apparent side effects

• Data kept confidential

Slide 5 © CSIR 2008 www.csir.co.za

Hoodia:

Early Research1983-1986

•Active isolated through bioassay guided fractionation

•Fractions tested in vivo

•Innovation made possible by acquisition of world-class

instrumentation for structure elucidation

Slide 6 © CSIR 2006 www.csir.co.za

Hoodia Development Cycle

DiscoveryDevelopment: Clinical

and regulatory approval

Commercial

Sales

Time

Cum

ula

tive Investm

ent

CSIR

LeadHit Preclinical

Slide 7 © CSIR 2006 www.csir.co.za

Hoodia Development Cycle

DiscoveryDevelopment: Clinical

and regulatory approval

Commercial

Sales

Time

Cum

ula

tive Investm

ent

CSIR

LeadHit Preclinical

CSIR/Phytopharm

Slide 8 © CSIR 2006 www.csir.co.za

Hoodia Development Cycle

DiscoveryDevelopment: Clinical

and regulatory approval

Commercial

Sales

Time

Cum

ula

tive Investm

ent

CSIR

LeadHit Preclinical

CSIR/Phytopharm

Multinational

Slide 9 © CSIR 2006 www.csir.co.za

Hoodia: Manufacturing in SA, technology transfer

• Botanical and Clinical Supplies Unit for

the manufacture herbal extracts

• Manufacture extracts in compliance with

GMP

• Material approved for clinical trials

• Quality control

0

100

%

28.38

2.55

1.85

3.45

24.034.42

22.7418.505.5414.10

27.63

25.19

31.94

30.77

28.93

37.0233.87

32.37

34.45

35.19

38.12

40.3538.53

Time (min.)

Re

lative

in

ten

sity

0

100

%

28.38

2.55

1.85

3.45

24.034.42

22.7418.505.5414.10

27.63

25.19

31.94

30.77

28.93

37.0233.87

32.37

34.45

35.19

38.12

40.3538.53

Time (min.)

Re

lative

in

ten

sity

Slide 10 © CSIR 2006 www.csir.co.za

Hoodia cultivation-Supply Chain, technology transfer

Slide 11 © CSIR 2006 www.csir.co.za

“..San people are custodians of an

ancient body of traditional knowledge

…related inter alia to human uses of the

Hoodia plant …”,

“The CSIR acknowledges the existence

and the importance of the traditional

knowledge of the San people, and the

fact that such body of knowledge,

existing for millennia, predated scientific

knowledge developed…”

Indigenous Knowledge & the CSIR/San

Agreement

S A San Council visits CSIR facilities

Slide 12 © CSIR 2006 www.csir.co.za

CSIR/San Agreement: Numbers

CSIR and San agreed for CSIR to pay eight percent of all

milestone payments it receives from its licensee, UK-based

Phytopharm plc, as well as six percent of all royalties that

the CSIR receives once the drug is commercially available.

Potential income into a San Hoodia Benefit Sharing Trust

Trustees include:

•SA Department of Science and Technology

•CSIR

•San Representatives (≠ Khomani,!Xun, Khwe)

•Other San in the southern African region

•Working Group of Indigenous Minorities in Southern

Africa

Slide 13 © CSIR 2006 www.csir.co.za

• Full involvement of South African scientists in

development programme (capacity building)

• Transfer of state-of-the-art phyto-medicine production

technology to South Africa

• Potential royalty revenue through licensing of patented

technology; milestone payments linked to clinical trials

• Global recognition of SA’s innovation capacity

• Agroprocessing businesses established in SA for both

commercial and community farmers

Hoodia Licensing: Benefits to SA

Slide 14 © CSIR 2006 www.csir.co.za

Challenges in Benefit-sharing

• Man-made borders vs cultural & biodiversity across borders

• How to contract when revenue/benefits to parties are uncertain and linked to outcome of clinical trials

• Balancing trade secret/knowledge protection with transparency

• Extremely difficult to operate in policy vacuum

• At what stage of product development cycle must benefit-sharing agreement be signed with owners of Indigenous Knowledge?

• Very long time from project idea to commercial success

Three pillars of Bioprospecting: Hoodia demonstrates the

value of bringing all three together

Biodiversity

Scientific innovation Indigenous Knowledge