CBD and ABS: from scientific needs
to public perceptions – road models
for the Pharmaceutical Industry

Dr. Thomas Henkel, CEOJBA high level meeting on CBD and ABS,Feb. 8-9, 2007

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InterMed Discovery is dedicated to discover and develop
innovative products for the life science industry based onnatural products (NP)confidential

IMD - The Company

MBO of Bayer HealthCare R&D with a world leading proprietary Natural Products
technology platform

Founded 1.2.06 as privately owned venture with presently 22 staff

transfer of all BHC R&D natural product related assets into IMDNew location at the BioTech center (BMZ) Dortmund in the center of Northrhine
Westfalia, Germany

Customers come from pharmaceutical, agrochemical and food industry

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The strong foundation
Organisms
large proprietary collection of microbial genetic sources rigid pre-selection and life cycle management
 world wide network of suppliersWork up

proprietary technology platformworld wide largest pure NP compound library

Logistics/biol. Testing
standardized and automated process chain
 integrated data base conceptOChemical characterisation:
Dereplication
 high quality structure elucidation with systematic database support

OOOOOOOIMD represents a unique integration of know how and processes combined with proprietary sample
collections with high opportunity for value generation
confidentialCBD and ABS:
from scientific needs to public perceptions – road models
for the Pharmaceutical Industry•

finding new products in the Life Science Industry and the role ofNatural Product research•

Public perceptions•

best practice - some examples•

conclusion

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The life sciences R&D challenge
Capitalize on Innovative Technologies and new leads
Target ID/evaluation

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HTS

DiseaseHypothesis

LeadID

leadPh.I Ph.II Ph.III
optimisation

lead candidate

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launchTarget validation - Ex-vivo humanized models
Biomarker ID
High quality leads
pharmacogenomics
High content screening
Systems biologyÎYou need more than just compounds
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Research and development of new drugs high risks and investments
800 Mio Euro investment, approx. 12 years

development

research
Basic researchPre-clinic
Phase I
Phase II

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optimisation
Candidate selection
5%

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7.5 %Success rates

randomsourcing

directed search

Lead compoundSingle compound
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Screening Workflow
automated synthesis

Sources

repository

NPshighNumberHTS

hit evaluation

shortTime

Lead compound identification

at low probability of successconfidential

NP Research is expensive and risky
Cultivation

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Nature’s unlimited Reservoir„Life Counts, M. Gleich et al.“Amount ofbacteria:
Animals:
known species:
unknown species:

5 x 1030
1 x 1018
1,75 x 106
1 x 108 (estimate)

per one human body exist
trees
birds
animals total

500
50
167.000.000• rich source for innovative chemical compounds• only small part of reservoir investigated up to nowÎtoo much to investigate – where should we start?
Îvalue (scientific and commercal) of TKnowledge is limited
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Multiple sources for identical compound• There are 8 taxus plant species from different parts in theworld (NA, Europe, Asia!) reported to produce paclitaxel and16 congeners• even a fungus appears as a producer!

⇔O
HOTaxus (Eibe)

NHO

AlternariaOHOOOOOOOHOOH

OStrobel et al. (1996)
Dahiya (1998)

H

Who owns this finding regarding ABS?
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Multiple sources for identical compound (2)bacteria

fungi
z micro-organisms producing identical compounds are spread allover the worldz Different “endemic” plants of the same family produce identical
types of compounds
z species are distributed according to habitat properties rather than“country borders”
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sustainability - in our all interest• A real threat of endangered species (tiger, rhino) lies in the increased
usage of traditional medicines but not form use of ethical drugs• Safety and quality issues as well as cost of goods (COG) aspects makesustainable production for drugs obligatory⇔OHOTaxus (Eibe)

NHO

Taxus cell culture

OHOOOOOOOOHOOH

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Example Paclitaxel: Currently different sustainable processes
are in place (cell culture, needle harvest etc.)

Sustainability issues do not limit drug development!
confidentialCBD and ABS:
from scientific needs to public perceptions – road models
for the Pharmaceutical Industry•

finding new products in the Life Science Industry and the role of
Natural Product research•

Public perceptions•best practice - some examples•conclusion

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Public perceptions•The image of the Pharma industry in particular, as well as thelife science industry as a whole is bad•

There is increasing pressure from the developing countries andNGOs to change behavior, business terms and general policies
at an international level (TRIP, WTO, UN-EP)•e.g. bio-prospection is quite often regarded as bio-piracy without
reflection of the details

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Governing Biodiversity - The Realisation of Access and Benefit
Sharing under the Convention on Biological Diversity
August, 25th 2005, Roskilde University, Denmark

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Governing Biodiversity - The Realisation of Access and Benefit
Sharing under the Convention on Biological Diversity
August, 25th 2005, Roskilde University, Denmark

Citations:“Conclusion 1: In the realm of biodiversity governance, voluntary businessmeasures based on corporate responsibility are inappropriate to safeguard
access and benefit sharing.
Conclusion 2: An internationally binding protocol is required to enhance theimplementation of ABS.
Conclusion 3: ABS loses its wind before it even gathered way.”

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Governing Biodiversity - The Realisation of Access and Benefit
Sharing under the Convention on Biological Diversity
August, 25th 2005, Roskilde University, Denmark

Citations:“Perspectives
Companies from the industrialized North are the primary economic beneficiaries
of genetic resources that are the property of the South.
… will ABS deliver for biodiversity?
Between 1991 and 2000, projects channeled about US$ 2.7 million
to conservation purposes in Costa Rica being … rather insignificant comparedwith …eco-tourism which accounts for US$ 650 million per year
Do the international negotiations for an ABS regime simply come too late? … it
indicates an important point of critique of ABS: the mechanism is not capable ofsufficiently tackling the root causes of biodiversity loss.“confidential

Governing Biodiversity - The Realisation of Access and Benefit
Sharing under the Convention on Biological Diversity
August, 25th 2005, Roskilde University, Denmark

The author’s comments:• Most of the Pharma industry did not reflect ABS properly since they lost
general interest in this matter• The benefit of bio-prospecting of the Pharma industry is overestimated – there
is no cost benefit scheme known to the author• The life science industry has, if any, only very limited responsibility for the loss
in diversity through environmental damages

confidentialCBD and ABS:
from scientific needs to public perceptions – road models
for the Pharmaceutical Industry•

finding new products in the Life Science Industry and the role of
Natural Product research•

Public perceptions•

best practice - some examples•

conclusion

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Protection of Traditional Knowledge (TK)•“Shaman Pharmaceuticals” was founded in the US in the ‘90 targeting theincrease of probability of success in drug finding via making use of TK in
conjunction with a fair compensation of the provider•

Shaman developed compensation and reimbursement schemes reflecting atleast some of the issues regarding TK•different projects were reported as a success story; the business idea wasrewarded to be innovative and followed with high interest•

however, “Shaman pharmaceutical” went bankrupt

Î the value of TK as factor for a regular income stream appears to
be overestimatedÎ drug discovery is a difficult business

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Example for best practise:Statements and Procedures for the active integration of the Convention on Biological
Diversity (CBD) proposed by theGerman Association of Research-Based Pharmaceutical Companies(VFA)“General StatementThe German Association of Research-Based Pharmaceutical Companies (VFA) states
1. to support the intentions of the Convention on Biological Diversity
2. to confirm its sincere interest and support in conservation of biological diversity andsustainable use of its components
3. to offer constructive proposals for adequate multi-factorial compensation of each party´scontribution in co-operations between receivers and providers of genetic resources(Receiving Party and Providing Party, respectively)
4. that the interests of all participating parties need to be respected and realised in order tovitalise the CBDThe VFA´s understanding of such collaborations under the CBD is that those need to result in
exploitable outcomes. To enable the Pharmaceutical Industry as a Receiving Party to
optimally fulfil the above general criteria, several elements need to be prepared. …”
confidentialCBD and ABS:
from scientific needs to public perceptions – road models
for the Pharmaceutical Industry•

finding new products in the Life Science Industry and the role ofNatural Product research•

Public perceptions•

best practice - some examples•

conclusion

confidential

enabling the utilisation of natural products through ABS
bacteria

plantsinsectsfungi
Marine organisms⇒ ABS generally will not result in significant revenue streams for provider
countries and will not be able to protect bio-diversity⇒ However, locally ABS can induce immediate and significant impact andprogress in R&D⇒ Interest of the parties should be allowed to be balanced bilateral – the “UNWatchtower” will highly likely not work on its own⇒ compensation has mutually to be agreed in adequate balance to the realvalue generation - adequate sharing of risks and benefits has to be insured
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Thank you!

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