from research to revenue iv: capturing business opportunities in asia

216
From Research to Revenue IV: Capturing Business Opportunities in Asia

Upload: ghbn

Post on 15-Jan-2015

2.747 views

Category:

Business


6 download

DESCRIPTION

A full collection of the presentations made Wednesday, December 3, 2008 at Mississauga Living Arts Centre for From Research to Revenue IV: Capturing Business Opportunities in Asia.

TRANSCRIPT

Page 1: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 2: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 3: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 4: From Research to Revenue IV: Capturing Business Opportunities in Asia

THANKS TO OUR SUPPORTERS

Page 5: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 6: From Research to Revenue IV: Capturing Business Opportunities in Asia

Outsourcing in AsiaOutsourcing in AsiaMadhav Murti, PricewaterhouseCoopers LLPMadhav Murti, PricewaterhouseCoopers LLP

Page 7: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

The changing dynamics of pharma outsourcing in Asia:

Are you readjusting your sights?

Page 8: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Introduction

PwCGlobal Sourcing Advisory

Page 9: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Agenda

1. Introduction

2. Strategic context of outsourcing and location decisions in Asia

3. Moving up the value chain: the changing nature of pharma outsourcing in Asia

4. Evaluating the landscape: the location context for outsourcing decisions

5. Looking ahead

Page 10: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Strategic context of outsourcing and location decisions in Asia

Page 11: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Cluster One – Pharma Revenue Constraints

Patent expiry• In 2006 > 90% of Big Pharma’s total revenues were from medicines that

had been on the market > 5 years. Expiry of patents related to many of these products could result in significant erosion of revenues (estimated around $157 billion)

Need for R&D productivity• The industry has invested twice as much in R&D in 2006 as it was a

decade earlier but only producing two – fifths of the medicines it then produced

Pricing Pressures in healthcare markets

Quest for improved margins and growth

1

Page 12: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Cluster Two – Asia growth focus

Growth in Asian pharma markets• China and India pharma markets are experiencing annual growth of 10 -

15% and are expected to grow to about 150% and 90% respectively of US market

Growth in Asian pharma manufacturing capability• Asian Contract Manufacturing Organizations (CMO) are expected to

account for about 15% of the total CMO market by 2010.

• Rapid maturity with increase in FDA approvals and GMP certification

• Attractive cost arbitrage on manufacturing operations

Growth in Asian Scientific Resource Base and Capabilities

Growth in Patient Pool• Asia accounts for > 60% of the world’s population

• Vast clinical trial pool offers significant cost savings as well as reduction in patient enrolment time

2

Page 13: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Cluster Three – East/West convergence/divergence trends

Intellectual Property & Legal Landscape• Though much needs to be done, IP protection and rights are increasingly

improving in certain Asian countries

Clinical Trials and pharma regulation• Regulatory delays and complexities can hinder the development of clinical

trials

East/West disease profiles• On the one hand, variations in disease profiles due to differences in ethnic

origin, diet and environmental factors, yet• On the other, reduction in divergence due to urbanization and

convergence of tastes and lifestyles between the East & West

Escalation in Labour and other overhead costs

3

Page 14: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Cluster Four – Technological/business model forces

Need for more advanced/flexible manufacturing• Development and evolution of new products will drive demands for newer

technology and a more sophisticated manufacturing environment

Closing the gap between R&D, manufacturing and patients• Need and desire to close the gaps within the pharma value chain will

impact the decisions on location and sourcing model options

Blurring of assessment of Core vs Non Core activities• Opportunity to tap into external skills to accelerate own capabilities will

expand the scale and scope of what can be outsourced• Third party models evolve rapidly to more collaborative ‘partnership’ focus

Networked Business Models• Pharma business model moving away from fully integrated operations to a

networks of collaboration and discovery (Eli Lilly – FIPCO to FIPNET)

4

Page 15: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Moving up the value chain: the changing nature of pharma outsourcing in Asia

The trend towards high end innovation:

• from late stage clinical trials and low cost manufacturing

• moving up the value chain: facilitated by the evolution in IP protection

•Risk based deals :Eli Lilly with Nicolas Piramal, Suven Pharma, Hutchinson MediPharma

• “in-sourcing” (Eli Lilly, GSK, Astra Zeneca)

• researched-based partnerships between pharma companies (Merck- Advinus Therapeutics, Ranbaxy, Dr.Reddy’s)

Page 16: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Moving up the value chain

Rapid expansion of clinical trials in Asia

•India 2003: 40 – 50 clinical trials

2007: 270 clinical trials

2008: completed 737 clinical trials

•China 2008: completed 870 clinical trials

Drivers:

- cost

- IPP improvement

- “treatment naïve” patients

- recruit more quickly from a smaller number of sites

Page 17: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Moving up the value chain

Manufacturing scales up

• cost: India 50% cheaper than west

• large pool of qualified talent to run manufacturing plants

- India:

> 100 FDA approved facilities

- China:

> source of APIs shipped globally

> first FDA approved site for finished drug

> increased effort of SFDA

Page 18: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Moving up the value chain

Manufacturing scales up

David Brennan, CEO AstraZeneca:

“all active pharmaceutical ingredients will be produced externally within a decade as part of the strategy of maximizing the efficiency of our supply chain while maintaining the highest possible standards of quality and security of supply.”*

AstraZeneca plans to increase its outsourcing drastically from China and India. The firm has set up a dedicated sourcing centre in Shanghai.

*Financial Times, 16 April 2008

Page 19: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Evaluating the landscape: the location context for outsourcing decisions

Page 20: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Evaluating the landscape: the location context for outsourcing decisions

Outsourcing index – ranking of Asian territories across all factors

Page 21: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Evaluating the landscape: the location context for outsourcing decisions

Cost ranking of Asian territories

Page 22: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Evaluating the landscape: the location context for outsourcing decisions

Risk ranking of Asian territories

Page 23: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Evaluating the landscape: the location context for outsourcing decisions

Market Opportunity ranking of Asian territories

Page 24: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Looking ahead

• China & India spearhead growth in Asian pharma

• Singapore will maintain position as centre for research and innovation

• China, India and Singapore remain hotspots with Korea and Taiwan becoming increasingly significant

• Outsourcing will continue to move up the value chain

• As pharma investments in Asia grow: high end drug discovery in Asia plays a more important role

• Insourcing preferred model for higher end activities, complemented by strategic partnerships

• No “one size fits all” => mixed approach

Page 25: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Looking ahead

“For us, China is not about outsourcing and cheap labour…It’s about different science…Within 5 to 10 years we will be moving from 'made in China’ to ‘discovered in China’”

Moncef Slaoui

Chairman of Research and Development, GlaxoSmithKline

Page 26: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Sourcing Decisions in times of uncertainty and turmoil

Even in the best of times outsourcing solutions require careful planning and structuring to deliver full value. The temptation now is to move quickly to extract additional value.

But, in the face of growing economic uncertainty and increasing market complexity, programmes demand a higher level of scrutiny and focus

Page 27: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Buy Side Organizations look to downscale/ cancel

current outsourcing commitments

Buy Side Organizations look to rapidly reduce

scale/cost of insourced commitments

Market volatility continues (Currency

fluctuations, Stock Price movements)

Economic slowdown inhibits organizational

ability to sustain growth & improvement

initiatives

Issue• Service Providers faced with weak

financial leverage due to excess capacity and high fixed cost levels

• Service Provider business model/ operational plans/ability at risk

• Captive Operations become attractive options for acquisitions

• Business Case strengthens for variabilizing fixed costs

• Currency hedging becomes a prominent part of deal structuring and economics

• Emergence of new attractive supply side locations due to weakening of local currencies and increased availability of resources

• Higher risk profile of Alternate Sourcing arrangements

Potential Impact Opportunities/ChallengesBuy Side• Negotiation/Renegotiation of

additional benefits ( incremental cost impact, leverage capacity etc.)

• Need for additional rigor in service provider evaluation/selection

• Potential to accelerate time to benefit• Higher level of risk assessment on

service provider business viability

Sell Side• Retention of resource bench in face of

uncertain demand• Negotiation/Renegotiation of deals to

offset capacity and leverage issues• Expansion of footprint into emerging

supply side locations• Consolidation of Service Providers

Fig 1 – PwC Analysis

Source: Sourcing decisions during economic downturns, PwC Point of View Dec 2008

Key areas for consideration

Page 28: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Current market conditions expose new opportunities to reap significant financial and non financial benefits from alternate sourcing arrangements even in the face of market turmoil.

Organizations would be well served to explore these opportunities in their strategic context and develop appropriate sourcing strategies that consider both short and long-term implications.

Increased market complexity and risk are clear concerns requiring careful consideration and sharp focus, but they should not stop organizations from taking action that could build business flexibility and accelerate competitive advantage on the up-side of an economic recovery.

CONCLUSION

Source: Sourcing decisions during economic downturns, PwC Point of View Dec 2008

Page 29: From Research to Revenue IV: Capturing Business Opportunities in Asia

PricewaterhouseCoopers LLP Changing dynamics of Pharma Outsourcing in Asia

Thank you

The changing dynamics of pharma outsourcing in Asia:

Are you readjusting your sights?

Madhav Murti

Vice President - Global Sourcing Advisory

[email protected]

Page 30: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 31: From Research to Revenue IV: Capturing Business Opportunities in Asia

Analysis of Asian MarketsAnalysis of Asian MarketsModerator: Gail Garland, Axela Inc.Sarah Frew, McLaughlin - Rotman Centre for Global HealthPaul Stinson, CAPRA InternationalRon Choudhury, Aird & Berlis LLPHadi Salah, Frost & Sullivan

Moderator: Gail Garland, Axela Inc.Sarah Frew, McLaughlin - Rotman Centre for Global HealthPaul Stinson, CAPRA InternationalRon Choudhury, Aird & Berlis LLPHadi Salah, Frost & Sullivan

Page 32: From Research to Revenue IV: Capturing Business Opportunities in Asia

Analysis of Asian Markets:Focus on India and China

December 3, 2008Hadi Salah

[email protected]

Page 33: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

APAC? Why should I care?

Customer Base: • 54% of the world’s population• Unprecedented population growth• Growing aging population

Revenue Potential:• 33% of the world’s GDP• Increasing affluence• Estimated $889.1 billion total healthcare market (2008)

Page 34: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

Key Healthcare Market Segments

Healthcare

Pharmaceuticals

Biotechnology

Medical devices

Diagnostics

Healthcare ITPatient care

Clinical research

Contract research/outsourcing

Page 35: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

India: Economic Trends

• One of the fastest growing economies in the world

• Third largest economy in Asia, after Japan and China

• Growing at 7-10% per year (2004-2007), GDP expected to reach $1.45 billion by 2010 (CAGR of 13.1% from 2000-2010)

• Per capita income increasing (currently at $5)

• Inflation is stable at 3.8-4.6%

Page 36: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

India: Pharmaceuticals Market Segment

0

2

4

6

8

10

12

14

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Mark

et

Siz

e (

$ B

illio

n)

Page 37: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

India: Biotechnology Market Segment

0

1

2

3

4

5

6

7

8

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Mark

et

Siz

e (

$ B

illio

n)

Page 38: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

Investment in India: Drivers and RestraintsR

estr

ain

tsD

rive

rs

High

Med

Low

Low

Med

High

Low cost of

production

* Length of arrow indicates relative impact

Low cost man

power, strong

scientific base

and talent

Low healthcare

per capita

spending

Highly

fragmented

market

Government

incentives

Entry of large

global pharma

firms

Rural penetration

potential

Emerging APAC

healthcare hubs

Page 39: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

China: Economic Trends

• Fourth largest economy in the world, after the US, Japan, and Germany

• Annual growth rate estimated at 8% (2006-2010)

• Healthcare industry is seventh largest in the world

• High per capita healthcare spending relative to India ($20 vs $5), low relative to developed nations ($700 for US)

Page 40: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

China: Pharmaceuticals Market Segment

0

10

20

30

40

50

60

70

80

90

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Mark

et

Siz

e (

$ B

illio

n)

Page 41: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

China: Biotechnology Market Segment

012

34567

89

10

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Mark

et

Siz

e (

$ B

illio

n)

Page 42: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

Investment in China: Drivers and RestraintsR

estr

ain

tsD

rive

rs

High

Med

Low

Low

Med

High

Rapid economic

growth,

increased

purchasing

power

* Length of arrow indicates relative impact

Increasing private

investment is

driving innovation

Lack of clarity

and policies

Inadequate legal

enforcement

Government

incentives and

increased

investment

Insufficient IP

protection

Rural penetration

potential

Weaker

management

training

Page 43: From Research to Revenue IV: Capturing Business Opportunities in Asia

December 3rd, 2008© Frost & Sullivan

Thank you

Hadi SalahIndustry Analyst

Technical InsightsFrost & Sullivan

“We accelerate growth”

Page 44: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

The Indian and Chinese Health The Indian and Chinese Health Biotech Industries:Biotech Industries:

Competitors or Collaborators of Competitors or Collaborators of Canadian Firms?Canadian Firms?

December 3, 2008 December 3, 2008

Sarah E. Frew, [email protected]

McLaughlin-Rotman Centre for Global HealthProgram on Ethics and Commercialization

Page 45: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

McLaughlin-Rotman Centre For Global Health

• Based in MaRS

• 50 people

• International talent

• Over $50 Million raised for research

• Spin off company: FIO Corporation

Page 46: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Purpose: To explore how the domestic

private sector in Developing Countries (DCs) can contribute to the development of health technologies that address local health needs.

Cases include: India, China, Brazil, South Africa, Ghana, Tanzania, Rwanda

Qualitative Research Methods:

• Semi-structured interviews with key informants

• Background documents

Private Sector Development in Developing Countries: Innovative Firms

Page 47: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Purpose: To explore how the domestic

private sector in Developing Countries (DCs) can contribute to the development of health technologies that address local health needs.

Cases include: India, China, Brazil, South Africa, Ghana, Tanzania, Rwanda

Qualitative Research Methods:

• Semi-structured interviews with key informants

• Background documents

Private Sector Development in Developing Countries: Innovative Firms

Objectives:1. Survey core competencies

2. Explore how, when and why IDC SMEs form linkages

3. Assess capabilities in: human and financial R&D resources, manufacturing, intellectual property and regulatory affairs

4. Identify incentives for and barriers to addressing local health needs

5. Explore financial issues

Page 48: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Private Sector Development in Developing Countries

Nat. Biotechnol. 25 (4), 403-417 (2007). Nat. Biotechnol. 26 (1), 37-53 (2008).

Brazil: Nature Biotechnology 26 (6), 627-644 (2008).

Page 49: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

India in Brief

• Population: 1.1 Billion (1.6B/2050)

• Leading causes of death– Heart Disease– Cerebraovascular Disease– Infectious and parasitic Diseases

(Diarrhoeal, TB, HIV/AIDS)– Lower respiratory Diseases

• Biosciences and Engineering– 700,000 Post-graduates– 15,000 PhDs – 15,000 scientists in Nat’l Res Labs– 17,000 Medical Practitioners / yr.

• Total Biotech Market: US$2.2B (growing at 37%)

– Targets: $5B by 2010 – 10% global market by 2010

• Total No. of biotech cos: >280– >75% less than 10yrs old.– Growing 35-40% per year

• BioPharmaceutical market: US$1.04B

– Vaccines, therapeutics, diagnostics– 53% Export– 47% Domestic ~= $500M– Domestic vaccine growing 38%

• Increasing Share of Global Contract Service Industry by 45 CROs

– 2005: $100-120 million, growing 20-25% / yr.

– Projected to reach $2 billion by 2010 by Frost & Sullivan.

– 35% of their business in drug discovery (synthetic chemistry)

– 65% in clinical trials arena

Page 50: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

New DelhiPanacea BiotecLifecare Innovations

Mumbai / PuneWockhardtSerum Institute of IndiaBharat Serums and VaccinesReliance Life SciencesSIRO ClinpharmNicholas Piramal

HyderabadShantha BiotechnicsBharat Biotech InternationalIndian ImmunologicalsDr. Reddy’s LaboratoriesTransgene BiotechBiological E

BangaloreBioconSyngeneClinigene InternationalBhat Bio-Tech IndiaStrand GenomicsAvestha GengraineGangagen

Case Studies of 21 Indian FirmsIncluding 10 of Top 20 Indian Biotech Firms

Page 51: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Biocon Limited, BangaloreFinancing North American SMEs• Proprietary Fermentation Technologies

– PlaFractor Technology (2001 US Patent)– Cost-effective process for statins, etc.

• Affordable products for domestic market– Insugen™ (human recombinant insulin) for

India’s 30 Million diabetics (6% adults) priced ~50% lower than imported product

• Expanding development capabilities and marketed products through subsidiaries and strategic alliances

– Syngene (w/ BMS, e.g.), Clinigene– Biocon Biopharmaceuticals: JV w/CIMAB,

Cuba for EGFR mAb in India– Abraxis BioScience: GCSF and Abraxane– JV w/ NeoPharma for Gulf countries

• Co-development partnerships – Vaccinex, therapeutic antibodies– Nobex (acquired in ‘05), filed PCT patent for

oral insulin manufacturing process 2006

“We’ve actually not only helped (Nobex) to stay alive, but we’ve retained their jobs for their employees, we are funding their whole survival. … And here there is an Indian company helping to keep jobs in the US.” --Kiran Mazumdar-Shaw, CEO

Page 52: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

China in Brief

• Population: 1.3 Billion (1.5B/2050)

• Leading causes of death– Malignant neoplasms– Cerebraovascular Disease– Heart disease– Respiratory Disease

• Human Resources & Infrastructure– 400 Biotechnology-related colleges

and research institutes– 30,000 annual life sciences grads– 64 specialized biotech parks– Recruit international scientists– Recruit R&D and biopharma centres

• Government support for Biotech– Investment of $1.7B 2001-2005

• Biotech market generated total revenue of $5.6 Billion in 2007

– 25% Annual Growth– 92% market in Medical/healthcare– Represents 15% of Asia-Pacific

market– Represents < 7% of global market

• Total No. of bio-pharmaceutical cos:

– ~ 250 - 350 companies– 40% growth in last 5 years

• Approved BioPharmaceuticals– 15 products approved– 60 biologics in pipeline, including

~20 antibodies and ~10 vaccines

Page 53: From Research to Revenue IV: Capturing Business Opportunities in Asia

University Health Network and University of Toronto

Presentation Title / Date

Case Studies of 22 Chinese Health Biotechnology Firms

ChangchunGeneScience

BeijingBeijing Wantai Biol.Bio-Bridge Science

CapitalBioChina PKU Bioway

Fusogen PharmaSinocells Biotech.

SinoGenoMaxSinovac Biotech

Starvax Internat’l.

ShenzhenBeike Biotech

Shenzhen Chipscreen BiosciencesShenzhen SiBiono GeneTech

ShanghaiHD BiosciencesFudan-Yueda Bio-techShanghai GenomicsGenon Bio-engineeringHuaguan BiochipSunway BiotechUnited Cell BiotechWuXi PharmaTech

XiamenAmoytop

Page 54: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

WuXi PharmaTech, ShanghaiAiming to be a fully integrated service provider

• Contract Service Company– Founded in 2001 by 4 “returnees”– IPO on NYSE in Aug 2007

• Capabilities include: lead generation and optimization, process research, GMP pilot manufacturing, bioanalytical services

• Aiming to move into: biology and bioanalytical services, preclinical toxicology, animal studies, formulations

• In 2008, Acquired AppTec Laboratory Services (US) for $151 Million

• Clients include: 19/20 top global pharmaceutical companies & 8/10 top global biopharmaceutical companies.

• Compete on cost, operations, and IP protection

Dr. Ge Li, Chairman and CEO, a returning “Sea Turtle”, says: “IP is the lifeblood for a company like ours.”

Page 55: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

• Lack of Advanced Training Programs

• Dearth of Risk Capital and Investment Exits

• Culture for Public-Private Collaboration

• Regulatory Bureaucracy

• Few Incentives to Address Needs of the Poor

Barriers to India and China’s Health Biotech Development

• International Credibility

• Cultural Differences, Language, Travel

• IP Protection Enforcement

• Innovative Culture vs Me-Too Culture

• Lack of Knowledge about International Markets & Regulations

Page 56: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Lessons Learned from India and China’s Health Biotech Sectors

• Focus on locally-relevant products with large domestic markets

• Generate revenues early w/ niche products, & leverage for later growth.

• Explore funding opportunities on a project-specific basis from domestic & international sources (India) and from initiatives at Municipal, Provincial, & State levels (China)

• Be proactive in establishing collaborations with domestic and international public and private organizations

• Protect intellectual property with an eye on global competitiveness

• Take advantage of “Brain Gain” - senior managers trained/worked abroad are instrumental in forging initial partnering relationships

Page 57: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Presentation Title / Date57

Canada Lacks Global Competitiveness

Page 58: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Presentation Title / Date58

A Problem With Canada’s Innovation Agenda

Canada’s Public R&D

investment: > $13 billion

Canada’s commercialization output: ?

Page 59: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Presentation Title / Date59

What Impedes Canadian Commercialization?

Almost exclusive focus on technology push, rather than market demand.

Where market demand is considered, the exclusive markets of focus are industrialized markets such as the United States, Europe and Japan, with little attention paid to the ”Rest of World” markets.

Page 60: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Presentation Title / Date

Enabling Canadian Firms to Reach International Markets

60

Page 61: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

International Biotech Partnering Conference

Results:• Over 200 participants and 70 presenters from companies in India, China, Brazil, South Africa, Ghana, Nigeria, US and Canada. •Arranged over 50 private one-on-one partnering meetings. •We are tracking a number of deals, including 4 with Canadian firms, that are currently under negotiation.

Page 62: From Research to Revenue IV: Capturing Business Opportunities in Asia

Presentation Title / Date

University Health Network and University of Toronto

Presentation Title / Date

Thank You!

Additional funding partners for the McLaughlin-Rotman Centre for Global Health can be found at www.mrcglobal.org

Page 63: From Research to Revenue IV: Capturing Business Opportunities in Asia

China Biopharma – Open China Biopharma – Open for Business!for Business!

Paul StinsonPaul Stinson

CAPRA InternationalCAPRA International

December 3, 2008December 3, 2008

63

Page 64: From Research to Revenue IV: Capturing Business Opportunities in Asia

Here’s What I Will Cover TodayHere’s What I Will Cover Today

Why China is ImportantWhy China is Important What’s Your China Strategy?What’s Your China Strategy? Some Lessons from the TrenchesSome Lessons from the Trenches

64

Page 65: From Research to Revenue IV: Capturing Business Opportunities in Asia

Ignore China at Your PerilIgnore China at Your Peril

Venture Money Available for Knowledge Venture Money Available for Knowledge EconomyEconomy

Science & Tech Parks and Incentives in Every Science & Tech Parks and Incentives in Every Province Province

Five Year Plan 2006-2010 Goals Will Be Five Year Plan 2006-2010 Goals Will Be Achieved!Achieved!

Every Major Pharma Company is ThereEvery Major Pharma Company is There

65

Page 66: From Research to Revenue IV: Capturing Business Opportunities in Asia

Why is Canada so Far Behind in Why is Canada so Far Behind in China?China?

Government to Government Relations since 2005Government to Government Relations since 2005 Canada’s Reliance on US TradeCanada’s Reliance on US Trade CCBC Caters to Large Canadian EnterprisesCCBC Caters to Large Canadian Enterprises

SME’s Generally Not There in Life SciencesSME’s Generally Not There in Life Sciences We are Risk-Averse. We Fear the Unknown.We are Risk-Averse. We Fear the Unknown. Result: Result: Canada’s Engagement is Miles Behind Canada’s Engagement is Miles Behind

AustraliaAustralia

66

Page 67: From Research to Revenue IV: Capturing Business Opportunities in Asia

What’s YOUR China Strategy?What’s YOUR China Strategy?

CME survey – 80% recognize need for China CME survey – 80% recognize need for China Strategy but only 30% have oneStrategy but only 30% have one

Be Entrepreneurial! Plan, then Be Entrepreneurial! Plan, then Implement Implement … … before someone beats you to it!before someone beats you to it!

Follow-up is CriticalFollow-up is Critical Canadian Companies Can Help YouCanadian Companies Can Help You

CAPRA, Sinam, Engage China, Bell AlliancesCAPRA, Sinam, Engage China, Bell Alliances

67

Page 68: From Research to Revenue IV: Capturing Business Opportunities in Asia

CAPRA Will Help You Source CAPRA Will Help You Source Funding & PartnershipsFunding & Partnerships

StrategicAlliance with ChinaBio LLC, ShanghaiStrategicAlliance with ChinaBio LLC, Shanghai Investors Forums – Beijing Dec 11-12Investors Forums – Beijing Dec 11-12 ChinaBio Partnering Forum – Shanghai Jun3-4ChinaBio Partnering Forum – Shanghai Jun3-4 ““Helping China Biotech Become Global Biotech”Helping China Biotech Become Global Biotech” www.chinabiollc.comwww.chinabiollc.com The Balloch Group will finance in China – see The Balloch Group will finance in China – see

www.ballochgroup.comwww.ballochgroup.com

68

Page 69: From Research to Revenue IV: Capturing Business Opportunities in Asia

Some Lessons from the TrenchesSome Lessons from the Trenches

Do not go in alone – China is not for the faint Do not go in alone – China is not for the faint of heartof heart

Use our Embassies & Trade CommissionersUse our Embassies & Trade Commissioners China’s Embassy in Ottawa is there to helpChina’s Embassy in Ottawa is there to help

Science & Tech CounsellorScience & Tech Counsellor Do your Research in Advance – and then be Do your Research in Advance – and then be

Ready for Surprises!Ready for Surprises!

69

Page 70: From Research to Revenue IV: Capturing Business Opportunities in Asia

Recognise Cultural DifferencesRecognise Cultural Differences

Guangxi - RelationshipsGuangxi - Relationships Importance of FaceImportance of Face No Overnight SuccessNo Overnight Success Connections Take TimeConnections Take Time Listen More than Your SpeakListen More than Your Speak Be OpportunisticBe Opportunistic

70

Page 71: From Research to Revenue IV: Capturing Business Opportunities in Asia

Canadians and Chinese Do Business Canadians and Chinese Do Business DifferentlyDifferently

Recognise difference in time-linesRecognise difference in time-lines Canada: Paralysis by AnalysisCanada: Paralysis by Analysis China: Relationships, then ActionChina: Relationships, then Action

Contracts – word vs. writtenContracts – word vs. written Intellectual Property – perception meets realityIntellectual Property – perception meets reality

Page 72: From Research to Revenue IV: Capturing Business Opportunities in Asia

China is Open for China is Open for Biopharma Business!Biopharma Business!

www.caprainc.comwww.caprainc.com

[email protected]@caprainc.com

Page 73: From Research to Revenue IV: Capturing Business Opportunities in Asia

ANALYSIS OF ASIAN ANALYSIS OF ASIAN MARKETS – THE LEGAL MARKETS – THE LEGAL

PERSPECTIVEPERSPECTIVE

Ron ChoudhuryAird & Berlis LLP

[email protected]

Page 74: From Research to Revenue IV: Capturing Business Opportunities in Asia

OverviewOverview

• Asian Legal Systems – Focus on India

• Investment Vehicles

• Intellectual Property Regulation

• Intellectual Property Protection

• Dispute Resolution

• Best practices

Page 75: From Research to Revenue IV: Capturing Business Opportunities in Asia

Legal Systems in AsiaLegal Systems in Asia

• Common law in South Asia• Based on British traditions of common law• India main proponent

• Sharia • Practised in Islamic nations• Code of living• Sharia finance

• Civil law• Japan• Many South east Asian countries

• China• One of the oldest legal traditions in the world• Impact of communism• Rule of law versus rule by law

Page 76: From Research to Revenue IV: Capturing Business Opportunities in Asia

Investment VehiclesInvestment Vehicles

• Tax holidays relevant in determining investment structure

• Joint venture• Generic term encompassing different kinds of partnership

arrangements

• Aims to bring together 2 or more parties with common goal but different organizational strengths to commence or continue venture

• Significant in India due to regulatory restrictions, social or geographic needs

• Wholly-owned vehicles• Subsidiary

• Project office

• Branch

Page 77: From Research to Revenue IV: Capturing Business Opportunities in Asia

IP Regulation in IndiaIP Regulation in India

• India member of WTO and signatory to TRIPS agreement

• Copyright, patent and trademark protection

• Copyright Act reflects Berne Convention on Copyrights

• Indian Patents Act compliant with TRIPS

• Trademarks registered under Trademark Act• Licenses have been granted to drugs with similar

trademarks

• No specific trade secrecy laws

Page 78: From Research to Revenue IV: Capturing Business Opportunities in Asia

IP Protection in IndiaIP Protection in India

• Pharmaceutical patents• Both product and process patent• Pharma companies need to obtain licenses from original

drug manufacturers• May change R&D focus• Compulsory licensing if the patent does not meet the

reasonable requirements of the public at a reasonable price

• Data protection clauses to comply with TRIPS on protection of undisclosed information• Useful for protecting undisclosed test data submitted to

regulatory bodies• Data exclusivity is important element of IP protection

Page 79: From Research to Revenue IV: Capturing Business Opportunities in Asia

Dispute ResolutionDispute Resolution

• Robust judicial system

• Delays due to backlog

• Various trade agreements with US, UK, Japan, China to protect investments

• Agreement provide protection against acts like expropriation and provide dispute resolution procedures between investors and host state

• Arbitration and Conciliation Act based on Model Law on International Commercial Arbitration

• No specific bilateral arbitration treaty or agreement

Page 80: From Research to Revenue IV: Capturing Business Opportunities in Asia

Best PracticesBest Practices

• Calculated risks

• Understand nature of IP rights and protection available

• Ensure adequate registration of IP

• Strong IP violation and dispute resolution clauses in contracts

• IP audit

• Employment contracts

Page 81: From Research to Revenue IV: Capturing Business Opportunities in Asia

QuestionsQuestions

Page 82: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 83: From Research to Revenue IV: Capturing Business Opportunities in Asia

International Commercial Collaborations: Moves for Success

International Commercial Collaborations: Moves for SuccessModerator: David Shindler, BioDiscovery TorontoStuart Wilson, ISTPCanadaAdi Treasurywala, Arrowcan PartnersYu Zhang, CAPRA InternationalChristopher Paige, Shanghai-Toronto Institute

for Health Research

Moderator: David Shindler, BioDiscovery TorontoStuart Wilson, ISTPCanadaAdi Treasurywala, Arrowcan PartnersYu Zhang, CAPRA InternationalChristopher Paige, Shanghai-Toronto Institute

for Health Research

Page 84: From Research to Revenue IV: Capturing Business Opportunities in Asia

Biomedical Industry in Biomedical Industry in ChinaChina

Yu ZhangYu Zhang

CAPRA InternationalCAPRA International

December 3, 2008December 3, 2008

84

Page 85: From Research to Revenue IV: Capturing Business Opportunities in Asia

Here’s What I Will Cover TodayHere’s What I Will Cover Today

Current scenario of China’s biopharma Current scenario of China’s biopharma industry and underlying reasonsindustry and underlying reasons

Industry trends and what are shaping themIndustry trends and what are shaping them Examples of international collaborationsExamples of international collaborations

85

Page 86: From Research to Revenue IV: Capturing Business Opportunities in Asia

China is a Rapidly Growing China is a Rapidly Growing Biopharma Producer and Market …Biopharma Producer and Market …

>20% growth during 2001-05 to >$3bio; World 4>20% growth during 2001-05 to >$3bio; World 4thth largest vaccine marketlargest vaccine market

Home to >400 biopharmaceutical manufacturers incl. Home to >400 biopharmaceutical manufacturers incl. 114 for genetically engineered drugs and 28 for 114 for genetically engineered drugs and 28 for vaccinesvaccines

Driven by government policies:Driven by government policies: Huge increase in government investment: $100mio in 2001 Huge increase in government investment: $100mio in 2001

→ $1.2bio in 2005 → $1.2bio in 2005 Strong promotion of product development in China by Strong promotion of product development in China by

foreign companiesforeign companies

Sources: Biopharm International, Mar07; BioSpectrum Asia, Nov08; Sarah E Frew et al, Nature Biotechnology, Jan08

86

Page 87: From Research to Revenue IV: Capturing Business Opportunities in Asia

… … Even Though It Represents Even Though It Represents Only 7% of Global MarketOnly 7% of Global Market

In the past, limited innovative capabilities In the past, limited innovative capabilities and funding support for R&Dand funding support for R&D

Result: 90% of market is biogenericsResult: 90% of market is biogenerics However, CAGR is projected 22% during However, CAGR is projected 22% during

2005-2010 to reach $10.3bio2005-2010 to reach $10.3bio

Sources: Biopharm International, Mar07; Sarah E Frew et al, Nature Biotechnology, Jan08 87

Page 88: From Research to Revenue IV: Capturing Business Opportunities in Asia

Government Has Been Strongly Government Has Been Strongly Driving InnovationDriving Innovation

R&D policies and support have resulted in:R&D policies and support have resulted in: Having commercialized world’s 1Having commercialized world’s 1stst licensed gene licensed gene

therapy drugs:therapy drugs: Collaboration between Sunway and GenzymeCollaboration between Sunway and Genzyme

Developing leading-edge stem cell therapiesDeveloping leading-edge stem cell therapies Shanghai Genon Bio-EngineeringShanghai Genon Bio-Engineering

Developing novel therapies to treat both locally Developing novel therapies to treat both locally and globally relevant diseases:and globally relevant diseases:

Tianjin FusoGene’s HIV inhibitor granted US patentTianjin FusoGene’s HIV inhibitor granted US patent

88Sources: Websites; Sarah E Frew et al, Nature Biotechnology, Jan08

Page 89: From Research to Revenue IV: Capturing Business Opportunities in Asia

Continuous Government Commitment to Continuous Government Commitment to Biotech Leap ForwardBiotech Leap Forward

Biomedicine emphasized in the 11Biomedicine emphasized in the 11thth Five-Year Plan of Five-Year Plan of government (2006-2010)government (2006-2010)

Government investment will be $8.8bio by 2010Government investment will be $8.8bio by 2010 Principal Objectives: Principal Objectives:

To develop and commercialize 10-15 innovative drugs and To develop and commercialize 10-15 innovative drugs and vaccines with Chinese owned IP rightsvaccines with Chinese owned IP rights

To market 5 chemical synthetic finished drugs to western To market 5 chemical synthetic finished drugs to western countries by 2010countries by 2010

To foster 5 large-scale pharma groups, to promote 10 large To foster 5 large-scale pharma groups, to promote 10 large distributors , and to help 5 domestic pharma evolve into distributors , and to help 5 domestic pharma evolve into international enterprisesinternational enterprises

Source: Biopharm International, Mar07; BioSpectrum Asia, Nov08 89

Page 90: From Research to Revenue IV: Capturing Business Opportunities in Asia

Companies Have Benefited From Companies Have Benefited From Government-Supported LabsGovernment-Supported Labs

Genetically engineered vaccines: SinovacGenetically engineered vaccines: Sinovac Immunologic diagnostic reagents: Shanghai Immunologic diagnostic reagents: Shanghai

MedicilonMedicilon Pharmacogenomic and proteomic screening: Pharmacogenomic and proteomic screening:

Shanghai GenomicsShanghai Genomics QC technology in TCM industry: Shenzhen QC technology in TCM industry: Shenzhen

Tongjitang PharmaceuticalTongjitang Pharmaceutical Antibody drugs: Suzhou YES Biotech LaboratoriesAntibody drugs: Suzhou YES Biotech Laboratories Medical implant devicesMedical implant devices

Source: Notification from China’s National Development and Reform Commission (NDRC), Oct07; Company websites 90

Page 91: From Research to Revenue IV: Capturing Business Opportunities in Asia

Significant Government Support Significant Government Support in Other Biotech Research Areasin Other Biotech Research Areas

Breeding for endangered herbsBreeding for endangered herbs Molecular crop breedingMolecular crop breeding Cellular crop breedingCellular crop breeding Forest tree breedingForest tree breeding Animal breedingAnimal breeding Chemical applications on biomassChemical applications on biomass Veterinary biological productsVeterinary biological products Crop transgenic breedingCrop transgenic breeding Development and safety of biologic feedDevelopment and safety of biologic feed

91

Page 92: From Research to Revenue IV: Capturing Business Opportunities in Asia

Increasing Numbers of ‘Sea-Turtles’ Increasing Numbers of ‘Sea-Turtles’

Mean More International CollaborationsMean More International Collaborations Shanghai Genomics and Gene Networks Shanghai Genomics and Gene Networks

International International Shenzhen Chipscreen Biosciences and HUYA Shenzhen Chipscreen Biosciences and HUYA

Bioscience International in San DiegoBioscience International in San Diego Mindray Bio-Medical’s acquisition of Mindray Bio-Medical’s acquisition of

DataScope businessDataScope business June 3-4June 3-4thth: ChinaBio Partnering Forum in : ChinaBio Partnering Forum in

Shanghai: Shanghai: www.chinabiollc.com

92

Page 93: From Research to Revenue IV: Capturing Business Opportunities in Asia

China is Open for China is Open for Biopharma Business!Biopharma Business!

““Chinese biopharma enterprises are looking forward to Chinese biopharma enterprises are looking forward to more collaboration with the world’s leading more collaboration with the world’s leading biopharma institutions and companies. We expect to biopharma institutions and companies. We expect to achieve a win-win situation with our global partners. achieve a win-win situation with our global partners. The Chinese biopharmaceutical industry is ready to The Chinese biopharmaceutical industry is ready to make significant contributions to global disease make significant contributions to global disease prevention and healthcare.”prevention and healthcare.”

- Ms. Lifeng Wang, CEO of China National Biotech Group (CNBG), at - Ms. Lifeng Wang, CEO of China National Biotech Group (CNBG), at the 1the 1stst International China Biopharmaceutical Symposium (ICBPS), International China Biopharmaceutical Symposium (ICBPS), Beijing, Dec06Beijing, Dec06

93

Page 94: From Research to Revenue IV: Capturing Business Opportunities in Asia

UHN China Strategy

Christopher Paige, PhDVice President, ResearchUniversity Health Network

94

Research to RevenueDecember 3, 2008

Page 95: From Research to Revenue IV: Capturing Business Opportunities in Asia

UHN Global Ventures

“to seek preferred academic and

commercial partnerships”

95

Research Planning

Page 96: From Research to Revenue IV: Capturing Business Opportunities in Asia

• Enhance Drug Development Capacity

• Build Clinical Research/Trial Capacity

• Extend Global Reach

96

WHY?

Page 97: From Research to Revenue IV: Capturing Business Opportunities in Asia

97

STRUCTURE

UHN Shanghai

Incorporated in China as a WFOE

97

UHN Shanghai CRO (Zhangjiang HT Park)

Page 98: From Research to Revenue IV: Capturing Business Opportunities in Asia

Profit expectations

A culture of “work - arounds”

Fast changing regulatory environment

98

Challenges

Page 99: From Research to Revenue IV: Capturing Business Opportunities in Asia

Service/development model

Get to know the Regulators

Hire good advisors

99

Solutions

关系

Page 100: From Research to Revenue IV: Capturing Business Opportunities in Asia

100

Thank You

谢 谢

Page 101: From Research to Revenue IV: Capturing Business Opportunities in Asia

Global Connections for Canadian InnovatorsLiaisons internationales pours les innovateurs canadiens

AN OVERVIEW OFISTPCANADA

December 3, 2008

Stuart Wilson, ISTPCanada

Page 102: From Research to Revenue IV: Capturing Business Opportunities in Asia

Background

International S&T Partnership Program $20 Million Program of Department of Foreign

Affairs and International Trade to foster international S&T partnerships

Target Countries: India, China, Brazil and Israel Israel component delivered by existing Canada-

Israel Industrial R&D Foundation (CIIRDF) India, China and Brazil components to be delivered

through non-governmental organizations

Page 103: From Research to Revenue IV: Capturing Business Opportunities in Asia

ISTPCanada Overview Established - January, 2007 Mandate – to promote and facilitate international R&D

partnerships involving Canadian companies and research organizations

Primary Activity - Implementing the funded program components of bilateral S&T agreements through counterpart organizations in partner countries

Clients – companies, academic institutes, research institutes and other institutes (Crown agencies may participate but cannot be recipient of funding)

Supported activities - Collaborative R&D Projects and Partnership Development Activities

Principles – S&T excellence, shared benefits, economic returns to both countries, symmetry, protection of IP, respect of local laws

Page 104: From Research to Revenue IV: Capturing Business Opportunities in Asia

Internal Partnerships

Provinces:• Alberta & British Columbia in place• Ontario & Quebec in development

Industrial Research Assistance Program (active) Ontario Centres of Excellence (active) Western Economic Diversification (active) Sustainable Development Technology Canada The Canadian Institutes of Health Research The Atlantic Canada Opportunities Agency Federal Science-based Departments and agencies

Page 105: From Research to Revenue IV: Capturing Business Opportunities in Asia

The Basic Approach

Synchronize application process with the implementing organization in the partner country, to the greatest extent possible

Common calls for proposals will be issued and syncronization of approval processes maximized; and

Final authority for funding rests with national implementing organizations but a Yes/Yes decision is required before proceeding.

Page 106: From Research to Revenue IV: Capturing Business Opportunities in Asia

Collaborative R&D Projects ~80% of ISTP program funds Industry participation essential Commercialization plan important element of proposals Academia and R&D Institutes participation encouraged

and may lead project Exchange of young researchers also encouraged Maximum contribution by ISTPCanada is $600,000 Contribution up to 50% Canadian share of eligible costs Average project duration 1-3 years Number of projects funded each call-for-proposals is

subject to available funding

Page 107: From Research to Revenue IV: Capturing Business Opportunities in Asia

Collaborative R&D Projects

Key Criteria: Scientific merits and degree of innovation inherent

in the product/service developed Business opportunity and capacity for commercial

success Capacity of participants to manage and conduct the

project, including commercialization thus leading to clear benefits to both countries

Non-government funding minimum of 25%

Page 108: From Research to Revenue IV: Capturing Business Opportunities in Asia

Application and Review Process

Competitive Process Expression of Interest (EOI in India but not in China) Invitation for full proposal submission Parallel proposal evaluations in each country: yes/yes

required At ISTPCanada

- Expert assessment- Advisory Committee recommendation- Joint project approval- ISTPCanada Board approval

Page 109: From Research to Revenue IV: Capturing Business Opportunities in Asia

Partnership Development Activities ~20% of program funds Joint cost-shared activities such as workshops,

partnering missions, seminars, conferences, symposia, exchanges, and other technology partnership events

Industry participation encouraged Objective to form extended R&D collaborations competitive calls and internally generated Up to $25,000 or 50% of eligible Canadian costs

Page 110: From Research to Revenue IV: Capturing Business Opportunities in Asia

China Update First CFP September, 2007

• 135 Expressions of Interest• 47 full proposals invited• 8 projects announced May, 2008

Second CFP September 2008• 170+ Expressions of Interest• 38 full proposals invited

Partnership Development Activities• 15 completed or approved

Page 111: From Research to Revenue IV: Capturing Business Opportunities in Asia

India Update First CFP Launched October, 2007

• 67 Expressions of Interest received• 29 Full proposals invited• 8 projects approved• For Partnership Development Activities (PDA)• Open Call for Proposals – 3 month turn-around• 3 PDAs being developed

Second CFP September (Biosciences)• 20+ Expressions of Interest

Partnership Development Activites• 3 completed or approved

Page 112: From Research to Revenue IV: Capturing Business Opportunities in Asia

Contacts

www.istpcanada.ca

Bharat Rudra – Country Manager, India• [email protected]

Stacy Chew – Country Manager, China• [email protected]

Page 113: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 114: From Research to Revenue IV: Capturing Business Opportunities in Asia

Adventures in Emerging MarketsAdventures in Emerging MarketsAndrea Mandel-CampbellAndrea Mandel-Campbell

Page 115: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 116: From Research to Revenue IV: Capturing Business Opportunities in Asia

Mississauga: Canada's3rd Largest Life Sciences ClusterMississauga: Canada's3rd Largest Life Sciences Cluster

Larry Petovello, City of MississaugaLarry Petovello, City of Mississauga

Page 117: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 118: From Research to Revenue IV: Capturing Business Opportunities in Asia

Strategic Case StudiesStrategic Case StudiesModerator: Joel Cheng, XPhase Pharmaceuticals Inc.Bin Huang, WEX PharmaceuticalsFulong Qiao, Beijing Farmunity Inc.Sean Thompson, YM Biosciences

Moderator: Joel Cheng, XPhase Pharmaceuticals Inc.Bin Huang, WEX PharmaceuticalsFulong Qiao, Beijing Farmunity Inc.Sean Thompson, YM Biosciences

Page 119: From Research to Revenue IV: Capturing Business Opportunities in Asia

Developing a new class of Developing a new class of non-opioid non-opioid analgesics for analgesics for

treatment of paintreatment of pain

by Bin Huang, President & CEOby Bin Huang, President & CEO

From Research to Revenue IVFrom Research to Revenue IVCapturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

December 3, 2008December 3, 2008

Page 120: From Research to Revenue IV: Capturing Business Opportunities in Asia

OVERVIEWOVERVIEWwww.wexpharma.comwww.wexpharma.com

Phase 3 clinical trial: Tectin for refractory cancer pain– NNew class of ew class of non-opioidnon-opioid analgesics analgesics – Clinical trials in Canada since 2000

A Canadian public company since 1992 – TSX:WXI– Management and development teams in Vancouver

and Montreal– Manufacture plant in Nanning, China

$20 million investment from CK Life Sciences– Deal closed October 2007, provides funding for 2

years– Rebuild management team

Page 121: From Research to Revenue IV: Capturing Business Opportunities in Asia

The Asia Connection The Asia Connection – WEX experience– WEX experience

Origin of Company – Hong Kong

Initial source of technology – China

API supply – 25 staff manufacture plant in Nanning, China

New major investor – CK Life Sciences Int’l, HQ in Hong Kong

Page 122: From Research to Revenue IV: Capturing Business Opportunities in Asia
Page 123: From Research to Revenue IV: Capturing Business Opportunities in Asia

Opportunities

Cost of R&DAccess to larger pools of patientsAccess to capital

– An alternative sourceAccess to large and rapidly-growing

market– Asian prevalent diseases– Inexpensive medicines– Diagnostic tools and services

Page 124: From Research to Revenue IV: Capturing Business Opportunities in Asia

Considerations

A constantly changing environment – Know the rules and culture

Virulent competition, pricing pressure– Government support for SOE vs. WFOE

Government – can’t rely on it, can’t defy it Local partner is critical Trusted advisor is essential Mind your store - feet on ground

– Hong Kong and Singapore are good gateways Watch your IP Get paid upfront

Page 125: From Research to Revenue IV: Capturing Business Opportunities in Asia

Examples

www.crownbio.com – CRO

www.wuxipharmatech.com – CMO

www.simcere.com – Pharma

www.caprainc.com – Partnerships

www.asialife.com – Venture consulting

Page 126: From Research to Revenue IV: Capturing Business Opportunities in Asia

Dr. Fulong Qiao

Beijing Farmunity Inc.

December 3, 2008

Integrated Eco-Dairy Corporation (IEDC) Model

Page 127: From Research to Revenue IV: Capturing Business Opportunities in Asia

Outline1. Best safe foods market in the world

2. Marketing strategy of safe foods in China

3. Challenging issues of Chinese dairy

4. Milestones of Fulong’s business in China

5. Highlights of integrated dairy producing technology

system (IDPTS)

6. Integrated eco-dairy corporation (IEDC) model

7. Strategies on development

8. Summary

Page 128: From Research to Revenue IV: Capturing Business Opportunities in Asia

1. Best safe foods market in the World

1. Facts in Chinese Agriculture:

1. China has 10% of arable lands vs. 20% of population in the World.

2. Lack of standardized production and economic land scale.

1. China has 250 million households (farms).

2. Each household has only 1 Acre arable land in average.

3. Farming is more and more relaying on chemicals.

1. 35% chemical fertilizers in the world are used in China.

2. Pesticides, herbicides, hormones and antibiotics are widely used.

2. Niche Market of Safe Foods:

1. Right now, people pay more attention on safe foods than education, social

warfare, environmental pollution and employment.

2. Limited choices of safe foods and 100 – 300% of premium.

3. 6% of families have more than 60% of the total assets in China.

Page 129: From Research to Revenue IV: Capturing Business Opportunities in Asia

2. Strategy of safe food marketing in China

1. Using superior dairy products to establish niche safe food

marketing network:

1. Dairy products are one of the most popular foods for those

consumers with higher family incomes.

2. Superior dairy products are rare in China.

3. In current markets, liquid milk products with reasonable good

quality have at least 150% of premium.

4. Logistic cost is reasonable for directly selling superior dairy

products with cold chain systems.

2. Adding on other safe foods to the established marketing

network:

1. Importing and marketing safe foods and feed

2. Integrating existing producers to produce high quality animal

products, vegetables, special superior grains and fruits.

Page 130: From Research to Revenue IV: Capturing Business Opportunities in Asia

3. Challenging issues of Chinese Dairy

1. Overall poor dairy management

2. Low quality products

3. Unsustainable dairy industry

Page 131: From Research to Revenue IV: Capturing Business Opportunities in Asia

3.1 Overall poor dairy management

1. Lack of practical dairy barn design

1. Cows are directly lying on the hard floor.

2. Cows are suffering strong cold wind in winter and serious heat stress in summer.

3. Lack of good water supply system.

4. Lack of calving pens.

5. Poorly constructed silage buck silos.

2. Lack of high quality forage (feeding cows like pigs)

3. Inferior genetics, lack of systematic breeding program

4. Poor managements of disease control, untrained labor and milking unsanitary

5. Extremely high incidences of mastitis, lameness and reproduction infections

6. Heavily contaminated raw milk

1. Serious bacteria contamination: millions/ml

2. Serious issues of adulterated milk

3. Antibiotic contamination

Page 132: From Research to Revenue IV: Capturing Business Opportunities in Asia

3.2 Poor quality products

Criteria Advanced Countries

China

Processing temperature (oC) 72-75 |135 85 |135-150

Processing time (seconds) >15 | 2-5 >16 | 4 -15

Reconstituted milk? No >30% (before 2007)

Nutrient value Superior Low

Package cost (percentage of retail price)

10% 20 - 40%

Advertisements Little5 – 10% of sale revenue

Page 133: From Research to Revenue IV: Capturing Business Opportunities in Asia

3.3 Unsustainable dairy industry

1. Not win-win biz model of ‘Dragonhead Processors + Milking Stations

+ Farmers’

Farmers Milking Stations Processors

Small Poor facility Over-heat milk

Lack of organization Poor management High package cost

Feed cows as pigs Disease spreading site High ad. cost

Poor disease control Highly contaminated milk Cheating concepts

Inferior genetic Making money by adulteration

High risk and low return

Helpless

2. Unsustainable development, low quality competitions

Page 134: From Research to Revenue IV: Capturing Business Opportunities in Asia

4. Milestones of Fulong’s business in China

1. 2004-2005:

1. Integrated dairy producing technology system (IDPTS) had been

developed, which was officially evaluated on June 6, 2006, Beijing.

2. Dairy producing studies had been conducted across China.

2. 2006-2007:

1. The first cooperative dairy farm was accomplished in April’07, Huhhot.

2. The IDPTS had been implemented in Beijing, Hebei and Inner Mongolia.

3. 2008:

1. The kernel IEDC model is initiated in Beijing.

2. Superior dairy products will be produced and marketed in Beijing.

Page 135: From Research to Revenue IV: Capturing Business Opportunities in Asia

1. Examples of the innovative technologies of the IDPTS

2. Practical achievements in Beijing, Hebei and Inner Mongolia

5. Highlights of the IDPTS

Page 136: From Research to Revenue IV: Capturing Business Opportunities in Asia

1. Feeding cows with high quality and low cost forage based rations

Forage producing cooperatives Heavy machinery operation Less labors and high efficiency High quality and low cost forage

5.1 Examples of the innovative technologies of the IDPTS

Page 137: From Research to Revenue IV: Capturing Business Opportunities in Asia

2. Comfort and clean bedding systems

5.1 Examples of the innovative technologies of the IDPTS

Page 138: From Research to Revenue IV: Capturing Business Opportunities in Asia

5.2 Practical achievements of implementing the IDPTS

After 3 months

After 3 months

Page 139: From Research to Revenue IV: Capturing Business Opportunities in Asia

1. Increase milk yield 20 – 50%

2. Increase milk price with high quality

3. Double the longevity of cows

4. Added profit is about 4000 – 9000 RMB per

lactating cow per year

5.2 Practical achievements of implying the IDPTS

Page 140: From Research to Revenue IV: Capturing Business Opportunities in Asia

6. Integrated Eco-Dairy Corporation (IEDC) Model

1. Introduction of IEDC Model

2. “N+1”Kernel IEDC Model

Page 141: From Research to Revenue IV: Capturing Business Opportunities in Asia

6.1 Introduction of IEDC Model

1. Integration from developing forage producing cooperatives, revising

and managing existing dairy farms, OEM milk processing, and direct

marketing.

1. 100% well controlled quality assurance system.

2. Loyal consumers.

2. Forage producing cooperatives

1. Exploring economics in scale by using heavy machinery instead of

traditional labor intensive farming.

2. Producing high quality and low cost forage.

3. Revising and managing existing larger dairy farms

1. Minimizing capital investment and dairy farming risks.

2. Healthy cows & superior raw milk.

4. OEM milk processing

1. Minimizing capital investment and production cost by using existing

plants.

2. Direct marketing high quality dairy products with reasonable prices.

Page 142: From Research to Revenue IV: Capturing Business Opportunities in Asia

ForageEco-Producing

Cooperative

Forage Eco-Producing

Cooperative

Forage Eco-Producing Cooperative

Forage Eco-Producing Cooperative

High quality forage based rationsComfort bedding systemsSexed Semen & Embryo Transfer Advanced Milking FacilityTMR Supply FacilityWaste ManagementSemi-quarantine disease control

Regional Centre

Management & Service Centre

OEM Dairy Processing

Dairy Farm

Dairy Farm

Dairy FarmDairy Farm

6.2“N+1”Kernel IEDC Model

Page 143: From Research to Revenue IV: Capturing Business Opportunities in Asia

7. Development strategies

1. The primary goals are to fulfill the kernel IEDC model in

Beijing between 2008 – 2010.

1. The number of lactating cows is 5,000.

2. Producing, processing and marketing 100 tones of milk

a day.

3. Serve 300,000 – 400,000 consumers with memberships.

2. The optimal goals are to supply other superior foods to

those membership consumers by importing and

integrating existing producers and processers.

Page 144: From Research to Revenue IV: Capturing Business Opportunities in Asia

8. Summary

1. Integrated dairy producing technology system (IDPTS)

1. Minimize the technical risks

2. Produce superior milk

3. Maximize profits

2. Establishing direct-sale marketing network by using IEDC

model

1. Overcome all of challenging issues that farmers and consumers are

facing.

2. Optimize the interests of farmers, local governments, consumers and

investors

3. Marketing wide range of safe foods produced

1. IEDC model will be multiplied in other sectors.

2. High return, which can satisfy all of the participants.

3. Good for people, nature and society.

Page 145: From Research to Revenue IV: Capturing Business Opportunities in Asia

advancing drugs effectively

S. Korea

Japan

Australia

Singapore

Indonesia

EU

USA

Canada

Q4/2008

Sean Thompson

VP Corporate Development

Research to Revenue IV

Mississauga Living Arts Centre

December 3, 2008

Page 146: From Research to Revenue IV: Capturing Business Opportunities in Asia

Safe Harbor Statement

This presentation may contain forward-looking statements, which reflect the Company's

current expectation regarding future events. These forward-looking statements involve

risks and uncertainties that may cause actual results, events or developments to be

materially different from any future results, events or developments expressed or implied

by such forward-looking statements. Such factors include, but are not limited to, changing

market conditions, the successful and timely completion of clinical studies, the

establishment of corporate alliances, the impact of competitive products and pricing, new

product development, uncertainties related to the regulatory approval process and other

risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

Certain of the assumptions made in preparing forward-looking statements include but are

not limited to the following: that nimotuzumab will continue to demonstrate a competitive

safety profile in ongoing and future clinical trials; that AeroLEF® will continue to generate

positive efficacy and safety data in future clinical trials; and that YM and its various

partners will complete their respective clinical trials within the timelines communicated in

this release. We undertake no obligation to publicly update or revise any forward-looking

statements, whether as a result of new information, future events or otherwise.

Page 147: From Research to Revenue IV: Capturing Business Opportunities in Asia

> YM BioSciences is a biopharmaceutical development company engaged in commercialization of products principally for cancer patients. We have 33 employees and are based in Mississauga, Canada

> Portfolio consists of two late-stage products: Nimotuzumab, a monoclonal antibody for cancer and AeroLEF®, an opioid product for acute post-operative pain

> Recent management changes implemented to aggressively advance development of the portfolio

• Net cash ~$52 million*, Net cash/share ~ $1 – No debt – No impaired assets

• Burn rate for FY’08 ~$17.5 million**• Shares outstanding: ~ 58 million*** / ~ 71 million f.d.• NYSE/Alternext – YMI; TSX – YM; AIM - YMBA

* Estimate as @ September 30, 2008 ** To increase with clinical activity*** 2.5 million of these are subject to milestones including partnership and Phase III initiation of AeroLEF®

Investment Summary

Page 148: From Research to Revenue IV: Capturing Business Opportunities in Asia

>Uniquely permits patient self-titration of opioids:

• Fentanyl is first product

• Soft mist inhalation with an approved nebulizer

• New management team with established fentanyl development and regulatory experience mandated to partner product

AeroLEF®

Page 149: From Research to Revenue IV: Capturing Business Opportunities in Asia

>Clinically demonstrated to be an active drug in multiple tumor types

>Mechanistically demonstrated to be differentiated from cetuximab (Erbitux®) and panitumumab (Vectibix®)

>Being developed by a global consortium of companies

>Marketed in numerous secondary markets including:• India, China, Philippines, Indonesia

Nimotuzumab – Affinity-Optimized™ Anti-EGFR mAb

Page 150: From Research to Revenue IV: Capturing Business Opportunities in Asia

>Med-High EGFR environment (cancer cells): all mAbs bind in the same manner—bivalently1

• Evidence of equivalent therapeutic efficacy of nimotuzumab to higher affinity mAbs (clinical/preclinical)

>Low EGFR environment (normal cells): high affinity antibodies (cetuximab and panitumumab) bind tightly and monovalently

• Results in indiscriminate activity and toxicity

>Nimotuzumab’s affinity optimization results in transient monovalent binding and stable bivalent binding

• Differentiates between normal and cancer cells

1 Yoshida et al 2008; Tikhomirov et al 2008; van Bueren et al 2008

Nimotuzumab Therapeutic Effect Concentrated at Tumor

Page 151: From Research to Revenue IV: Capturing Business Opportunities in Asia

NimotuzumabAffinity-Optimized™ mAb

High Affinity anti-EGFR mAbs

Activity of Nimotuzumab is Concentrated at Tumor

Activity of High Affinity anti-EGFR mAbs is dispersed across all

tissues, causing toxicity

Tumor(High EGFR)

Tumor(High EGFR)

Nimotuzumab – Mechanistically Differentiated

Page 152: From Research to Revenue IV: Capturing Business Opportunities in Asia

Erbitux® plus Radiation

Nimotuzumab plus

Radiation

Vectibix® plus BSC

BSCAlone

Rash - Grades 3 and 4

25%2 VERY RARE 62%3 0%

Rash - All grades 87% 9% 90% 6%

Rad. Dermatitis—Grades 3 and 4

49%5 VERY RARE NA NA

Pruritus 16% VERY RARE 57% 2%

Hypomagnesemia – all grades

55%4 VERY RARE 39% 2%

Nausea 49% 22% 23% 16%

Diarrhea 19% 9% 21% 1%

Constipation 35% 14% 21% 9%

Vomiting 29% 14% 19% 12%

1 Information from four completed trials; data collection ongoing.2 FDA Action Letter, June 2008 3 STEPP trial – 2008 – 29% post-preemptive treatment

4 Erbitux® Package insert. Revised: 11/20085 Article in Press: Giro C et al, Radiother Oncol (2008),

doi:10.1016/j.radonc.2008.09.007

Erbitux® and Vectibix® Have Significant Toxicities

Page 153: From Research to Revenue IV: Capturing Business Opportunities in Asia

> Affinity-optimized™ nimotuzumab has potential for significantly improved therapeutic window relative to Erbitux® and Vectibix®

• Lower affinity for normal cells (skin and kidney) vs. Erbitux®1

• No evidence of Grade III/IV kidney toxicity (hypomagnesemia)2

• No evidence of Grade III/IV skin toxicity2

> There is no clinical evidence of serious toxicity in chemoradiation regimens (RT+CisPt) with addition of nimotuzumab

• With Erbitux®, 20% treatment discontinuation in combination CisPt/RT regimen previously reported3

> The only anti-EGFR mAb tolerable for chronic use – therapeutic window crucial - and the drug of choice for combination Chemo+RT

1 Internal unpublished data2 Nimotuzumab integrated global safety database3 Erbitux® Package Insert

Nimotuzumab – Uniquely Positioned Anti-EGFR mAb

Page 154: From Research to Revenue IV: Capturing Business Opportunities in Asia

NSCLC Palliative Phase I/IISingle-armPatients unsuitable for radical therapy

ASCO June 2008 & Preliminary data on 2nd cohort

Substantial radiological responses and meaningful clinical responses in each cohort. Median survival of three cohort equals 60 weeks.

Brain Metastases from NSCLC

Randomized Phase II RT +/- nimotuzumab

Preliminary analysis (EORTC/NCI/AACR October 2008)

CR+PR+SD 92% vs. 44%OS 7 months vs. 2.5 months

H & N Stage III & IVA unresectable(BEST trial)

Multi-modal 4-arm Phase II CT/CRT +/- nimotuzumab

Marketing Approval by Health Regulatory Authorities in India

Significant tumor response rates (CR/ORR) compared to RT alone and to CT + RT alone.

Nasopharyngeal Randomized Phase II RT +/- nimotuzumab

Marketing Approval by Health Regulatory Authorities in China

CR 91% vs. 52% at 17 weeks

H & N (locally advanced)

Phase II single-arm100 and 200 mgs

In publication Twenty patients (83%) – CR or PR. The median overall survival (n=24) was 51.7 months.

Glioma GBM Stratum

Phase III RT +/- nimotuzumab

Interim analysis of 65/80 patients to complete the trial

Overall survival placebo+ RT = 8.67 months

Nimotuzumab + RT = 16.43 months

Clinical Evidence >30 Trials in Ten Tumor Types

Page 155: From Research to Revenue IV: Capturing Business Opportunities in Asia

Multiple randomized trials ongoing in 2009

DIPGPhase IIIrecruitment completed

Adult GliomaPhase IIIrandomized, controlled

PancreaticPhase IIb/IIIarandomized, controlled

Europe

GastricPhase IIrandomized

Other indications planned

Japan and Korea

Brain Metastases (NSCLC)

Phase IIrandomized, controlled

Non-Small Cell LungPhase IIrandomized, controlled

DIPG Phase IIOpen label

North America

Nimotuzumab – Path to Approval in Major Markets

Page 156: From Research to Revenue IV: Capturing Business Opportunities in Asia

Nimotuzumab – Preferential Positioning

Indication5 yr

Survival

European Patients

Japanese Patients

NA Patient

s

Glioblastoma 25% 12,600 1,000 4,800

NSCLC 15% 229,000 52,000 166,000

Brain Mets (NSCLC)

15% 71,000 16,200 52,000

H&N 60% 98,000 15,000 42,000

Esophageal 16% 48,000 14,000 16,000

Gastric 25% 171,000 114,000 29,000High Unmet Need – Low 5 Year Survival

Large Markets – More than 1 million patients globally

Target indications driven by mechanistic and clinical observations

Page 157: From Research to Revenue IV: Capturing Business Opportunities in Asia

Nimotuzumab – YM Global Marketing Rights

YM BioSciences nimotuzumab marketing rights

Japan

Korea

Australia/New Zealand

North America

Southeast Asia

Europe

Africa

Page 158: From Research to Revenue IV: Capturing Business Opportunities in Asia

Licensee Territory Date Market Approval Indication

S Korea Jun-05 not filed  

SE Asia Nov-05 Indo, Philippines Glioma (08)

Japan Jul-06 not filed  

India, PK Jun-04 India H&N (06)

Nimotuzumab – Business Development in Asia

Page 159: From Research to Revenue IV: Capturing Business Opportunities in Asia

Why Asia?

> Early revenue for company

> Additional resources for development

> Broaden label faster, some conditions endemic in Asia

> Open minded executives. Less influenced by cross pollination in US and EU companies

> Broaden company revenue base

> An excellent method to build Canadian based companies!

Page 160: From Research to Revenue IV: Capturing Business Opportunities in Asia

Ongoing trial Completed trial

Indication Phase I Phase II Phase III Sponsor

Pediatric Diffuse Intrinsic Pontine Glioma Phase III trial reporting mid-2008 Oncoscience AG

Adult Glioma Oncoscience AG

Pancreatic Cancer Oncoscience AG

Head & Neck Cancer YM BioSciences

Pediatric Glioma (High Grade) Phase II data submitted to EMEA Oncoscience AG

Pancreatic Cancer Oncoscience AG

Pediatric Diffuse Intrinsic Pontine Glioma YM BioSciences

Colorectal Cancer YM BioSciences

Non-Small Cell Lung Cancer YM BioSciences

Japanese Safety Study Daiichi-Sankyo

Pharmacodynamic Study YM BioSciences

Esophageal Cancer CIM / Eurofarma

Squamous Cell Carcinoma of the Head & Neck Innogene Kalbiotech

Gastric Cancer (Advanced, Recurrent) Daiichi-Sankyo/Kuhnil

Pediatric Brain Stem Tumors YM BioSciencesExpanded Access Program - USA

Nimotuzumab Clinical Trials

Page 161: From Research to Revenue IV: Capturing Business Opportunities in Asia

> YM BioSciences is a biopharmaceutical development company engaged in commercialization of products principally for cancer patients. We have 33 employees and are based in Mississauga, Canada

> Portfolio consists of two late-stage products: Nimotuzumab, a monoclonal antibody for cancer and AeroLEF®, an opioid product for acute post-operative pain

> Recent management changes implemented to aggressively advance development of the portfolio

• Net cash ~$52 million*, Net cash/share ~ $1 – No debt – No impaired assets

• Burn rate for FY’08 ~$17.5 million**• Shares outstanding: ~ 58 million*** / ~ 71 million f.d.• NYSE/Alternext – YMI; TSX – YM; AIM - YMBA

* Estimate as @ September 30, 2008 ** To increase with clinical activity*** 2.5 million of these are subject to milestones including partnership and Phase III initiation of AeroLEF®

Investment Summary

Page 162: From Research to Revenue IV: Capturing Business Opportunities in Asia

S. Korea

Japan

Australia

Singapore

Indonesia

EU

USA

Canada

advancing drugs effectively

Page 163: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 164: From Research to Revenue IV: Capturing Business Opportunities in Asia

Impact of Regulations:How They Affect People on the GroundImpact of Regulations:How They Affect People on the Ground

Moderator: John Kelly, MaRS LandingValerie Bell, Bell Alliances InternationalAshley Roberts, CantoxXuefeng Yu, sanofi pasteurPaul Jones, Jones & Company

Moderator: John Kelly, MaRS LandingValerie Bell, Bell Alliances InternationalAshley Roberts, CantoxXuefeng Yu, sanofi pasteurPaul Jones, Jones & Company

Page 165: From Research to Revenue IV: Capturing Business Opportunities in Asia

Bio-Pharmaceutical Bio-Pharmaceutical Regulations in ChinaRegulations in China

Page 166: From Research to Revenue IV: Capturing Business Opportunities in Asia

China Biotech landscapeChina Biotech landscape

Biotechnology is one of the seven key Biotechnology is one of the seven key technologies for the national science technologies for the national science and technology medium- and long-and technology medium- and long-term development plan (2006-2020)term development plan (2006-2020)

Multiple sources of FundingMultiple sources of Funding• MOST, DOH, NDRC, Local GovernmentMOST, DOH, NDRC, Local Government

S&T Industrial Park attracts most of S&T Industrial Park attracts most of the new Biotech industries the new Biotech industries

Page 167: From Research to Revenue IV: Capturing Business Opportunities in Asia

Distribution of S&T Industrial park Distribution of S&T Industrial park

Page 168: From Research to Revenue IV: Capturing Business Opportunities in Asia

Policies to regulate and promote Policies to regulate and promote BiotechnologiesBiotechnologies

Strategy for Biotech and Bio-Industry Strategy for Biotech and Bio-Industry development 2006-2020development 2006-2020

Bio-safety ActBio-safety Act Regulations for Human Genetic Regulations for Human Genetic

Resource ManagementResource Management Regulation on Biological Safety Regulation on Biological Safety

administration of Pathogenic administration of Pathogenic Microorganism Laboratories Microorganism Laboratories

Page 169: From Research to Revenue IV: Capturing Business Opportunities in Asia

Current Status of Biotech Industry in Current Status of Biotech Industry in ChinaChina

MNCs move in fastMNCs move in fast• Drug Discovery: R&D Centers + CRODrug Discovery: R&D Centers + CRO• MNCs began to acquire local Biotech Companies: GSKMNCs began to acquire local Biotech Companies: GSK

Local Biotech less innovativeLocal Biotech less innovative• Biotech > 90% on bio-similar productsBiotech > 90% on bio-similar products

Weak in “D”: Bioprocess and Development Weak in “D”: Bioprocess and Development Barrier and less trust to Foreign companiesBarrier and less trust to Foreign companies The Status is changing fastThe Status is changing fast

• MNC’s China strategyMNC’s China strategy• Significant amount of new Start-ups by oversea Significant amount of new Start-ups by oversea

returneesreturnees• Some local Biotech companies start recruiting top Some local Biotech companies start recruiting top

management from oversea. management from oversea.

Page 170: From Research to Revenue IV: Capturing Business Opportunities in Asia

Regulatory Challenges Regulatory Challenges

Government regulations lag behind the industry’s Government regulations lag behind the industry’s

needsneeds

• Significant delay for IND and NDA approvalSignificant delay for IND and NDA approval

• Regulatory authorities are mainly from academia, lack of Regulatory authorities are mainly from academia, lack of

experience to handle the biotech industry needs experience to handle the biotech industry needs

• Lack of coordination between government agencies, unclear Lack of coordination between government agencies, unclear

roles and responsibilitiesroles and responsibilities

• Different quality standard and interpretation of quality Different quality standard and interpretation of quality

standardstandard

• Barriers for new biotech products developed outside of China Barriers for new biotech products developed outside of China

Page 171: From Research to Revenue IV: Capturing Business Opportunities in Asia

OpportunitiesOpportunities Strong Support from GovernmentStrong Support from Government

• Strategy, Policy, FinanceStrategy, Policy, Finance Unique resources: Diseases and PatientsUnique resources: Diseases and Patients

• Strains, Blood samples, Patients and Subjects, Strains, Blood samples, Patients and Subjects, Talent PoolTalent Pool

• Scientists, Technicians, Logistic manpowerScientists, Technicians, Logistic manpower Low cost with high efficiencyLow cost with high efficiency

• Ph.D and Post-doctor 350-500 Euro/mPh.D and Post-doctor 350-500 Euro/m CRO CRO

• Animal Test: Rodent, Canine, Monkey, 11 facilities got AAALAC Animal Test: Rodent, Canine, Monkey, 11 facilities got AAALAC accreditationaccreditation

• Genomics, proteomics, pharmacology, pharmacokinetics, Genomics, proteomics, pharmacology, pharmacokinetics, toxicology, Pilot, etc.toxicology, Pilot, etc.

Increasing Medical needs, Future MarketIncreasing Medical needs, Future Market• 800M Euro in 2007, >30%/year800M Euro in 2007, >30%/year

Page 172: From Research to Revenue IV: Capturing Business Opportunities in Asia

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

www.cantox.com

CHINESE FOOD REGULATORY REQUIREMENTS

Ashley Roberts, Ph.D.Cantox Health Sciences International

From Research to Revenue IV: Capturing Business Opportunities in Asia

Mississauga Living Arts Centre, Mississauga, OntarioDecember 3, 2008

Page 173: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

INTRODUCTIONS

• Great interest in China from food, food ingredient and supplement manufacturers– Market expansion– Market size– Westernization– Changing dietary patterns

• Barrier to market– Knowledge of regulations– Requirements– Previous approvals (JECFA)

Page 174: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

CHINESE REGULATIONS

• Food laws established in 1949

• Revised in the 80’s– Food hygiene– Safety of imported foods

• Food Hygiene Law finalized in 1995– “To ensure food hygiene, prevent food

contamination or harmful substances from injuring human health, safeguard the health of the people and improve physical fitness”.

Page 175: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

FOOD HYGIENE LAW (1995)

• Law consists of 9 chapters and 57 articles– Hygiene for all foods– Food additives– Containers– Packages– Utensils– Equipment used for foods

• Production facilities also covered

• Covered by national, provincial and municipal governments

Page 176: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

FOOD HYGIENE LAW (1995)

• Outlines regulatory requirements for approval of domestic and imported products– Food additives– Novel foods– Functional foods– Supplements

• Individual regulations

HealthFoods

Page 177: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

FOOD ADDITIVES AND NOVEL FOODS APPROVAL

Unique System

• Positive list published in “Food Additive Hygiene Standard”

• Requires approval from Ministry of Health (MOH)

• Testing of food ingredient (analytical)

• Testing of food ingredient (toxicity)

• Results must be included in application

• Overseas, applicants need a representative officer or authorized agent

Page 178: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

HEALTH FOODS

• Require registration with the State Food and Drug Administration

• Can carry a health claim– No reference to treatment or cure of

disease

• Needs to be sold overseas for a period of 1 year

• Determine specific testing

• Examine manufacturing site (GMP)

• Approval valid for 5 years

Page 179: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

CONCLUSIONS

Marketing Acceptance

• Regulatory requirements for supporting safety

• Testing of materials (analytical/toxicology)

• Prior approvals required

• Chinese representative assistance

• “regulatory acceptance”

Page 180: From Research to Revenue IV: Capturing Business Opportunities in Asia

www.cantox.com

Consultants in

Human Health,

Toxicology &

Regulatory Affairs

BOOK CHAPTER

• CHINESE APPROACH ON REGULATING FOOD ADDITIVES, NOVEL FOODS, FUNCTIONAL FOODS, AND DIETARY SUPPLEMENTS

• Nutraceuticals and Functional Foods Regulations in the United States and Around the Worldhttp://www.elsevier.com/wps/find/bookdescription.cws_home/715494/description#description

Page 181: From Research to Revenue IV: Capturing Business Opportunities in Asia

181181181

INTELLECTUAL PROPERTY PROTECTION IN CHINA:

Best Practices

知识产权的保护在中国 :最佳做法

Paul JonesJones & Co. 钟保禄律师事务所 Джоунс и Ко.

www.jonesco-law.ca

Research to RevenueThe Biotechnology Initiative

December 3, 2008

Page 182: From Research to Revenue IV: Capturing Business Opportunities in Asia

182

简介 - Introduction

• Many foreigners believe that their intellectual property cannot be protected in China

• Consequently they are reluctant to register their IP rights in China

Page 183: From Research to Revenue IV: Capturing Business Opportunities in Asia

183

简介 - Introduction

• China has IP laws that meet international standards

• Chinese courts do enforce IP rights, and particularly IP rights held by foreign parties

• To a large extent the threat to IP from counterfeiters can be costed and managed

Page 184: From Research to Revenue IV: Capturing Business Opportunities in Asia

184

简介 - Introduction - 假冒伪劣 - Counterfeiting

“… a tumultuous period in which the rigid hierarchies of colonial times finally dissolved, replaced by the more fluid social order of a democratic commercial society. Self-fashioning and self-advancement slowly became a viable way of life…”

Stephen Mihm, A Nation of Counterfeiters, p.24

Page 185: From Research to Revenue IV: Capturing Business Opportunities in Asia

185

法院及知识产权的实施Courts & IP Enforcement Lego Case - 英特莱格公司( INTERLEGO . AG ) v. 可高(天津)玩具有限公司 ,

Beijing 2002

Lego was successful under design patent and copyright law

Beijing Higher People’s Court stated:

可高公司的产品确有抄袭之嫌,但同时也应看到英特莱格公司的上述玩具积木块艺术创作程度确实不是很高,与典型的实用艺术作品在艺术创作程度上尚有一定差距,一审法院出于平衡利益关系的考虑,作出上述认定是合理的,本院予以支持。

(While the Kegao Company’s products really have the smell of plagiarism, we should also consider that the level of artistic creation in the English Interlego Company’s products is not really very high and there is a certain disparity between it and typical practical works of art. The court of first instance struck a balance a reasonable balance of the interests and we will support it.)

Page 186: From Research to Revenue IV: Capturing Business Opportunities in Asia

186

简介 – Introduction – 政府 - Government

1. Unitary State – 31 “Provinces”• Each level of government can exercise the same

powers as the national government • if there is no conflict with the laws of a superior

level of government

2. Consultative Administration• Broad consultations on new laws• Reluctance to be the nail that sticks out

Page 187: From Research to Revenue IV: Capturing Business Opportunities in Asia

187187

最佳做法 – BEST PRACTICES

1. Register your IP• Trademarks

- as many classes as possible

- develop Chinese character version of mark• Patents

- Do both invention and utility applications- Search Chinese language prior art

• Copyrights- Consider registration to improve damage claims

Page 188: From Research to Revenue IV: Capturing Business Opportunities in Asia

188

商标在中国 – Trade-marks in China

麦当劳 – McDONALD’S (mai dang lao)

Mai – cover up, bury – 埋- buy, purchase – 买- step, stride, advanced in years – 迈- wheat, a surname – 麦- sell – 卖- arteries and veins – 脉

Page 189: From Research to Revenue IV: Capturing Business Opportunities in Asia

189

商标在中国 – Trade-marks in China

麦当劳 – McDONALD’S (mai dang lao)dang – equal, ought to, just at, work as, deserve, manage, sound of a

gong – 当- keep off, block, a fender, gear of a car – 挡- political party, the Party (Communist) – 党- earring, eunuch – 垱- crotch – 裆- proper, match, treat as think, that very day, to pawn – 挡- manure pit – 凼- loose in morals, a marsh – 荡- delay – 宕- outspoken – 谠

Page 190: From Research to Revenue IV: Capturing Business Opportunities in Asia

190

商标在中国 – Trade-marks in China

麦当劳 – McDONALD’S (mai dang lao)lao – scoop up from a liquid, get by improper means – 捞

- enclosure for animals, jail – 牢- work, reward – 劳- old, tough, dark – 老- waterlogged – 涝- bake in a pan – 烙- kind of farm tool – 耢- fruit jelly – 酪

Page 191: From Research to Revenue IV: Capturing Business Opportunities in Asia

191

商标在中国 – Trade-marks in China

麦当劳 – McDONALD’S – wheat should work

Other Possible Names:卖凼涝 – to sell something that has been

waterlogged in a manure pit

买挡捞 - to buy in order to prevent someone scooping something (perhaps improperly)

Page 192: From Research to Revenue IV: Capturing Business Opportunities in Asia

192

辉瑞商标的问题 Pfizer’s Trade-mark Problems

Pfizer – VIAGRA

最出名的药物万艾可 ( 伟哥、威而钢 )

Page 193: From Research to Revenue IV: Capturing Business Opportunities in Asia

193193

最佳做法 – BEST PRACTICES

2. Prepare a Business Plan for China• Select what will be made in China carefully – perhaps

withhold the most innovative or high-margin products, or separate functions so that no one manufacturer makes the whole product

• Make sure that your project is economically feasible – for you and potential partners

• Build monitoring and enforcement costs into your project feasibility plan

• Know your limit on losses from the project in advance, do a thorough risk analysis

Page 194: From Research to Revenue IV: Capturing Business Opportunities in Asia

194194

最佳做法 – BEST PRACTICES

2. Prepare a Business Plan for China

• Pricing and Channels of Distribution

– For products with broad consumer appeal in China many purchases are made in small retail shops – difficult to monitor and police

– Consider developing a stripped-down, low-cost version of the product for sale in China

Page 195: From Research to Revenue IV: Capturing Business Opportunities in Asia

195195

最佳做法 – BEST PRACTICES

3. Audits – Know What is Going to China• What are the key commercial elements?• How are they protected?

– Invention patent – utility patent – design patent – copyright– trade secret– trademark

• How valuable are they? Are they older items that have largely become known?

Page 196: From Research to Revenue IV: Capturing Business Opportunities in Asia

196196

最佳做法 – BEST PRACTICES

4. Find the Right Partner in China

• Retain advisors experienced in China

• Conduct searches through networks, look for introductions

• Attend trade conferences in China, get to know your options and the differences in your industry in China

Page 197: From Research to Revenue IV: Capturing Business Opportunities in Asia

197197

最佳做法 – BEST PRACTICES

4. Find the Right Partner in China – cont’d.

Conduct Due Diligence:

• Insist upon the right to make background checks on key people and the company

• Conduct checks on the reputation of the local area.

• Hire outside investigators, and use them

• Audit the other side - Carefully evaluate any property contributions by your Chinese partner, disputes over property valuation have plagued joint ventures

• Some prefer partners with foreign trained key personnel

Page 198: From Research to Revenue IV: Capturing Business Opportunities in Asia

198198

最佳做法 – BEST PRACTICES

4. Find the Right Partner in China – cont’d.

Conduct Due Diligence:

– Know if there is any state interest in the other party

• Does the other party need higher authorization to enter into the contract?

• Does the other party truly own the assets that it is contributing, or does the state still have an interest in the assets – e.g. Danone and the Wahaha trademark – “ 娃哈哈”

Page 199: From Research to Revenue IV: Capturing Business Opportunities in Asia

199199

最佳做法 – BEST PRACTICES

5. Structure the Deal Carefully

• License, technology transfer, co-operative joint venture, equity joint venture, WFOE?

• What is Plan B – if things don’t work out?

• How to get your money out of China – dividends, payment for services, royalties

– Withholding taxes on royalties now 10%

Page 200: From Research to Revenue IV: Capturing Business Opportunities in Asia

200200

最佳做法 – BEST PRACTICES

6. Develop a Good Contract

General Items

– Do not use your standard form agreement for North America

– Consider preparing for enforcement in China with a civil law form of contract in Chinese

– Do not rely on the other party as to the legal validity of the terms

– Negotiate in good faith and disclose material facts – required by Article 42 of the Contract Law ( 中华人民共和国合同法 )

Page 201: From Research to Revenue IV: Capturing Business Opportunities in Asia

201201

最佳做法 – BEST PRACTICES

6. Develop a Good Contract – cont’d.

– IP Issues • Carefully describe the scope of the grant – for

example – territorially what is China?

• Rights to improvements – remember the restrictions on grantbacks

• How will access to the IP be controlled, monitored?

Page 202: From Research to Revenue IV: Capturing Business Opportunities in Asia

202202

最佳做法 – BEST PRACTICES

6. Develop a Good Contract – cont’d.

– Non-Competition Provisions

• Know the provisions of the 劳动合同法 – Labor Contract Law

• Use side agreements with key personnel

• Draft the scope of the restrictions with precision

• Draft the liquidated damages provisions carefully

Page 203: From Research to Revenue IV: Capturing Business Opportunities in Asia

203203

最佳做法 – BEST PRACTICES

6. Develop a Good Contract – cont’d.

• Technicalities:– Contract should be in Chinese, or at a minimum, bilingual

– Identify the Chinese party in Chinese characters, as copied from its certificate of incorporation;

– translations vary tremendously and Chinese companies often use short forms of their names in Chinese

Page 204: From Research to Revenue IV: Capturing Business Opportunities in Asia

204204

最佳做法 – BEST PRACTICES

6. Develop a Good Contract – cont’d.

• Technicalities:

• Specify exact terms of payment and performance

• Ensure that that each page is signed and that the contract is properly signed and sealed. Are two signatures required?

• Make provision for inspections and audits, possibly including for the components or inputs, and use them

Page 205: From Research to Revenue IV: Capturing Business Opportunities in Asia

205205

最佳做法 – BEST PRACTICES

6. Develop a Good Contract – cont’d.

Law, Forum and Venue:

– Generally China does not enforce foreign judgments, U.S. judgments in particular

– Specify a choice of law that matches your exit strategy

– If you are based outside of China, consider using arbitration, China is a party to the New York Convention on Arbitral Awards

Page 206: From Research to Revenue IV: Capturing Business Opportunities in Asia

206206

最佳做法 – BEST PRACTICES

6. Develop a Good Contract – cont’d.

Law, Forum and Venue:

• Be careful in choice of arbitrator and arbitration rules, CIETAC has had serious problems recently

• Consider negotiating for the right of discovery - alternatively make plans to collect and retain written records

• Alternatively chose a foreign law, such as Hong Kong, but accept a Chinese court. Chinese courts will try to enforce foreign laws when the parties specify in the contract

Page 207: From Research to Revenue IV: Capturing Business Opportunities in Asia

207207

最佳做法 – BEST PRACTICES

6. Develop a Good Contract – cont’d.

Law, Forum and Venue:

• Specify a choice of venue, the Chinese party is unlikely to agree to come to North America, in part because of cost considerations, consider Singapore law and venue, or Hong Kong SAR

• There is now an agreement between Hong Kong SAR and Beijing on the reciprocal enforcement of judgments

• If possible chose a Chinese venue in which you have other investments

Page 208: From Research to Revenue IV: Capturing Business Opportunities in Asia

208208208

最佳做法 – BEST PRACTICES

7. Monitor your IP after Closing

– Inside and outside of China – some are now shipping labels and product separately for assembly in other countries.

– Register trademarks with General Administration of Customs. They can act ex officio in seizing suspected counterfeit goods.

– Visit trade shows, eBay, small commodities markets in key areas of China, wholesalers, key retailers, places where legitimate products are made and sold

Page 209: From Research to Revenue IV: Capturing Business Opportunities in Asia

209209209

最佳做法 – BEST PRACTICES

7. Monitor your IP after Closing

• Don’t forget internal monitoring

– Implement plant security measures

– Ensure that new employees are trained on security and confidentiality in Chinese

– In supplier’s plants have a representative on site

Page 210: From Research to Revenue IV: Capturing Business Opportunities in Asia

210210210

最佳做法 – BEST PRACTICES

7. Monitor your IP after Closing

• Don’t forget internal monitoring

- Use surveillance equipment or firewalls on web sites

- Ensure that proper security protocols are in place for trade secrets

- Conduct regular training on security measures

Page 211: From Research to Revenue IV: Capturing Business Opportunities in Asia

211211

最佳做法 – BEST PRACTICES

8. Develop your 关系 (guanxi) or relationships– Customs officials– Provincial and city authorities– Embassy – Chinese and foreign based trade associations– Local Administration for Industry and

Commerce 工商行政管理局

Page 212: From Research to Revenue IV: Capturing Business Opportunities in Asia

212212212

INTELLECTUAL PROPERTY PROTECTION IN CHINA:

Best Practices

知识产权的保护在中国 :最佳做法

Paul JonesJones & Co. 钟保禄律师事务所 Джоунс и Ко.

www.jonesco-law.ca

Research to RevenueThe Biotechnology Initiative

December 3, 2008

Page 213: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia

Page 214: From Research to Revenue IV: Capturing Business Opportunities in Asia

THANKS TO OUR SUPPORTERS

Page 215: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:Networking ReceptionFrom Research to Revenue IV:Networking Reception

Page 216: From Research to Revenue IV: Capturing Business Opportunities in Asia

From Research to Revenue IV:From Research to Revenue IV:Capturing Business Opportunities in AsiaCapturing Business Opportunities in Asia