Sector Report Biotechnology & Pharmaceuticals ... - BioPartner.co.uk

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www.uktradeinvest.gov.uk

Sector Report

Biotechnology & Pharmaceuticals
Canada

Produced by:
Gilda Carbone, Trade Officer
UK Trade & Investment/The British Consulate-General
Toronto, Ontario, Canada

Last revised: August 2009

NB: Latest available figures shown. For ease, a current exchange rate of approximately £1 =
CAD$1.80 can be used for conversion purposes.


Whereas every effort has been made to ensure that the information given in this document is accurate, neither UK
Trade & Investment nor its parent Departments (the Department for Business, Innovation and Skills, and the Foreign &
Commonwealth Office), accept liability for any errors, omissions or misleading statements, and no warranty is given or
responsibility accepted as to the standing of any individual, firm, company or other organisation mentioned.
Published August 2009 by UK Trade & Investment. Crown Copyright ©
Biotechnology - Canada
www.uktradeinvest.gov.uk Page 2 of 2


Table of Contents

OVERVIEW 3

OPPORTUNITIES 3

CHARACTERISTICS OF MARKET 4

KEY METHODS OF DOING BUSINESS 7

MORE DETAILED SECTOR REPORTS 7

PUBLICATIONS 8

EVENTS 8

CONTACT LISTS 8

Biotechnology - Canada
www.uktradeinvest.gov.uk Page 3 of 3

OVERVIEW

Industry composition:
Canada maintains over 500 core
1
biotechnology firms, which employ over
13,000 people, generate over CAD$4.2 billion in annual revenue and spend over CAD$1.7 billion
in annual R&D
2
. Over 70% of these firms are located in the provinces of British Columbia,
Ontario and Quebec, and account for about 90% of the revenue generated in the sector
3
. In
2007, the Canadian bio-based economy was estimated to be worth CAD$78.3 billion or 6.4% of
GDP, and comprised of health, medical, and pharmaceutical 63%, agriculture and crops 14%,
organic chemical manufacturing 10%, and food and beverage bioprocesses 13%
4
.

Canadian biotechnology companies include human health 57%, agriculture and food processing
24%, and the remainder in environment, bioinformatics, aquaculture and natural resources
5
.
Factors contributing to growth include a strong research base, financial support, regulatory
framework, human resources, national and regional organisations, and public acceptance of
products. The majority of Canadian biotechnology firms are SMEs with fewer than 50
employees.

Financing:
Financing is one of the major challenges for the industry, which has become more of
an issue during the recent economic downturn. A survey in July 2009 indicated 70% of
biotechnology forms will run out of funds within the next 12 months, up 50% from December
2008
6
. As risk averse investors shy away from investing in biotechs, this has already resulting
in programme cuts and job loses in the industry. The federal government has stepped to
support funding through its venture capital initiatives offered to SMEs through the Business
Development Bank of Canada (BDC). The industry is pressing for further assistance through a
proposed government loan programme.


Public R&D support:
Federal and provincial/territorial governments provide support in the form
of grants, funding, and investments, in addition to R&D and commercialisation tax credits, and
a supportive regulatory framework. The National Research Council (NRC), among other
publically funded R&D organisations, through 20 NRC centres across the country work to
stimulate innovation within a variety of industry sectors, with a view to creating spin-off
companies who licence and commercialise the technology developed through the NRC.

OPPORTUNITIES

A concerted effort by academia, industry, government, associations and the financial
community has helped Canada become a world leader in biotechnology. Canadian companies
and research organisations are attractive international business partners as the country is well-
placed to provide access to other NAFTA markets. A sample of opportunities is outlined below.

R&D and Technology Transfer:
Canadian firms have strong linkages with leading research and
academic institutions and access to public funding opportunities for research conducted in
Canada. Partnerships between UK and Canadian firms and academic institutions can be used to
leverage these opportunities.



1
Primarily in commercialisation of bioscience R&D and development of bioscience-based products/services.
2

Canadian Biotechnology Industry Overview
, Industry Canada, www.ic.gc.ca/eic/site/lsi-isv.nsf/eng/li00275.html ,
accessed August 2009
3
Invest in Canada 2007/2008 edition, Invest in Canada
www.investincanada.gc.ca

4

Measuring the biobased economy: A Canadian perspective, Industrial Biotechnology
, Willian Pellerin and D. Wayne
Taylor, Winter 2008
5
Canada biotechnology profile at BIO 2008 Convention
6

Canadian Govt Reviewing Load Program Request for Biotechs
, Andy Georgiades, Dow Jones Newswires, 16 July 2009
Biotechnology - Canada
www.uktradeinvest.gov.uk Page 4 of 4


Commercialisation:
Opportunities for UK professional services companies that offers consultancy
in commercialisation of R&D, proprietary consultancy, technology licensing, technology transfer,
joint ventures and project financing to bridge the gap between the critical areas of academia,
research and commerce.

Production and trials:
International production and marketing partners, as well as clinical
research organisations that are able to design and undertake clinical trials in the UK for
Canadian pharmaceutical firms.
Non-health:
Opportunities in non-health biotech also exist predominantly in agri-bio applications
such as food (phytochemicals/nutraceuticals) and crop sciences, marine, environmental bio-
applications and renewable energy.
Mergers & Acquisitions:
M&A activity in this sector remains active in order to consolidate and
strengthen the industry. Several UK biopharma companies have entered into strategic alliances
with traditional Canadian drug manufacturers, both in the brand-name and generic sub-sectors.
Examples include partnerships between Pasteur Merieux (now Sanofi Pasteur) and Connaught;
Astra Pharmaceutical and Allelix Biopharmaceutical (now Allelix NPS); Glaxo and BioChem
Pharma, now merged with UK’s Shire Pharmaceuticals and Vancouver-based ID Biomedical.

UKTI publishes international
business opportunities
gathered by our network of British
Embassies, High Commissions and Consulates worldwide. These opportunities appear in the
Opportunities portal on the relevant sector and country pages on the UKTI website. By setting
up a profile you can be alerted by email when relevant new opportunities are published. New or
updated alert profiles can be set in My Account on the website.

CHARACTERISTICS OF MARKET

OPERATIONS
The operations of core Canadian biotechnology firms include
7
:
AgroBio (including food and nutraceuticals) 88
Industrial and Environmental 115
Therapeutics 166
Other biopharma 22
Bioinformatics, Analytical, Genomics and Proteomics 105
Other research and manufacturing services 60
Total 556

Biotechnology product development pipeline (health and therapeutic) in Canada by phase
8
:
Discovery & Preclinical 142
Phase I 77
Phase II 72
Phase III 34
Total 324

Industry Clusters
9

Ontario:
Ontario hosts 32% of Canadian biotech firms
10
. There are over 140 private biotech
firms in Ontario, which employ over 5000 people, and generates over CAD$2.8 billion in annual


7
Canadian Lifesciences Database,
www.canadianlifesciences.com
, February 2009
8
Canadian Lifesciences Database,
www.canadianlifesciences.com
, January 2009
9
Invest in Canada
www.investincanada.org

Biotechnology - Canada
www.uktradeinvest.gov.uk Page 5 of 5

revenues. Strengths include bioinformatics, genomics, biomaterials, biomedical engineering,
stem cells and regenerative medicines, drug discovery, medical devices, agricultural
biotechnology, bioproducts, functional foods and nutraceuticals. It hosts the Canadian
headquarters for AstraZeneca, GSK, Eli Lily, and Pfizer
11
.

The province has more than 60 renowned research centres and 10,000 researchers, including
the MaRS Discovery District. Established in 2000, MaRS fosters commercialisation from
scientific innovation. MaRS is a partnership between universities, hospital researchers, business
and finance. It is also home to the Ontario Genomics Institute.

British Columbia:
British Columbia hosts 18% of Canadian biotech firms
12
. There are over 90
biotech firms in British Columbia, employing 2,200 employees and generating approximately
$779 million in annual revenues
13
. Support infrastructure includes the University of British
Columbia, the BC Cancer Agency, and the Centre for Molecular Medicine and Therapeutics.

Quebec:
Quebec hosts 23% of Canadian biotech firms
14
. Industry strengths include genomics
and biopharmaceuticals with institutions such as the McGill University, Genome Québec
Innovation Centre project, the Biotechnology Research Institute, the Centre Robert-Cedergren
at Université de Montréal, and the Québec Proteomics Centre, supporting these areas. Four
Québec universities (Université de Montréal, Université Laval, McGill University and Université
de Sherbrooke) are recognised in biopharmaceuticals and medicine.

The province recently established a public-private consortium in order to pursue drug
development in Quebec. The Consortium for Drug Discovery includes support by the federal
and Quebec government, Pfizer Canada, AstraZeneca Canada and Merck Frosst Canada. The
Quebec government is pledging CAD$4 million to create the consortium, with Pfizer and
AstraZeneca pledging CAD$5 million over four years, and Merck Frosst CAD$1 million to the first
year of operation
15
.

Other clusters:
Canada’s vast and differing geography has also influenced the biotech industry.
Agri-bio clusters are located in the Prairie Provinces (Alberta, Saskatchewan, Manitoba), while
aquaculture and marine sciences clusters are located in Atlantic Canada and the Pacific coast of
British Columbia.
Research and Development
Canada has recognised that strong scientific expertise and continuous investment in R&D are
key factors to growth in the industry. Governments at all levels have made concerted efforts to
invest in a supportive infrastructure for the industry. There are 17 medical schools in Canada
and 16 Canadian universities are affiliated with a network of over 100 teaching hospitals and
research institutes. In addition, a series of funding programmes and tax credits offer support for
the industry. Some examples are noted below.
In 1983, the federal government developed a national biotechnology strategy and established
the National Research Council’s biotechnology programme. The strategy set out to stimulate
the development of a critical mass of research infrastructure, large pools of post-graduate and
post-doctoral research, world-class academic, public and private sector research investigators,
entrepreneurs and a biotech sector vision.


10
BiotechCanada,
www.biotech.ca
, accessed August 2009
11

Life Sciences in Ontario,
Invest in Ontario


www.investinontario.com/lifesciences/default.asp
, accessed August 2009
12
BiotechCanada,
www.biotech.ca
, accessed August 2009
13

Invest in Canada 2009: Biopharmaceuticals,
Industry Canada
http://strategis.ic.gc.ca

14
BiotechCanada, www.biotech.ca, accessed August 2009
15

Drug development boosted in Quebec
, The Gazette (Montreal), 18 June 2008
Biotechnology - Canada
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Established in 1992, The Networks of Centres of Excellence (NCE)
16
programme links academic
and industry researchers. Since 1994, the nine biotechnology NCEs have spun-out 40 new
companies to commercialise technologies. The federal government provides CAD$77.4 million
of funding each year
17
.

The Scientific Research and Experimental Development (SR&ED) programme is a federal
initiative offered to Canadian controlled firms pursing scientific research. Firms can apply to
tax credits against wages, materials, machinery, equipment, some overhead, and SR&ED
contracts. These firms can claim a tax credit of 35% up to the first CAD$2 million of qualifying
expenditure, and 20% of any excess. Research must be undertaken in Canada
18
.

Regulation
Canada’s product-based regulatory system for biotechnology uses a modern risk management
approach and up-to-date scientific experience. The federal government uses existing legislation
and institutions to regulate products. Canada is considered a global leader; its regulatory
system is used as a model for new systems in other countries.

Canada’s drug approval system has become internationally competitive by halving approval time
since 1994. Canada, with an average drug approval time of 545 days, is beginning to rival
other G7 countries such as the United States and France. Intellectual property protection for
new drugs also meets international standards.
The pricing and reimbursement system is comprised of
19
:

Patented Medicine Prices Review Board (PMPRB) – Oversees the price charged by the
manufacturer of patented pharmaceuticals

Common Drug Review – Recommendation of coverage by federal, provincial/territorial
public drug plans.

Public Drug Plans: Final price is set and terms of reimbursement.

Health Canada is the federal government agency responsible for the regulation of biotechnology
including foods, drugs, cosmetics, medical devices and pest control products in Canada. Key
Health Canada
20
directorates and databases include:

Therapeutic Products Directorate is responsible for pharmaceutical approvals. Prior to
approval, the manufacturer must demonstrate the product’s safety, efficacy and quality, as
outlined in the Food and Drugs Act and Regulations. The Special Access Program (SAP)
allows patients access to pharmaceuticals prior to Health Canada approval if requested by a
physician.

Biologics and Genetic Therapies Directorate is responsible for
biological/radiopharmaceuticals drugs, blood and blood products, viral and bacterial
vaccines, genetic therapeutic products, tissues, organs and xenografts.

The Canadian Food Inspection Agency (CFIA), along with Health Canada, is responsible for
regulating agricultural biotechnology. This includes assessing the safety of plants, animal
feeds and animal feed ingredients, fertilizers and veterinary biologics. The Canadian Food
Inspection Agency enforces the regulations through its Directorates; the Food Directorate
for functional foods, and the Natural Health Products Directorate for nutraceuticals and
other natural health products
21
.


16
Networks of Centres of Excellence
www.nce.gc.ca

17

Invest in Canadian Life Science – R&D Infrastructure and Government Resources
, Industry Canada, accessed August
2009
18

Invest in Canadian Life Science – R&D Infrastructure and Government Resources
, Industry Canada, accessed August
2009
19
Biotech Canada Insights Spring 2008
20
BioRegulations
www.bioregulations.gc.ca

21
Health Canada
www.hc-sc.gc.ca

Canadian Food Inspection
www.inspection.gc.ca

Biotechnology - Canada
www.uktradeinvest.gov.uk Page 7 of 7


Patent Register lists medicines and associated patents, patent expiry dates and other
related information. It can be accessed at
http://205.193.93.51/patent/english/index.cfm
.

Drug Product Database lists product specific information on drugs approved for use in
Canada, including human pharmaceutical and biological drugs, veterinary drugs and
disinfectant products. It can be accessed at
www.hc-sc.gc.ca/dhp-
mps/prodpharma/databasdon/index-eng.php


In-market regulatory consultants can assist UK companies with guidance through the regulatory
and approval system.

KEY METHODS OF DOING BUSINESS

Industry events:
Industry events provide an ideal opportunity to establish collaborative
relationships for R&D, joint ventures, technology transfer, etc. The three main Canadian
biotechnology events (noted in the events section of this report) offer online meeting
arrangements for one-to-one meetings during the events. Canadian delegations are often
organised to participate in key industry events outside of Canada, for example BIO in the US,
which presents another opportunity for UK players to establish relationships with Canadian firms
and academia.
In-market representation:
Appointment of an agent or distributor. The Canadian market can
normally be penetrated through the appointment of one or two representatives, which typically
cover either the North American, national, or regional (eastern/western Canada or
provincial/territorial) market.
Mergers, Acquisitions & Strategic Alliances:
Mergers, acquisitions and strategic alliances remain
a significant option as consolidation relieves the capital shortage faced by many smaller biotech
companies. This helps restock the pipeline as other drugs come off patent. Canadian firms
consider M&A a tool to take products to full development. Alliance activities in the form of
licensing, manufacturing, research and marketing collaborations frequently occur with
Canadian, US and international firms and academic institutions.

Other background information on doing business in Canada can be found on UKTI’s website.
Simply go to the Canada country page where you will find information on:

• Economic background and geography
• Customs & regulations
• Selling & communications
• Contacts & setting up
• Visiting and social hints and tips

MORE DETAILED SECTOR REPORTS
Research is critical when considering new markets. UKTI provides
market research
services
which can help UK companies doing business overseas including:

• Overseas Market Introduction Service (OMIS). Bespoke research into potential
markets, and support during your visits overseas



Food Directorate
www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/fd-da/index_e.html

Natural Health Products Directorate
www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index_e.html

Biotechnology - Canada
www.uktradeinvest.gov.uk Page 8 of 8

• Export Marketing Research Scheme. In-depth and subsidised service administered
by the British chambers of Commerce on behalf of UKTI

Contact your local
International Trade Advisor
if you are interested in accessing these services
or for general advice in developing your export strategy.

PUBLICATIONS

Bio Business
www.biobusinessmag.com


Biotechnology Focus
www.bioscienceworld.ca


EVENTS

BioContact
www.biocontact.qc.ca


BioFinance
www.biofinance.ca


BioPartnering North America
www.techvision.com/bpn/


BIO International Convention
www.bio.org
(Location differs throughout North America each
year. A significant Canadian presence participates in this key industry event.)

UK Trade & Investment’s
Tradeshow Access Programme
(TAP) can help eligible UK businesses
take part in overseas exhibitions. Attendance at TAP events offers significant benefits:

• possibilities for business opportunities both at the show and in the future
• a chance to assess new markets and develop useful contacts
• grants are available if you meet the criteria
• UKTI staff overseas will be available to assist delegates

Find out if you are eligible to apply to attend this event, and more about the support UKTI can
offer, on the UKTI
Market Entry
web page.

Details of TAP events can be found in the Events portlet on the Canada page.

Other Market Visit Support may be available via your local International Trade Advisor.

CONTACT LISTS

BioQuébec
www.bioquebec.com


LifeSciences British Columbia
www.lifesciencesbc.ca


BioAlberta
www.bioalberta.com


Ag-West Bio Inc.
www.agwest.sk.ca


BioAtlantech
www.bioatlantech.nb.ca


Biotechnology - Canada
www.uktradeinvest.gov.uk Page 9 of 9

The Biotechnology Initiative
www.torontobiotech.org


Ottawa Centre for Research and Innovation (OCRI)
www.ocri.ca


UKTI’s International Trade Advisers can provide you with essential and impartial advice on
all aspects of international trade. Every UK region also has dedicated sector specialists who can
provide advice tailored to your industry. You can trace your nearest advisor by entering your
postcode into the
Local Office Database
on the homepage of our website.

For new and inexperienced exporters, our
Passport to Export
process will take you through the
mechanics of exporting. An International Trade Adviser will provide professional advice on a
range of services, including financial subsidies, export documentation, contacts in overseas
markets, overseas visits, translating marketing material, e-commerce, subsidised export training
and market research.
UKTI representative with responsibility for the Biotechnology and Pharmaceuticals sectors in
Canada:
Gilda Carbone, Trade Officer
UK Trade & Investment/British Consulate-General
Toronto, Ontario, Canada
T: 001 416 593 1290 ext 1+2224
E:
Gilda.Carbone@fco.gov.uk