Biotechnology in Europe and Elsewhere – an Overview

crunchkingofprussiaBiotechnology

Dec 6, 2012 (4 years and 8 months ago)

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Biotechnology in Europe and
Elsewhere


an Overview

Simon Smith

Partner, Blake Lapthorn Linnell

16 May 2006

European Biotechnology


Employed approximately 73,600

people (82,400
including Switzerland)


Had 420 new drugs in clinical development or
awaiting approval


Generated

16.3 billion of revenue


Raised

1.3 billion of equity

investment in 2003


Formed 100 new companies

European Biotechnology


As in previous years, the UK was the

single
biggest contributor to this picture. In 2003 the UK
sector:


Comprised 455 companies


Employed approximately 22,400

people


Had 224 new drugs in clinical development or
awaiting approval


half the European total

European Biotechnology


The industry in the UK:


Generated £3.6billion of revenue
-

a 19%
increase over the 2001
-
2002 period


Raised £392 million of equity investment


Formed 36 new companies



Korean Biotechnology


Grew from $1.4 billion in 2002 to $1.95
billion in 2004, an average YoY increase of
22.5%


The medical sector accounts for about 60%
of Korea’s biotechnology industry


Approximately 600 companies


Employ approximately 12,138 people, 54.4%
of who are in R&D, and 45.6% in production







Australian Biotechnology


Approximately 370 biotechnology companies
and 600 medical device companies


54 biotechnology firms listed on the ASX


Approximately 6000 people employed


Market capitalisation of Australian
biotechnology firms listed on the Australian
Stock Exchange (ASX) is A$7.132 billion
(US$5.439 billion)









Indian Biotechnology


265 firms registered in India, over 75% of
which were incorporated in the last five years


The top five companies were homegrown;
Indian firms account for 62% of the
biopharma sector and 52% of the industry as
a whole


Aiming to grow the industry to $5 billion in
revenues generated by 1 million employees
by 2009



Early stage pharma and biotech alliances

Pharma

Biotech



Innovative drugs



New technologies




Capital resources



Clinical development



Regulatory assistance



Manufacturing



Sales & Marketing

Early stage pharma and biotech alliances

Pharma

Biotech



Innovative drugs



New technologies




Capital resources



Clinical development



Regulatory assistance



Manufacturing



Sales & Marketing

Combining pharma
-
biotech expertise

Pharma



Access to technology



Access to products

Biotech/Drug Delivery Company



Discovery/development resources



Commercialisation resources

Combined innovation/value



Validation of scientific approach



Leverage time to market



Ability to bring projects forward that could not exist without partnership



Creation of new IP/technology/products

Challenges and Opportunities

Challenges


Declining success rates
in new drug development


Rising cost of drug
development and
commercialisation


Increasing pressure on
return


Increasing price
sensitivity and growing
reimbursement pressures


Greater regulatory
scrutiny

Opportunities


Rising disease incidence
globally


High unmet, medical needs
eg Alzheimer’s, oncology
etc..


New technologies for
research and development


Expanding success, income
and insurance coverage in
key emerging pharma
markets


Greater patient engagement
in health care decisions

The Market for Early Stage
Research Deals

0
200
400
600
800
1000
1200
No. of Drugs
Preclinical

Phase I

Phase II

Pre
-
registration

Launched

Recent Novartis early stage deals

Licence

Headline value

Rights acquired

Arakis & Vectura

April 2005

$15m each upfront. Up to $172.5m
each in milestones plus royalties

AD237 which is in Phase II trials as
a potential chronic obstructive
pulmonary disease treatment

Avanir Pharmaceuticals

April 2005

$2.5m upfront and eligibility for up
to $2.5, research funding per year
for 4 years plus milestones and
royalties with total value of up to
$200m

Develop orally active small
molecule therapeutics targeting
macrophage migration inhibitory
factor to treat inflammatory
diseases

Hybridon (now called Idera
Pharmaceuticals)

May 2005

$4m licence fee upfront and up to
$132m based upon achievement of
milestones, plus royalties

Develop and commercialise
immunomodulatory
oligonucleotides that are toll
-
like
receptor 9 agonists

Recent Novartis early stage deals


Licence

Headline value

Rights acquired

Anadys Pharmaceuticals

June 2005


$20m upfront. Up to $550m in
milestones

Agreement covers development,
manufacture and commercialisation
of ANA975 and additional TLR7
oral drugs

Arrow Therapeutics

June 2005

$25m upfront. Up to $232m, in
milestones

Development and commercial sale
of A6044 which is a small molecule
oral benzodiazepine in Phase II
trials for the treatment of
respiratory syncytial virus infection

Astex Therapeutics

December 2005

Upfront and deferred equity
payments of $25m with up to
$520m in fees and equity
payments, option payments and
milestones

Focuses on 2 experimental
onocology drugs of the cell cycle
inhibitor family, one in pre
-
clinical
and one in Phase I development

But Bear in Mind Collaboration Can
Be a Stepping Stone…

Acquiror

Target

Headline value

Deal

Novartis

Alnylam

Pharmaceuticals

Initial payments of
approx $56.8m

Develop RNAi therapeutics for pandemic
influenza. Collective payments could be
over $700m, not including royalties

Pfizer

Vicuron

$1.9bn

Gain access to pipeline of anti
-
infectives
for both hospital
-
based and community
-
acquired infections

GSK

Covixa

$300m

Partner for vaccine adjuvants and the
development of the oncology product
Bezzar for the treatment of non
-
Hodgkin’s
lymphoma

AstraZeneca

CAT

£75m for 20% stake

5 year discovery initiation phase for a
minimum of 25 discovery programmes

Merck licensing strategy results in high
value alliances

Licensed products or
patents

44% of total sales

2005 Revenues : $22 billion



In addition, through the partnership with Schering
-
Plough, Merck


shares in the profits of ZETIA and VYTORIN sales: $2.4 billion in 2005



Over $9.5 billion, or 44% of Merck’s sales, are


attributed to alliance products and patents

Key products:



Fosamx



Cozaar/Hyzaar



Nexium



Varivax



Recombivax HB

Partnerships
-

of increasing importance to
Merck

# of alliances formed
10
22
23
38
47
50
44
0
10
20
30
40
50
60
1999
2000
2001
2002
2003
2004
2005
Questions?

simon.smith@bllaw.co.uk