Asia Healthcare & Biotech - Cambridge Healthcare & Biotech

jamaicanabsorbingΒιοτεχνολογία

5 Δεκ 2012 (πριν από 4 χρόνια και 8 μήνες)

399 εμφανίσεις

Asia

Healthcare &
Biotech

A

&

H

B

Asia Healthcare & Biotech

“BRIC
-
ing” it


these slides can be downloaded at

http://mbe.chandb.com

0000
-
0000
-
x00
-
2

Business 101:

Every commercially successful life sciences company needs
three things

Product ideas

Funding to
develop product

Customers to
buy product


Innovation is closely linked to the quality of
R&D


USA, UK, Japan, France & Germany lead
the world


..but in the future?

Could come from
anywhere


Risk financing has become more difficult to
obtain from traditional sources (eg, VCs)


Emerging market entrepreneurs,
governments and oligarchs are beginning
to embrace funding high risk/high return
projects

Could come from
anywhere


Cost containment measures in established
markets are forcing established
companies into emerging high growth
markets to maintain profitability

Wherever there
are lots of
customers who
can afford to buy

0000
-
0000
-
x00
-
3

Why BRIC it?


Chasing growth in a slowing global market


Important thing these markets have in common are:


Vast populations


Growth of the middle classes


A rapid increase in the number of high net worth individuals and organisations


A desire of the middle classes to spend more and improve overall education and
health


A lax attitude to intellectual property protection, although this is changing


mainly
driven by the desire to attract foreign investment and a desire to globalise the fruits of
local innovation and production


But in each country the gap between the middle classes and the poor in terms of access to
healthcare and education is vast


Brazil, Russia, India & China are very different markets
-

a homogeneous BRIC strategy will
not be optimum


We prefer the term “Emerging Markets” (EM) to BRIC

0000
-
0000
-
x00
-
4

Brazil as an example


Brazil has a rapidly growing middle
class as it's GDP is now 6th largest
globally


Brazilian health system growing at
35% cagr, compared with 4% globally


The Brazilian government has offered
75,000 scholarships to Brazilian
students who want to study science
overseas!


0000
-
0000
-
x00
-
5

… but is trade between developed markets and
emerging markets be stifled by “well
-
meaning”
politicians?


“UK is fully committed to Europe. We wish the Eurozone well. The UK is still the number 1 gateway to Europe”, Vince
Cable, Dec 2011 at a lunch for the Chinese Ambassador


“There is absolutely no country more important to Britain than China”, Lord Green, Dec 2011


BUT

“The UK is [only] the 3rd largest trading partner in EU for China”, Gao Hucheng, same lunch


“We hope EU will lift ban on high
-
tech exports to China. We want level playing field, so we can share opportunities” Gao
Hucheng


“UK exports to China up 20% in 2011, up 40% in 2010, but still small % of China's imports”, Vince Cable


“In China 60% of economy is from SMEs”, Gao Hucheng


“We would like to move from trade, through joint investment, to joint R&D between SMEs in our countries”, Gao Hucheng


“$5bn equity investment by Chinese companies into UK companies this year”, Ambassador Liu Xiaoming


China planning to spend $300bn on biotechnology in next 5 years


BUT
,
“Investors in Hong Kong have too many short term opportunities to be interested in long term biotech" CEO, HK
Science & Technology Parks Co, Sep 2011


“China is home to more than 400 BioSimilar manufacturers”, Alex Kudrin, Takeda, Feb 2012


Overheard comment from a major US pharma company, “For us it's Dubai, Mumbai, Shanghai or bye
-
bye"


Relative growth in overseas markets has affected us as well.
In its first 5 years over 30% of CH&B's revenue came from the
UK. In the last 5 yrs it was less than 10%, in the last 3 it was less than 5%. This year it’s less than 2%

0000
-
0000
-
x00
-
6

Many major western companies are looking at EMs as opportunities for
their products, but will we see EMs as sources of products for Western
markets soon?


The academic output of universities is measured on an annual basis by the
Institute of Higher Education, Shanghai Jiao Tong University


The highest ranking university in the world on this basis is Harvard in the USA.
This university is given a score of 100 and all other universities are scored
according to Harvard’s output


We have correlated the combined “academic scores” for all universities in a
particular country against the number of biopharma products in active development
by all companies with that particular country as its head office and have found that
the correlation is almost one to one.


Hence for a country in which all universities have the same combined academic
output as Harvard alone, we would expect that the combined number of biopharma
products in active development by all companies that have that country as its HQ
would be approximately 100

0000
-
0000
-
x00
-
7

Academic output v products in development

Asia and Australasia (excluding Japan)

Source:
CH&B analysis of data from Pharmaprojects and the Institute of Higher Education, Shanghai Jiao Tong University, 2008


Australia

S.Korea

India

China

Taiwan

Singapore

N.Zealand

Hong Kong

0

50

100

150

200

250

0

50

100

150

200

250

300

academic output of all universities in the country

number of pharma products in development

HARVARD

0000
-
0000
-
x00
-
8

Patent Applications & Grants in India
2001-2007
0
10000
20000
30000
40000
2001
2002
2003
2004
2005
2006
2007
Year
Number
Applications
Grants
Trade Mark Applications & Grants in India
2003-2007
0
50000
100000
150000
200000
2003
2004
2005
2006
2007
Year
Number
Applications
Grants
Source: Managing IP, April 2008

IP development activity in India is
growing rapidly due to the changing IP
landscape and the influence of MNCs
like IBM, Microsoft and others.

Availability of talent pool, top academic
institutions, R&D facilities and world
-
class companies can only accelerate
this trend.

IP in India


a growth story

0000
-
0000
-
x00
-
9

Trend of academic output in India (a country with a much
lower academic output than China)


Looking at the 2 top Indian Universities (measured by academic output)


Indian Institute Of Science, Bangalore


Indian Institute of Technology, Kharagpur

18.2

18.4

18.6

18.8

19

19.2

19.4

19.6

2005

2006

2007

Academic output
of the top 2
Indian
Universities as a
percentage of
Harvard

+4.4%

0000
-
0000
-
x00
-
10

Using BioSimilars as a case study


$100 billion worth biologics are expected
to go off patent by 2020


30 biologics with annual sales of $51
billion losing patent protection before 2015

sources:

Anna Harrington
-
Morozova, REGEM Consulting

Global Biosimilars Market (Million US$), 2010 & 2015, IMS Health

0000
-
0000
-
x00
-
11

BioSimilars authorised in the EU

Product

INN

Company

Reference
Product

Year of
Approval

Omnitrope

Somatropin

Sandoz Int Ltd

Genotropin

2006

Valtropin

Somatropin

Biopartners GmbH

Humatrope

2006

Vinocrit

Epoetin Alfa

Sandoz Int Ltd

Eprex

2007

Epoetin Alfa Hexal

Epoetin Alfa

Hexal AG

Eprex

2007

Apseamed

Epoetin Alfa

Medise Arzneimittel Putter GmbH

Eprex

2007

Retacrit

Epoetin Zeta

Hospira Inc.

Eprex

2007

Silapo

Epoetin Zeta

Stada Arzneimittel GmbH

Eprex

2007

Biograstim

Filgrastim

CT Arzneimittel GmbH

Neupogen

2008

Ratiograstim

Filgrastim

Ratiopharm GmbH

Neupogen

2008

Tevagrastim

Filgrastim

Teva Generics GmbH

Neupogen

2008

Zarzio

Filgrastim

Sandoz Int Ltd

Neupogen

2009

Filgrastim Hexal

Filgrastim

Hexal AG

Neupogen

2009

Nivestim

Filgrastim

Hospira Inc

Neupogen

2010

source: Anna Harrington
-
Morozova, REGEM Consulting

0000
-
0000
-
x00
-
12

BioSimilars in Emerging Markets

source: Anna Harrington
-
Morozova, REGEM Consulting

Country

Company

Marketed products and
known pipeline

India


Dr Reddy’s Labs

Rituximab (2007), filgrastim, Darbepoetin alfa,

Bharat Biotech

RHEGF, streptokinase,
urokinase, staphylokinase


Biocon

insulin, EPO, GCSF, Streptokinase, BioMAb EGFR

Wockhardt

EPO, Insulin, Hepatitis B, GCSF

Intas Biopharma

EPO, Interferon α, GCSF

Reliance Life Sci

EPO, Interferon α, GCSF, FHS

Cipla

Avastin, Enbrel and Herceptin


China


3S Bio

EPO, thrombopoietin, interferon alpha 2a, and interleukin
-
2,
mAbs


Shanghai Celgen

Etanercept (2011)

Taiwan


Mycenax Biotech

Etanercept

S. Korea


LG Life science

Interferon γ, HGH, Hepatitis B vaccine

Dong
-
A Pharm

G
-
CSF,
trastuzumab


Celltrion

Trastuzumab, infliximab, 6 other mAbs


SK Chemicals

Oseltamivir


Hanwha

Enbrel


Argentina


Sidus Group

EPO, Insulin, Interferon α 2a, 2b, GCSF, HGH

Roemmers

EPO, Interleukine, Interferon α 2a, 2b, GCSF, FHS, somatropin

Brazil


PharmaPraxis

adalimumab


Russia


Biocad

Interferon a 2b,
β

1b, GCSF
, Trastuzumab, Rituximab, Bevacizumab, Filgrastim, EPO, FS VII, VIII


SinBio

Rituximab


0000
-
0000
-
x00
-
13

BioSimilar regulations in EMs are following the
EU


Asia


Taiwan, a final guideline 21 November 2008: Review Criteria for Registration and Market Approval of Pharmaceuticals
-
Registration

and
Market Approval of Biological Products. 22 December 2010, guideline: Examination key points of technical information for Bios
imi
lars
registration


Malaysia, final guidance 30 July2008: Guidance Document for Registration of BioSimilars in Malaysia.


Singapore , final guideline August 2009


South Korea, final guideline 2009


India a final guideline 11 July 2008: Preparation of the Quality Information for Drug Submission for New Drug Approval:
Biotechnological/Biological Products.


Latin America


Venezuela, final guideline 3 August 2000, Application for DNA recombinant products, monoclonal and therapeutic antibodies


Brazil, initial guideline 26 October 2005, Technical Rules for Registration of Biological Products. New regulation 17 Dec 20
10


Colombia, draft guideline; License for Manufacturing facilities of biological products.


Argentina, final guideline February 2011: Registration and registry modification of biological medicinal products.


Mexico, draft guideline 9 October 2008: Ley general de medicamentos biotecnológicos.


Guatemala, final guideline Decemeber 2010


Costa Rico, draft regulation 14 January 2011


Chile, draft guideline October 2011


Middle East and CIS


Middle East, the consensus group recommended implementation of EMEA guidelines in the Near and Middle East.


Turkey, final guideline August 2008:Instruction Manual on Biosimilar medical products.


Saudi Arabia, final guidance November 2009 Drug Master File Requirements for the Registration of Biosimilars.


Israel, final guideline March 2009


Kazakhstan, final guideline November 2009


Belarus, final guideline Oct 2010

source: Anna Harrington
-
Morozova, REGEM Consulting

0000
-
0000
-
x00
-
14

China


Chinese Government plans to spend on biotechnology 2 trillion yuan (>US$300 billion) in next five
years.


China has the second world largest human capital in science and technology. 51 national key
laboratories in China are in life sciences


Domestic biosimilars have been on the market for 20 years. The first recombinant human interferon
beta 1b was launched in 1989. Now 40 per cent of China’s recombinant biologic product sales are
biosimilars.


There are over 200 biopharma firms producing over 2,000 drugs. Over 20 producers of interferon and
more than a dozen erythropoietin manufacturers exist


Currently, there is no definition, guidance or pathway for biosimilars in China. A protracted and
complicated drug registration process increases regulatory approval timelines, impacting market access.


Despite many biogenerics being reimbursed, low purchasing power still limits uptake in China

source: Anna Harrington
-
Morozova, REGEM Consulting

0000
-
0000
-
x00
-
15

India


State Biotechnology Industry Partnership Programme., supporting biotech companies on a cost
-
sharing
basis for development of novel and high risk technologies and biosimilars.


Biotechnology parks under construction in Hyderabad, Bangalore, and Pune


Many Indian manufacturers have announced investments in the biosimilar space. Dr Reddy's
Laboratories and Biocon each plan to invest between 1.5 and 5 billion rupees ($US33.4

111.2 million).


Biosimilars being sold 25
-
50 % cheaper than the original biologic.


Regulatory process in some cases allows registration based only on data from phase III study in 100
patients


India is aiming to upgrade its current 1.4% share in the global biopharma market to 10% by 2020

source: Anna Harrington
-
Morozova, REGEM Consulting

0000
-
0000
-
x00
-
16

BioSimilars in Emerging Markets: Advantages, Challenges &
Conclusions


Advantages


Absent or unenforced patent laws in some countries make biosimilars registration possibility as soon as original drug was lau
nch
ed.


In countries where IP protection is reinforced much shorter data exclusivity applies (3
-
5 years vs 10
-
12 in EU/US)


In some cases,biosimilar became available prior to innovator product


Low development and manufacturing cost allows up to 50% price reduction vs. original product.


In India, China, S.Korea, Russia, Brazil and some other countries state funding is provided to local industry


Challenges


Significant number of local competitors creates interchangeability issue in patients’ care.


Pharmacovigilance systems in EM are less developed and does not provide sufficient post
-
marketing support.


GMP is not enforced in all EM countries.


Transparency in publishing results of clinical trial and in decision process at regulatory agencies is not present in all EM



There is the question of whether available clinical data could support accelerating entry of biosimilars from EM to ICH mar
ket
s.


In some EM, like China and Russia, absence of guideline and separate registration pathway negatively affects domestic and
international commercialisation


Conclusions


Biosimilar Industry in EM has advantages of state funding, early market entry and low manufacturing cost. It could soon play
key

role in global biosimilar development and marketing.


Extensive experience with biosimilar is being accumulated by regulatory authorities and industry in EM. Information exchange
and

harmonisation efforts are required in market surveillance, transparency and quality standards .


Advance planning of global clinical development programme could increase value of clinical data used for first registration i
n E
M for
expansion to ICH regions and ensure expedited registrations in EMs for biosimilar developed in EU/US

source: Anna Harrington
-
Morozova, REGEM Consulting

0000
-
0000
-
x00
-
17

Asia Healthcare & Biotech: Taking IP “the other way”


Many of the larger European & US life science companies have already made significant strategic moves to access
the rapidly developing markets of India and China


The increased affluence of Asia has also resulted in an explosion in education and basic research in these countries


Asia Healthcare & Biotech aims to access and exploit commercially attractive Asian IP in the already developed
markets of Europe and the USA


We already have “seekers” in India and Singapore and are rapidly developing our network in Asia


We also have:


An in
-
depth understanding of European and US markets for life scieince products


An established network and relationships with investors in these markets


An establised network and relationships with possible development partners in these markets