Europe Organ Preservation Market PPT: Demand, Trends and Business Opportuniti...
France Pharmaceuticals report June 2016
1. FRANCEJUNE 2016
SPOTLIGHT
ON G5 HEALTH
PAGE 16
ASCENT
OF THE CMOs
PAGE 37
NASCENT BIOTECH
REVOLUTION?
PAGE 40
EMBRACING
DIGITAL DISRUPTION
PAGE 64
LA FRENCH INNOVATION! page 23
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ACKNOWLEDGEMENTS
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Acknowledgements
Pharmaboardroom would like to thank:
Patrick Errard, President LEEM and General Manager Astellas
France
Philippe Lamoureux, General Manager, LEEM
Thomas Fatome, Director, Direction de la Sécurité Sociale
Marc de Garidel, Chairman and spokesperson of the G5,
Chairman and CEO of IPSEN
François Sarkozy, President, FSNB Health & Care
Claude Le Pen, Consultant, IMS Health
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FOREWORD
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The pharmaceutical sector has, for a long time, been considered one of the cornerstone
industries in France and a driver of national competitiveness. The country’s power-
ful and innovation-led R&D ecosystem, bolstered by a well-developed overall public
research infrastructure, strong tradition in start-ups and highly qualified human capi-
tal base well versed in industrial expertise, all combine to render the sector strategically
relevant.
Healthcare and life sciences, indeed, constitute one of the very few sectors of the
national economy with the ability to contribute holistically - via innovation - to the
economic, social and industrial recovery of France, even beyond the benefit delivered
up to patients.
In spite of the sector’s inherent dynamism, prevailing indicators on market access,
balance of trade, job creation and taxation all point towards some concerning trends.
Successive waves of cost-containment policy have only served to cripple France’s indus-
trial performance in life sciences. We have now reached a critical turning point.
Against a backdrop of unprecedented scientific and industrial change, France now
urgently needs to implement a long-term approach dedicated towards reforming its
public healthcare system and sustaining its hard-won reputation for healthcare excel-
lence. Structural reform of the system itself and a transition towards efficiency-based
health provision have become all but essential.
The challenge may look formidable, but the pharmaceutical companies and French
Government alike both appreciate the sector’s trump cards. The shared commitments
of the Strategic Council for Health Industries, reflect a genuine desire to foster the
development of new health ecosystems supporting innovation and advances in patient
care. The industry’s core drivers – innovation, attractiveness and efficiency – have justi-
fiably been placed under the spotlight during our dialogue with the public authorities.
France possesses the requisite assets to properly support such a strategy: exploiting
its competitive strengths at an international level and fostering the attractiveness of
the territory for companies and their investment decisions.
The following report, with its comprehensive study of our local industry, not only
sheds light on the issues essential to France’s future economic development, but also
offers industry stakeholders an excellent opportunity to understand the challenges
and opportunities that our sector is facing right now and in the years to come.
Philippe Lamoureux
General Manager, Leem
6. PREFACE
6 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
Long prized for their creativity,
audacity and pioneering spirit,
the French pharmaceuticals, well-
ness and life sciences communi-
ties today find themselves grap-
pling with many a thorny challenge
increasingly familiar to mature West
European healthcare markets. As
spiraling drug development costs
and mounting patient needs con-
verge to place ever greater stress
on a national healthcare system
lauded for its staunch and unwa-
vering adherence to the twin prin-
ciples of “universality” and “inno-
vation promotion,” it is clear that
“business-as-usual” is no longer
an option. This report charts
France’s progress and uniqueness
in responding to the emergent con-
cepts of ‘sustainability’, ‘market
access’ and ‘patient-centricity’. It
takes stock of how disruptive digital
forces and out-of-the-box method-
ologies in logistics are transforming
the local rules of the game. It lifts
the lid on the evolving strategies
being deployed by the country’s
iconic mid-cap pharma trailblazers.
Most of all, it assesses the efforts of
an entire industry to regain compet-
itiveness and to properly capitalize
upon a well-acknowledge prowess
in medicinal invention..
Preface
France
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The Healhcare & Life Sciences Review was produced
by PharmaBoardroom.
Report Publisher: Diana Viola
Project Director: Crystelle Coury
Editorial Coordinators: Zachary Burnside, Christopher Crachiola
Project Assistants: Karen Xi, Frances Doria
Senior Editor: Louis Haynes
Editor: Patrick Burton
Graphic design: Carmen Reyes, Miriam León
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Copyright: All rights reserved. No part of this publication maybe reproduced in any
form or by any means, whether electronic, mechanical or otherwise including photo-
copying, recording or any information storage or retrieval system without prior written
consent of Focus Reports. While every attempt is made to ensure the accuracy of the
information contained in this report, neither Focus Reports nor the authors accept any
liabilities forerrors and omissions. Opinions expressed in this report are not necessarily
those of the authors.
HEALTHCARE & LIFE SCIENCES
REVIEW FRANCE
CONTENTS
— June 2016
The
Metamorphosis
of French
Healthcare
Interview
12
La French
Innovation
Cover story
23
Embracing Digital
Disruption
Feature
64
3 ACKNOWLEDGEMENTS
5 FOREWORD
6 PREFACE
8 SNAPSHOT IN FIGURES Geo-spacial Mapping
of French Pharma / Leaderboard & Bottlenecks
/ Retail Trends & Exports
11 DRUG PRICES INTERVIEW Dominque Giorgi, CEPS
12 NEW DEVELOPMENTS IN HEALTHCARE
INTERVIEW Claude Le Pen, IMS Health
15 GENERICS Comparative Overview
16 INDUSTRY COORDINATION FEATURE
Mobilising for Change
18 IPSEN’S INTERNATIONAL STRATEGY
INTERVIEW Marc de Garidel, Ipsen
20 HEALTHCARE LOGISTICS FEATURE
Accelerating into the Future
23 LA FRENCH INNOVATION! COVER STORY
25 Winds of change
27 Fair price for innovation?
30 Blossoming of the home-grown champions
30 ATU: red herring or real solution?
33 Switching the paradigm from treatment to prevention
34 At the pioneering frontiers of dermo-cosmetics
35 Maintaining a manufacturing base in the face
of delocalization
36 Local Industry Growth-spots
37 The ascent of the CMOs
39 A more conventional approach
40 Nascent biotech revolution?
42 Diagnostics: the bedrock of an efficient healthcare system
45 ‘La French Tech’: the new entrepreneurial vibe
45 Rediscovering former glories
46 BIOTECH INTERVIEW Judith Greciet, Onxeo
50 MANUFACTURING INTERVIEW Nicolas Bardonnet,
Promega
52 CONTRACT MANUFACTURING INTERVIEW
Aurélien Chaufour, Anjac Health & Beauty
56 CORPORATE SOCIAL RESPONSIBILITY
FEATURE Shifting the Paradigm
58 CLINICAL RESEARCH INTERVIEW Patrick Winkler
& Geoffrey Bilon, Medpace
60 OPTHALMOLOGY RESEARCH INTERVIEW
Yann Quentric, Iris Pharma
64 EMERGING TRENDS FEATURE Digital Disruption
8. 8 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
Source: Leem 2015.
SNAPSHOT IN FIGURES
Geo-spacial Mapping of French Pharma
THE OVERALL PHARMACEUTICAL INDUSTRY CONTRIBUTION IN FRANCE
The 3rd-largest
investor
in private-sector research
in France
821 CLINICAL TRIALS IN
FRANCE, AROUND 70%
OF WHICH ARE INITIATED
BY PHARMACEUTICAL
INDUSTRY
€4.8 billion
invested annually in research
and development (R&D)
10.6% OF SALES
REVENUE INVESTED
IN RESEARCH AND
DEVELOPMENT (R&D)
2nd-largest
exporting
industry
in France
€25 BILLION
IN EXPORTS
50% of health
system savings
BUT ONLY 15% OF
HEALTH-RELATED
EXPENDITURE
€8 billion worth
of drug packs produced
annually in France for
worldwide export
200+
MANUFACTURING
SITES THROUGHOUT
FRANCE
99,000
direct jobs
1 PHARMACEUTICAL
INDUSTRY JOB CREATES
4.5 JOBS ELSEWHERE IN
THE ECONOMY
20,000
PEOPLE EMPLOYED
IN R&D FACILITIES
290,000
DIRECT AND
INDIRECT JOBS
more than 20,000
10,000 to 20,000
5,000 to 10,000
2,000 to 5,000
fewer than 2,000
Île-de-France: 27.8%
Rhône-Alpes: 13.6%
Centre: 9.8%
Haute-Normandie: 8.2%
Aquitaine: 5.2%
Paca: 4.5%
Midi-Pyrénées: 4.1%
Alsace: 4.2%
Nord – Pas-de-Calais: 4.0%
9 REGIONS WITH A HIGH CONCENTRATION OF JOBSWORKFORCE SIZE
3,949
2,3818,160
1,234
370
416
760
4,2041,733
1,611
1,725 9,733
1,771
1,503
2,396
13,506
4,516
2,567
4,085
5,188
27,645
9. Healthcare & Life Sciences Review: France 9www.pharmaboardroom.com
SNAPSHOT IN FIGURES
Leaderboard & Bottlenecks
TOP RANKING FOR YEAR 2015 SALES IN EUROS
BOTTLENECKS IN THE SYSTEM
GROUPS TOTAL RETAIL HOSPITALS
1 NOVARTIS 2,317,068,640 2,090,123,542 226,945,098
2 SANOFI 2,070,474,435 1,535,364,122 535,110,313
3 PFIZER 1,389,508,457 1,010,355,090 379,153,367
4 MERCK & CO 1,355,666,037 821,475,510 534,190,527
5 MYLAN 1,271,497,759 988,830,176 282,667,583
6 ROCHE 1,248,423,662 923,524,488 324,899,174
7 SERVIER 1,220,099,338 1,210,748,051 9,351,287
8 GILEAD SCIENCES 1,020,796,069 625,729,942 395,066,127
9 JANSSEN-CILAG 932,237,601 650,891,675 281,345,926
10 ASTRAZENECA 845,258,978 757,255,285 88,003,693
11 GLAXOSMITHKLINE 820,097,432 715,213,400 104,884,032
12 BAYER 753,613,297 653,308,309 100,304,988
13 BRISTOL-MYERS SQB. 721,660,869 456,271,647 265,389,222
14 TEVA 652,001,967 607,081,469 44,920,498
15 ABBVIE 581,696,690 435,908,795 145,787,895
16 AMGEN 553,976,618 460,255,693 93,720,925
17 FRESENIUS 453,462,841 432,242,939 21,219,902
18 PIERRE FABRE 438,235,294 411,018,433 27,216,861
19 NOVO NORDISK 406,215,278 349,818,875 56,396,403
20 LFB 381,926,748 381,519,228 407,520
Source: IMS.
Source: Leem 2015.
THE 224 PHARMACEUTICAL
AND BIOTECHNOLOGY SITES
across France invested € 810
million in 2013; € 120 million less
than in 2010.
THE AVERAGE TIME TAKEN BY
ANSM (French National Agency
for Medicines Safety) to process
more than 90% of requests to
change the safety information
contained in patient leaflets was
426 days in 2014; four times
longer than the period of 90
days required under the terms of
the relevant regulations.
OF THE 130 NEW MOLECULES
licensed in Europe in 2012-
2014, only 8 will be produced
in France. By comparison,
Germany will produce 32, the
UK 28, and Ireland and Italy 13
each.
MORE THAN TWO-THIRDS
OF SITES in France are not
approved to export to the
United States, despite it being
the world’s largest market for
health products.
DESPITE ITS LEADERSHIP
in the production of vaccines,
France’s performance in the
manufacture of biological
drugs is disappointing: the
country produces only 3% of
the monoclonal antibodies
consumed locally.
THE VALUE ADDED by
pharmaceutical production in
France has fallen by 18 points
since 2000 (from 40% to 22%).
10. 10 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
SNAPSHOT IN FIGURES
Retail Trends & Exports
TREND IN RETAIL PHARMACY DRUG SALES IN THE MAJOR WORLD MARKETS (%)
TREND IN EXPORTS OF MEDICINES (€ MILLION)
BALANCE OF TRADE IN 2014: €+6BN COMPARED WITH €8.8BN IN 2013
Source: Leem 2015.
Source: Leem 2015.
2005 16,747
2006 18,081
2007 19,170
2008 21,164
2009 23,105
2010 24,137
2011 22,030
2012 25,296
2013 26,299
2014 25,028
-5.0%/2013
2012 2013 2014
-2%
2%
4%
-8%
1%
0%
-5%
0%
-1%
-2%-2% -2%
5%
8%
1%1% 1%
3%
13%
4%
-3%
USA JAPAN GERMANY ITALY UK SPAINFRANCE
11. Healthcare & Life Sciences Review: France 11www.pharmaboardroom.com
DRUG PRICES
Dominque Giorgi, CEPS
HCLS: The Sovaldi case has focused public
attention on the pricing of drugs in France. To
what extent are such drugs a game-changer and
what does it mean for pricing agencies around
the world?
DOMINIQUE GIORGI (DG): The price level at
which the Hepatitis C product Sovaldi was set in
2014 led to a certain level of tension between CEPS
and the pharmaceutical industry. Many people felt
that the price demanded for such a drug was unac-
ceptably high. At CEPS we have managed to ensure
that such innovative products are available to all
patients who are in need of them. Through nego-
tiations, we obtained a considerable discount from
Gilead Sciences for Sovaldi, obtaining a lower price
than the four other most established pharmaceu-
tical markets in Europe (Germany, the UK, Spain,
and Italy). CEPS agreed a price of EUR 13,667 (USD
15,359) per 28-tablet pack; around EUR 5,000 (USD
5,620) lower than the initial list price, as well as re-
bates on the drug’s cost in cases of treatment failure
and performance. But this is not sufficient. For the
first time, we had a product that per unit was very
expensive; comparable to products treating cancer
and rare diseases despite the fact that hepatitis C is
not a rare disease. There are almost 300,000 people in
France in need of this treatment. We therefore had to
put a system in place to lower the overall expenses for
such medicines and maintain our budget for 2015.
We had to use a new framework which has been use-
ful not just for limiting expenses, but also as a means
of putting pressure on the industry and allowing us to
successfully negotiate with them.
HCLS: Is the public ready to accept the cost of
such products? What can be done to better explain
the need for such drugs and how they ultimately
benefit the community?
DG: I think we are already at the limit of the pub-
lic’s comprehension regarding this issue. The public is
very accepting and understanding of the high costs of
medicines for conditions that are very rare, where only
a handful of patients are affected, and the burden on
public health is still comparatively light. The problem
is when the cost of a drug is very expensive and the
overall expenditure is also very high.
The fundamental questions the public wants to ask
are simple: how do pharmaceutical companies define
their pricing policies? Is it through the costs of produc-
tion, the costs of research, or supply chain and logis-
tics? How are such costs calculated? For us to maintain
this delicate balance between public benefit and phar-
maceutical profits, there cannot be a company that sets
prices that are much higher than the norm.
Preface: Former President of CEPS, the French pric-
ing agency, reveals the issues around the launch of the
hepatitis C drug Sovaldi in 2014 and of CEPS´ role in
ensuring that innovative products are available to all.
INNOVATION
FOR ALL
12. 12 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
Preface: Claude Le Pen, a leading consultant to IMS,
reveals French healthcare’s specificities and its two strategic
directions: increasing reliance on private funding and a break
with the principle that everybody should be reimbursed to
the same extent. He also discusses the biosimilars revolution
–a reason for substantial optimism.
NEW DEVELOPMENTS IN HEALTHCARE
Claude Le Pen, IMS Health
THE
METAMORPHOSIS
OF FRENCH
HEALTHCARE
insurance. Increasingly the private health system will
enter the public domain. It will no longer be seen as
complementary but basic insurance. We will see an
integration of the French healthcare system, with
a public system for emergency and costly care, and
a private one for other types of care. We will have a
more egalitarian level of care, covering most hospi-
tals and costly diseases, and for all other issues peo-
ple will rely on private coverage. This will take place
HCLS: What do you see as the main trends in
the French healthcare system?
CLAUDE LE PEN (CLP): The French healthcare
system is moving in two main strategic directions.
First, we are increasingly relying on private funding
through complementary health insurance. In France
we have a two tier healthcare system, a private sys-
tem alongside a public one, with 98 percent of the
population being covered by both private and public
13. Healthcare & Life Sciences Review: France 13www.pharmaboardroom.com
CLAUDE
LE PEN
Consultant, IMS
Health, France
without transferring the governance of the system.
The state will regulate private health insurance to
ensure that there is equal access among patients.
Starting from January 1st
2016 there will be a new
law which will make it compulsory for all companies
to provide all employees with a basic level of health
insurance, irrespective of the size of the business. We
are creating a second universal level of healthcare,
but this time it will be private.
The second big strategic shift in France is a break
with the egalitarian principle that everybody should
be reimbursed to the same extent irrespective of
income. This has already started with family pen-
sions where for the first time it has been made income
dependent. This is a substantial shift, driven not by
ideological reasons but by economic ones.
HCLS: France is still the fifth largest pharma-
ceutical market in the world and the second larg-
est in Europe. What are the advantages that come
with the French healthcare system?
CLP: France has a high quality of medical staff
and a strong scientific medical base. France also has
good access to innovative healthcare. It would not
be politically credible to see a strong reduction in
access to medicines. People see it as the job of gov-
ernment to ensure that the latest innovative drugs
are made available through the healthcare system.
This culture of demanding access to unlimited and
universal healthcare, where price is not an excuse, is a
considerable asset to France. The quality of the peo-
ple working in our administrative bodies is also ex-
tremely impressive. Such people share some common
values, linked to the importance of universal access
to healthcare. The importance attached to universal
access comes not only from the French population as
a whole, but the beliefs of this layer of the French ad-
ministration. There is a relatively homogenous body
of civil servants that defend the same principles no
matter which political party is in charge. There is a
sense of the state, above politics, in France. In the
US there is a single world for government, meaning
both the administration and the state. In France we
take a very different approach. We make a clear dis-
tinction between politicians and the state. The future
of France is not in the hands of politicians but the
upper echelons of the civil service. This can some-
times be problematic given that they are often not
very familiar with the private sector and how private
companies work. But it also brings with it some ad-
NEW DEVELOPMENTS IN HEALTHCARE
Claude Le Pen, IMS Health
14. 14 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
NEW DEVELOPMENTS IN HEALTHCARE
Claude Le Pen, IMS Health
any differences between it and its reference medicine
will have to be proven not to effect safety or effec-
tiveness. It is an emerging field with tremendous
potential across the entire world. With a number of
products coming off patent in the next few years, the
competition around price will be fierce. It is difficult
to estimate the exact amount of savings that can be
made through biosimilars as it is not a stable mar-
ket. Nevertheless, we have estimated that biosimilars
could save France between EUR 500 million and 1
billion by 2020. I am convinced that biosimilars are a
new paradigm. They are not innovative products, nor
generic or OTC products, but an entirely new busi-
ness model. Biosimilars can make a crucial contribu-
tion to healthcare cost control and to the funding of
coming costly innovation.
vantages, notably helping to guarantee certain fun-
damentals of the French healthcare system.
HCLS: Despite negative growth in 2015, are
there reasons to be optimistic for the French
pharma market?
CLP: Yes! In the early 2000s we were able to finance
the first target therapies due to generics, providing
savings that helped to finance new innovations. The
biosimilar revolution currently underway can pro-
vide some substantial savings. A biosimilar is a bi-
ological medicine that is developed to be similar to
an existing biological medicine. Biosimilars are not
the same as generics, which have simpler chemical
structures and are identical to their reference medi-
cines. When approved, a biosimilar’s variability and
SynerlabSource of synergies
Yourpartnerin EuropeforContract
DevelopmentandManufacturingServices
Groupe SYNERLAB
ZI de Krafft
67150 ERSTEIN • FRANCE
sales@synerlab.com
www.synerlab.comwww.synerlab.com
Analytical and Galenical Development
Regulatory support and Dossiers
Solid forms : soft gel and hard capsules, tablets, sachets and stick powder
Liquid forms : sterile liquids with or without preservative, syrup,
liquid sticks, ampoules, injectables
Freeze drying
External use : creams, gel, ointments
Imaginer la vie
sans allergie
www.alk.fr
15. Healthcare & Life Sciences Review: France 15www.pharmaboardroom.com
GENERICS
Comparative Overview
NUMBER OF MOLECULES SOLD BY THE TOP 10 GENERICS MANUFACTURERS IN EACH COUNTRY
PUBLIC CONFIDENCE IN GENERICS ACROSS EUROPEAN MARKETS
Source: GEMME.
25%
ItalyFrance
31% 38%
SpainPortugal
46%
Romania
65%
Germany
75%
GENERIC PENETRATION IN 6 EUROPEAN COUNTRIES
Source: GEMME.
Source: Etude Linkfluence/European Generics Association (EGA)
1800
1600
1400
1200
1000
800
600
400
200
0
N
O
RW
AY
271 272
364 395
462 496 523 527 566 575
632 667 670 685 710 719 720
830 842 878
1,037
1,143
1,351
1,633
1,472
577 623605594
G
REECEESTO
N
IA
SLO
VEN
IALATVIA
DEN
M
ARKCRO
ATIASLO
VAKIA
LITHUAN
IAFIN
LAN
D
BULG
ARIA
SIW
TZERLAN
DRO
M
AN
IASW
EDENBELG
IUM
UK
HUN
G
ARY
CZECH
REPUBLICIRELAN
D
AVERAG
E
EURO
PERUSSIAAUSTRIAPO
LAN
D
PO
RTUG
AL
SPAIN
ITALY
N
ETHERLAN
DSFRAN
CE
G
ERM
AN
Y
HIGHER LEVEL OF TRUSTLOWER LEVEL OF TRUST
UKIRELAND
FRANCEITALY SPAIN PORTUGAL GREECE
ROMANIA
16. 16 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
INDUSTRY COORDINATION
Mobilising for Change
G5 Health acts as a think tank bringing together leaders
of the major health and life science enterprises across
France: namely bioMérieux, Guerbet, Ipsen, Théa, LFB,
Pierre-Fabre, Sanofi and Servier. These companies have
all selected France as the base for their international
development and designated research and development
(R&D) as core priorities . Each maintain a shared ambi-
tion to continue investing and producing national-
ly while simultaneously establishing a global presence
within the sector.
G5 Health members share 5 commonly held ambitions:
gain recognition for the crucial contribution of the life
sciences to public health in France,
help restore France’s competitive position,
make a strong commitment to excellence in French
bio-medical research,
improve patient access to health solutions,
support the biotechnology and new technology
sectors.
G5 Health companies currently possess 110 sites in
France, including 33 R&D and 56 production centers,
which support the economy of many regions across the
country. These industrial centers develop health solu-
tions for the global market across all stages of patient
care, from prevention and diagnosis to treatment
and follow-up, as well as a wide range of innovative
technologies (including molecular biology, biotechnol-
ogy, chemistry, medical devices and medical imaging).
Every year, more than € 3.2 billion is invested by the G5
Health companies in R&D in France, accounting for a
full 63% of their sales in France.
The diversity of these sites, their innovation capabil-
ities and international dimension position France as a
net exporter of health solutions, with a trade surplus of
€ 7.7 billion.The member companies of G5 Health also
maintain a strong presence in the international market
and have become key players in their domains across the
globe. The G5 further constitutes major global stake-
holder with sales valued at € 43.4 billion and invest-
ments in R&D totaling € 6.3 billion every year.In all, the
G5 Health companies employ nearly 160,000 people
around the world. This includes 46,500 people in France
(10,800 in R&D and nearly 20,000 in production).
Marc de Garidel, Chairman and CEO of Ipsen,
Vice-President of France’s Healthcare Industries and
Technologies Strategic Committee, and Chairman of
the G5 Health, commented: “The G5 Health has gained
a prominent reputation as proactive organization and
force for change. It campaigns in favor of policy in France
to promote, retain and develop a strategic health sector
in terms of the industry, jobs, innovation, and exports.
We welcome a transparent and constructive discussion
with all stakeholders and public authorities to strength-
en France’s position as a global leader in life sciences.”
INTRODUCING “G5 HEALTH”
bioMérieux · Jean-Luc Bélingard Guerbet · Yves l’Epine Ipsen · Marc de Garidel Théa · Jean-Frederic Chibret
LFB · Christian Béchon Pierre Fabre · Bertrand Parmentier Sanofi · Olivier Brandicourt Servier · Olivier Laureau
18. 18 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
HCLS: 2015 was an important year for Ipsen, why?
MARC DE GARIDEL (MdG): We have pursued our
focused strategy in 2015 and achieved important steps
forward. Besides an excellent 2015 operating perfor-
mance, sales grew by more than 10%, driven by the suc-
cessful launch of Somatuline in neuroendocrine tumors
in the US and Europe, and the sound Dysport perfor-
mance in aesthetics. Core operating income grew by close
to 24%, reflecting our continuous transformation and
cost monitoring efforts. 2015 was also marked by take-
off in the US ahead of plan. It has been Ipsen’s best sales
growth since we first became a publicly traded company
10 years ago.
Somatuline had more than 30% growth globally with
a US growth increase superior to 111%. In 2014, we hired
around 100 people in oncology in the US. That same year
we received the FDA approval for Somatuline, with a very
successful launch in the following year. In 2014, just 5%
of our global sales were derived from the US. In 2015,
it is 11%, and by 2016 it will overtake France to become
our number one affiliate. In the future, we will be con-
ducting further business development deals and possible
acquisitions, complementing our portfolio in the US and
building on our growth momentum.
In Europe we continued to expand the brand, gaining
a three-point market share within the NET field, and are
at 44% market share,
HCLS: Brazil is going through a serious crisis, the
Russian ruble has taken a hit, and increased Chinese
regulation may limit future growth. What are your
objectives for the year regarding emerging markets?
MdG: Despite short-term challenges, Ipsen remains
committed to emerging markets which today comprise
37% of total sales. While this share will decrease slightly
with the growth of our US business, it will remain an im-
portant contributor to the Group.
The Board of Directors made the decision to accelerate
our investments in China to better support Decapeptyl,
our prostate cancer and fertility product. We are also
investing in primary care and hiring over 100 reps for
Smecta, a treatment for acute and chronic diarrhea and
digestive pain. Our ambition is to continue with dou-
ble-digit volume-based growth in China, Ipsen’s number
two affiliate globally.
In Russia, we have been hit by the fall of the ruble but,
contrary to expectations, in 2015 grew in terms of both
volume and in the local currency. When I joined Ipsen five
years ago, we were growing by 30% in Russia; today we are
still growing, even if only by single digits. We also have
strong momentum in Brazil, where Dysport has over 50%
market share. New launches will come soon.
IPSEN’S INTERNATIONAL STRATEGY
Marc de Garidel, Ipsen
Preface: Marc de Garidel, Chairman and CEO of Ipsen,
discusses the company’s best year since going public,
take-off and growth in the US, and emerging market
strategies.
GOING BIG
STATESIDE
By 2016 [the US] will overtake
France to become our number
one affiliate
MARC DE GARIDEL, IPSEN
“
“
19. Healthcare & Life Sciences Review: France 19www.pharmaboardroom.com
SPOTLIGHT ON A RISING STAR
Marc de Garidel, Ipsen
IPSEN IN FOCUS
All data source: Ipsen.
IPSEN EXPANDS
ITS TEAMS
SALES THERAPEUTIC AREA
AND PRODUCT IN 2015/2014
(IN MILLION EUROS) 2015 2014 % VARIATION
AT CONSTANT
CURRENCY
SPECIALTY CARE
ONCOLOGY 752.8 620.1 17.3%
NEUROSCIENCES 280.7 255.0 10.0%
ENDOCRINOLOGY 80.7 71.9 9.6%
SPECIALTY CARE TOTAL 1,114.2 947.1 14.4%
PRIMARY CARE
GASTROENTEROLOGY 227.2 219.3 -0.7%
COGNITIVE DISORDERS 52.0 62.6 -11.2%
OTHER PRIMARY CARE 26.2 30.1 -13.1%
DRUG-RELATED SALES 24.3 15.9 52.5%
PRIMARY CARE TOTAL 329.7 327.8 -1.1%
GROUP SALES 1,443.9 1,274.8 10.4%
4,600
EMPLOYEES TODAY
485
NEW RECRUITS IN 2015
59%
OF THE COMPANY'S
EMPLOYEES ARE WOMEN
41
YEARS AVERAGE AGE
R&D BUDGET
R&D INVESTMENT
€192.6M
(13.3% of sales)
SALES BY GEOGRAPHIC AREA
38%
Major western
European*
22%
Other European
countries
11%
North America Rest
of the world
29%
* Major western European G5: Germany, France, Italy, UK, Spain.
20. 20 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
HEALTHCARE LOGISTICS
Accelerating into the Future
PHARMACEUTICALS
ON THE MOVE
Preface: Pharmaceuticals do not appear in pharmacies and hospitals out
of nowhere, yet the logistics of transporting these goods are a seldom ac-
knowledged component of the healthcare industry supply chain. Behind
the scenes, several French players are stepping up to the plate with new
services and certifications to meet the demands of today’s globalizing phar-
maceutical market.
he global healthcare
industry is at a critical
juncture: global popu-
lation is growing, and
the median age is rising.
The growth of the middle class in
emerging markets is also surging,
creating markets of millions of
new customers and patients. The
demand for healthcare has never
been greater, and the entire world
is now a marketplace.
To meet this rapid increase in
demand, pharmaceutical compa-
nies should be moving fast to make
strategic changes to their supply
chains and capitalize on new oppor-
tunities. But supply chain change
is slow. The winners of tomorrow’s
healthcare marketplace will be the
companies that have created agile,
efficient, and flexible supply chains,
and many leading French players
have made sure to position them-
selves ahead of the curve. These
logistic service providers have tak-
en action to make strategic supply
chain changes.
When considering the supply
chain of the healthcare and phar-
maceutical industry, it is easy to
concentrate on research and devel-
opment initiatives, or end-user
experience, with products readily
available at pharmacies or in hos-
pitals. However, inbetween these
phases, a component that is often
neglected is shipment and logis-
tics. When handling highly sensi-
tive materials such as live cultures
and drug molecules, there are much
greater components of care neces-
sary than simply shipping packages
via standard post. Requiring spe-
cialized care, including tempera-
ture controlled shipment methods,
healthcare logistics is an exceedingly
nuanced and technical subset of the
industry
Highlighting the specialized ser-
vices necessary to cater to the heath-
care and pharmaceutical sector,
Geraldine Devillers, Healthcare Key
Account Manager at Chronopost,
outlines the protocol of the lead-
ing French postal service provider.
Known locally as Chronopost with
La Poste as a primary stakehold-
er, the company is globally recog-
nized under the name DPD Group.
With healthcare related parcels
making up nearly 15 percent of
Chronopost’s global volume and
growing, Devillers shares that the
company is “very well known now
throughout the healthcare industry
in France.”
Naturally, if pharmaceuticals,
drugs and vaccines are not proper-
ly transported, they can be damaged
and therefore become unusable
and even hazarous for patient care.
Particularly where brand reputation
and quality control are at stake, cold-
chain solutions – the use of tempera-
ture controlled shipment conditions
– are becoming vital throughout the
industry. “Temperature control is
frequently a key concern and priority
of our clients,” shares Devillers, not-
ing the commitment Chronopost
has made to temperature controlled
services. “Considering the very
sophisticated logistics necessary,
T
21. Healthcare & Life Sciences Review: France 21www.pharmaboardroom.com
HEALTHCARE LOGISTICS
Accelerating into the Future
particularly in the shipment of tem-
perature-controlled pharmaceuti-
cals or hazardous materials, there
are great precautions that must be
met, including cold-chain packag-
ing, compensating for fragility, and
meeting the needs of highly unpre-
dictable shipment orders.” To main-
tain the utmost quality assurance
for clients, Chronopost conducts
temperature campaigns, accompa-
nying parcels with data-loggers to
track temperatures throughout the
shipping procedure.
Whereas Chronopost may be
a leading service provider on the
ground, another, perhaps unex-
pected, French player is bringing
pharmaceutical logistics to the skies.
Air France-KLM-Martinair (AFKLM
Cargo) has become the first airline
group to achieve IATA’s Center
of Excellence for Independent
Validators (CEIV) certification for
pharmaceutical handling. AFKLM
Cargo Director of Pharma, Renate
de Walle, remarks that the cer-
tification is “a significant mile-
stone for our airline group since
it reassesses the ongoing focus on
innovation and improvement of
our global pharma network pro-
cesses and facilities, serving as a
further enhancement of AFKLM
Cargo’s global pharma network
capabilities.”
The CEIV program was developed
to improve the operational and
preparedness procedures when
dealing with pharmaceuticals,
and to also counter the decline
of air cargo’s market share of
global pharma product trans-
port. “Pharma is a top priority for
AFKLM Cargo because it deals
directly with people’s health. It
is all about patients.” AFKLM
Cargo currently maintains two
major warehouses and two oper-
ations systems with closed cold
chain capabilities, ready to meet
the needs of customers and trans-
port products safely across long
distances.
Pharmaceutical logistics is still
a developing sector of the indus-
try, with a large opportunity for
growth and expansion. The sector
is already a USD 70 billion global
market growing at an annual rate
of four percent. Cost management
for companies, as well as assistance
in navigating foreign regulatory
frameworks are both elements of
support that logistics service pro-
viders are able to offer. Whereas
many large companies still attempt
to conduct logistics management
internally, companies that embrace
collaboration may be able to focus
more on their core competencies -
that is, research and development,
and producing drugs – if they leave
the logistics work up to companies
that not only specialize in the ser-
vices, but also exercise high quality
standards of quality.
Pharma is a top priority for AFKLM Cargo
because it deals directly with people’s
health. It is all about patients.
RENATE DE WALLE, AFKLM CARGO
“
“
22. 22 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
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23. Healthcare & Life Sciences Review: France 23www.pharmaboardroom.com
COVER STORY
La French innovation!
France
“It’s impossible to think about
healthcare and not think about
France,” declares Muriel Pénicaud,
CEO of Business France, the nation-
al agency charged with supporting
both inward investment in France
and expansions by French businesses
into other markets. “It’s not only the
sheer size of our market that makes
it so attractive, but also the fact that
it is so really well-structured,” she af-
firms. Indeed, France’s legacy in the
healthcare and life sciences field cer-
tainly looms large with an enviable
track record for premiere-ing state
of the art innovations such as the
creation of the first artificial heart
and a formidable network of glob-
ally acclaimed medical universities
and research institutions that have
produced numerous Nobel prize
winners. “Size is our first asset: we
rank consistently among the top 3
globally in fields such as medicine,
medical devices and pharmaceuti-
cals and are 1st in the pack in Europe
for animal health and vaccinations.
Secondly, the depth of innovation
that can be found is quite simply im-
peccable with a full 9 percent of our
foreign investment directly attribut-
ed to R&D. Thirdly we enjoy a solid
manufacturing base with a strong
culture of re-exportation, as well as
a great logistical platform for trans-
portation and distribution,” proudly
recounts Pénicaud.
La French
innovation!
24. 24 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
et the “golden age
of pharma companies
is now drawing to a
close and the rules of
the game are under-
going considerable change” in
the words of Francois Sarkozy,
a prominent and well-respect-
ed authority on the local mar-
ket. While France may still lay
claim to one of the most com-
plete healthcare systems in the
world, priding itself on offering
both universal and unlimited
access to the latest innovations;
dark question marks over its long
term sustainability and viability
abound. Many commentators see
such a system as “ill-equipped for
an era characterised by escalat-
ing drug development costs and
ageing populations” and fear that
the complacency of former glo-
ries masks an “erosion of pharma
manufacturing and export com-
petitiveness” and “failure to con-
vert ingenuity in creativity into
commercialized innovations.”
Similar concerns were raised
during the recent discussions of
the 7th assembly of the Strategic
Council of Health Industries
(CSIS), an annual encounter
between Prime Minister Manuel
Valls, relevant ministers and 45
senior industry stakeholders
including the so called ‘G5 Santé’
of top French Pharma industrial-
ists (bio- Mérieux, Guerbet, Ipsen,
LFB, Pierre Fabre, Sanofi, Servier
and Théa). Noting that France, a
one-time uncontested leader of
THOMAS
FATOME
director, Direction
de la Securite Sociale
MURIEL
PENICAUD
CEO, Business
France
European pharmaceutical produc-
tion has now slipped to a lacklus-
tre “6th place behind Italy,” the
grouping resolved to “redouble
efforts to increase the visibility of
in-country biologics manufactur-
ing capabilities, to cultivate inno-
vation and to restore competitive-
ness once more.”
INTERNATIONAL COMPARISON OF HEALTH EXPENDITURE AS A SHARE OF GDP
Source: OECD Health Data 2015.
USA
JAPAN
DENMARK
18
16
14
12
10
8
6
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
UK
GERMANY
FRANCE
Y
25. Healthcare & Life Sciences Review: France 25www.pharmaboardroom.com
COVER STORY
La French innovation!
PATRICK
ERRARD
general manager
Astellas France &
president of LEEM
PHILIPPE
LAMOUREUX
general manager,
LEEM
WINDS OF CHANGE
“From a pure quality perspec-
tive, if I were a patient today,
there would be one country that
I would want to be treated in, and
that would be France”, exclaims
Jean-Luc Bélingard, chairman
of the number one microbiol-
ogy diagnostic company in the
world, bioMérieux. Blending the
principle of universal access with
unlimited innovation, France’s
iconic healthcare system has long
been a source of immense pride to
patients and practitioners alike,
but the winds of change are now
resonating loudly, and French
public health provision, with its
penchant for generous coverage
of cutting-edge drugs and medi-
cal devices, is undoubtedly com-
ing under increased strain.
Analogous to the fo rc-
es underway in other Western
European markets, France’s phar-
ma industry is today finding
itself increasingly subjected to
cost-containment drives as poli-
cymakers grapple with the unsus-
tainability of ballooning drug
expenditures. “Our industry has
certainly gone through some dif-
ficult budget cuts over the last
few years. Five years ago, the con-
tribution of pharma to cost-con-
tainment policies stood at about
EUR 500 million (USD 565 mil-
lion) per year. Today, it is EUR
1 billion (USD 1.13 billion) per
year with the industry contribut-
ing roughly double that of 2011,”
laments Philippe Lamoureux, gen-
eral manager of Les Entreprises
du Medicament (LEEM), the only
professional industry associa-
tion representing pharmaceutical
industry players locally.
Some would suggest that the
recent flurry of new molecules
and highcost breakthrough med-
ications being brought to mar-
ket actually pose an existen-
tial threat to the French model
itself by demanding a different
response from both the authori-
ties and industry alike. As Vincent
Bildstein, general manager of IMS
France, explains: “New tools are
required to manage the budgetary
A C
Photo Courtesy of Servier.
26. 26 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
to USD 84,000 per course in the
United States. Meanwhile, Marisol
Touraine, minister of social affairs
and health, has insisted that the
French health insurance system
covers 100 percent of the price of
the drug, so as to ensure that it is
affordable for citizens with HCV
infection. For Mr Fatome, pro-
viding universal access to such
a product is highly gratifying: “I
am most proud to live in a coun-
try which, in 2014, enabled some
11,000 Hepatitis C patients to
gain access to the most innovative
treatment available, and to ulti-
mately, be cured,” he enthuses. Yet
for Mr Fatome this episode had
one particularly disappointing
feature: the inability to cooperate
with European partners regarding
the pricing of such drugs. “France
attempted in vain to place this
subject on a political European
level in 2014… in the future, we
will have similarly expensive drugs
coming to market and I hope, that
time round we can resolve around
aspects of the reimbursement of
a drug…Any company that genu-
inely wishes to establish itself in
this constrained climate will face
obstacles to demonstrating the
value of their drugs. The pressure
is on for defining fresh strate-
gies and alternative approaches.”
To his mind, change is becom-
ing inescapable. “With a declin-
ing healthcare budget juxtaposed
against an evergrowing demand
from the market, France will sure-
ly face many difficult choices in
the coming years and months,”
he remarks. The facts themselves
would appear to back up this
sense of structural in-equilib-
rium: the country’s total social
security revenue (which naturally
also encompasses retirement and
pensions) today extends to a hefty
EUR 200 billion (USD 226 billion)
per year meaning that social secu-
rity expenditure now outpaces
even GDP.
Yet, even in the face of
such stark challenges, there
PHILIPPE
LUSCAN
executive vice
president, Global
Industrial Affairs
and president of
Sanofi France
MARC-ANTOINE
LUCCHINI
president-general
manager, Sanofi
France
OLIVIER
LAUREAU
president, Servier
Group
nevertheless remains strong polit-
ical will to ensuring that the prin-
ciple of high access to innovation
is maintained. “Other European
countries may be cutting costs
by limiting access to the latest
innovations, but France will cer-
tainly not contemplate following
down this path,” declares Thomas
Fatome, director of the Social
Security. “It is the nature of our
job both to manage the deficit
while at the same time guarantee-
ing the financing of latest innova-
tions,” he reasons.
New hepatitis C treatments
have been a regular feature in
healthcare news of late, not least
because they offer that most elu-
sive of gifts: a cure. In 2014, the
French government proudly pro-
claimed it had struck a deal with
Gilead Sciences offering Sovaldi
at the lowest price in Europe.
France’s negotiation meant that
a typical 12-week course of the
drug would cost a mere EUR
41,000 (USD 51,000), compared
Other European countries may
be cutting costs by limiting
access to the latest
innovations, but France will
certainly not contemplate
following down this path
THOMAS FATOME,
DIRECTION DE LA SECURITE SOCIALE
27. Healthcare & Life Sciences Review: France 27www.pharmaboardroom.com
COVER STORY
La French innovation!
basis. “Beyond pricing per se, we
must hold constructive discussions
on how to better fund innovative
drugs” insists Jerome Bouyer, gen-
eral manager of AbbVie France
who was also recently appoint-
ed chairman of the committee of
scientific affairs at LEEM. “When
analyzing this year’s drug envelope
voted upon by the Parliament, it
turns out to be one percent nega-
tive in relation to the year before.
This comes about as a result of
the infamous ‘L-Tax’ where, in the
event we go above negative one
percent on our drug spending, we
get taxed. That, in turn, ends up
as a sentencing to decrease capa-
bilities, and acts detrimentally
to growth, which stems primari-
ly from innovation, “ he laments.
“From our perspective, this is a
deliberate punishment to innova-
tion, and ensures stagnation across
the market. The healthcare sector
allowed growth (ONDAM) is +1.75
percent annually but drug compa-
nies are held at negative one per-
cent growth,” he adds regretfully.
some Europe-wide initiatives,”
he reflects.
FAIR PRICE
FOR INNOVATION?
A lack of transparency in the way
that end-prices for new drugs
are negotiated has now become a
recurrent bugbear. For Dominique
Giorgi, former president of
France´s pricing agency, the
Comité Economique des Produits
de Santé (CEPS), “Many of the
MICHEL
GINESTET
Global Innovative
Pharma BU head
and president, Pfizer
France
PHILIPPE
BARROIS
CEO, Novartis
France
innovation & industrial know-how
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fundamental answers demanded
by French citizens relate to how
pharmaceutical companies are
going about defining their pric-
ing policies.” “For us to maintain
this delicate balance between pub-
lic benefit and pharmaceutical
profits, there cannot be a compa-
ny that sets prices that are much
higher than the norm,” he reasons.
Yet for many, the real issue at stake
goes well beyond upfront costs and
includes a systemic failure to cap-
ture the entire spectrum of bene-
fits that innovative products can
potentially deliver over a long-term
28. 28 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
term. Such a strategy will adverse-
ly impact the system over the
long-run, in terms of investment,
research, innovation and overall
economic growth.”
Adding to an already complicat-
ed picture is another issue: public
perception of pharma companies
has plummeted to an all-time low,
while at the same time the costs of
production have never been high-
er. “The biggest challenge we have
as an industry is to improve our
image” reflects Michel Ginestet,
Global Innovative Pharma (GIP)
business unit head and president
of Pfizer France. One event in par-
ticular, the so-called Mediator
affair, in which a weight-loss drug
appeared to provoke unintended
side-effects has marked the local
industry profoundly. “The cham-
pioning of the pharma industry as
a national asset was questioned,”
claims LEEM´s Mr Lamoureux, “I
tend to say that there is a before
and after Mediator period.”
For Francois Sarkozy, president
and founder of FSNB Health &
reimbursements already account
for 15 percent of total reimburse-
ment in this country; yet when we
look at the authorities’ cost-sav-
ing measures, we are expected to
contribute around half of total
savings. France is a country with
one of the best healthcare systems
in the world and it would be abso-
lute madness to undo such a sys-
tem for purely shortterm gain,” he
retorts. Philippe Barrois, CEO of
Novartis France, concurs with such
a view: “the current dependency
on industry as the main source of
savings can only work in the short
With more medical breakthroughs
forecast to arrive in the market
over the coming years, the issue
of access to innovation will clear-
ly not disappear. One company
with ambitions to embark upon
an unprecedented rhythm of inno-
vation creation is Servier, with its
transformational plan to launch
one new molecule every three years.
According to Olivier Laureau,
Servier´s CEO as of April 2014:
“The pharmaceutical industry can-
not be expected to bear the heaviest
burden when it comes to reducing
the overall budget deficit. Drug
JÉROME
MARTINEZ
president, Santen
France
DENIS DELVAL
senior vice president
Europe West and
South, general
manager France,
ALK
CORPORATE AP FOCUS NOV 2015 VOK.indd 1 03/12/2015 11:33:39
29. Healthcare & Life Sciences Review: France 29www.pharmaboardroom.com
COVER STORY
La French innovation!
industry so renowned for its crea-
tivity, has managed to craft a very
particular response to problemat-
ics of market access for new inno-
vations that have been afflicting
other mature, Western European
healthcare systems. As Jean-Luc
Harousseau, former Chairman of
the Haute Autorité de Santé (French
National Authority for Health)
explains, “Public healthcare pro-
vision in France remains highly
generous in delivering equal access
to all patients, whether indigenous
or foreign, while simultaneous-
ly affording rapid access to inno-
vation through the ‘Autorisation
temporaire d’utilisation’ (ATU)
the pharmaceutical industry and
[isolated incidence of misdemeanor
or negligence] that the media tend
to focus on.”
However, France is certainly not
an exception to the rule here, as
Patrick Errard, general manager
of Astellas France and president of
LEEM is quick to point out: “The
pricing of innovation is a worldwide
issue, not a specifically French one.
The pharmaceutical industry glob-
ally has to take into account what is
the fair price of innovation… it’s an
issue that we can simply no longer
afford to ignore.”
Yet, the French regulatory appa-
ratus, perhaps befitting a local
Care, a healthcare consultancy,
there remains a serious issue sur-
rounding public perception that
requires correction. “The pharma-
ceutical industry is all too often
wrongly portrayed as the ‘bad
guy.’ When instances of misbe-
havior occur, they obviously need
to be sanctioned, but in my expe-
rience working at all levels of the
local pharmaceutical industry, the
vast majority of practitioners are
most definitely in it for the right
reasons.” The President-General
Manager of Sanofi France Marc-
Antoine Lucchini notices, “a strik-
ing discord between the real pride
that people feel to be working for
Photo Courtesy of Servier.
30. 30 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
LOOKING BEYOND THE FAMI-
LY WHILE RETAINING THE HA-
LLMARKS OF A SYSTEM THAT
HAS ATTAINED SO MUCH SUC-
CESS: Stéphane Thiroloix, joined
Mayoly Spindler as CEO in Sep-
tember 2014, after a career in big
pharma. He speaks of the need
to strike a fi ne balance between
respecting the working culture of
a family-owned business and im-
plementing norms deployed in large corporate entities.
“Large companies and big pharma are stereotypically
assumed to exert high pressure on results. Symmetrica-
lly, there is an assumption that privately-owned compa-
nies are gentler; In many ways they are, but it is wrong
to translate that into an absence of results-orientation.
In fact, the incarnated reality of the shareholding family
can be seen as additional pressure to deliver vs the ra-
ther distant existence of speculative investors. A culture
of high standards and a reasonable sense of urgency
are therefore perfectly compatible with a family-owned
environment. An interesting idiosyncrasy of family run
companies is indeed that there is not a single question
that does not merit going right back to the owner! My
challenge is always to push decision making to the ed-
ges… Contrary to publicly traded entities, family-ow-
ned companies are generally under little pressure to
disclose data, and inertia tends to sway towards little
information fl ow. For the owners it is more than simply
about sales – this is a company that is connected to its
family history and rooted and embedded as a source
of jobs within the fi ber of the local community. Our
ambition is to raise our sights towards becoming a re-
ference internationally in the fields of gastroenterology
and dermo-cosmetics.”
THE MECHANICS OF REACHING FURTHER AFIELD:
The story of the Chibret family in ophthalmology be-
gan with Paul Chibret, a young military doctor, at the
end of the Second Empire. This visionary became the
originator of an industrial saga that continues to this
day, namely Laboratoires Théa. Unlike many other phar-
maceutical companies, Théa is 100 percent focused on
ophthalmology and is the only Pan-European ophthal-
mic company to have its headquarters in Europe. Today
over 80 percent of their revenues are derived from their
European subsidiaries, which have been established
over the last 15 years, with France accounting for under
30 percent. Yet conquering the US market is another is-
sue. “The big challenge concerning the US is not obtai-
ning FDA approval, but rather a commercial jump, given
that competition is particularly strong”, reveals Jean-Fre-
deric Chibret, president of Laboratoires Théa. “At the
moment our strategy is to con-
centrate on Europe, where we are
the number three player behind
Novartis and Allergan. We are sti-
ll quite a young company and we
need to consolidate our presence.
There is still strong potential to in-
crease business in countries such
as Germany and the UK. We are
also looking at starting up busi-
ness in a country such as Iran, and
to develop a presence in Asia,
where we have little presence as
of yet. We must ultimately reach out beyond Europe,
step by step as we cannot do everything at the same
time! Once you establish a presence in a given country, it
takes at least two to three years to launch your fi rst pro-
duct. Over the last 15 years, we have sometimes started
in a country from scratch, which is a lengthy process, and
we sometimes were able to acquire an existing company,
which speeds up and short-circuits the process conside-
rably as you already acquire existing turnover and re-
sources. We have already gone through this inorganic
route in the Netherlands, where we acquired a specific
portfolio, as well as in the Nordics, Turkey and Austria.
This could well be the approach we adopt in the US.”
Blossoming of the home-grown champions
France is renowned for its pharmaceutical entrepreneurial dynasties from the Servier, Fabre,
Beaufour, Choay, Vernin, Mérieux and Chibret families. We look at some of the challenges
and opportunities facing three of them.
STEPHANE
THIROLOIX
CEO,
Mayoly Spindler
JEAN-FREDERIC
CHIBRET
president,
Laboratoires Théa
31. Healthcare & Life Sciences Review: France 31www.pharmaboardroom.com
COVER STORY
La French innovation!
MAINTAINING MOMENTUM
AND SUSTAINING GROWTH:
Marc de Garidel has been
Chairman & CEO at Ipsen, a
global specialty-driven pharma-
ceutical group, since November
2010. He talks about their achie-
vement in sustaining growth.
“The year 2015 has been Ipsen´s
best year since we fi rst became
a publicly traded company. We
have pursued our focused stra-
tegy and achieved important steps forward. Besi-
des an excellent 2015 operating performance, sa-
les grew by more than 10% year-on-year, driven by
the successful launch of Somatuline in neuroendo-
crine tumors in the US and Europe, and the sound
performance of Dysport in aesthetics. It has been
also marked by our take-off in the US. A notable
highlight has been the approval in the US of a new
indication for Dysport, a treatment for movement
disorders and spasticity. In 2015, the US accounted
for 11 percent of total sales, and by 2016 it could
well overtake France to become our number one affi
liate. Over the next fi ve years, we identify several
key growth drivers. Firstly, the NET market, notably
with Somatuline. Moreover, through our partners-
hip with the Texan based Lexicon, we will be fi ling
in Europe a new product in the NET fi eld, namely
telotristat etiprate, with a focus on the treatment
of carcinoid syndrome. Furthermore, in 2015 we
acquired the German OctreoPharm, a company
with a unique expertise in antagonist peptides for
the diagnosis and treatment of neuroendocrine tu-
mors. This deal was an important step in our am-
bition to become the global leader in the mana-
gement of NETs, and illustrates the pertinence of
our business development strategy. Another main
growth driver will constitute Dysport, where we
need to increase our penetration of the US market.
And fi nally, we also predict a lot of momentum
from cabozantinib, which was recently licensed from
the US company, Exelixis, and demonstrates poten-
tial to become a key oncology product in Europe,
notably for the second line treatment of advanced
renal cell carcinoma.”
MARC DE
GARIDEL
chairman & CEO,
IPSEN
system,” an ingenious mechanism for authorizing
temporary access to stateof- the-art medicines that
serves to circumvent the traditional sluggishness of
the reimbursement process in instances of urgency.
ATU: RED HERRING OR REAL SOLUTION?
One distinctive and eye-catching feature of the
French system is the priority it offers to break-
through innovation. “We are the country that looks
to give patients the widest possible access to inno-
vation. Already we rank as number one for Europe
in this regard and as second in the world behind the
United States,” observes Phillipe Lamoureux. “This
becomes possible in no small part due to our unique
system of ATU which effectively enables patients to
receive drugs well before official market approval,”
he reveals.
The popularity of the ATU is perhaps best under-
scored by the way in which some companies have
reconfigured their business development plans to
make use of the opportunity that it affords. One
company that has benefitted from the ATU system
is the Japanese ophthalmic player Santen, which
first established a presence in France in 2011 with
the acquisition of a local R&D company. “2015 was
a significant year for us, receiving European market-
ing approval for Ikervis, the first cyclosporine drug
for the treatment of severe keratitis in adult patients
with dry eye disease in Europe. In France the prod-
uct was already available through the ATU system
18 months before it received European approval,”
claims Jérome Martinez, president of Santen France.
Not all actors are so effusive in their praise for the
French market’s embracement of innovation howev-
er; just ask Denis Delval of Danish company ALK,
senior vice president for Europe West and South,
and general manager France. “France is a relatively
fair environment for breakthrough innovation. But
32. 32 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
an innovative treatment for hepatic encephalopathy
(HE) which we expect to launch in 2016”, comments
Emmanuelle Ribot-Mariotte, general manager of Alfa
Wassermann Pharma France. “It was foreseen that
France would be one of the earliest countries where we
would launch the product, acting as a primary gateway
to the rest of Alfa Wassermann´s affiliates in Europe.
Unfortunately, the launch of this product has faced
a number of delays.” While today results are back on
track Ms Ribot-Mariotte is in no doubt that “building
a strong affiliate in France, where the legislative envi-
ronment does not allow for much flexibility, takes time
and a lot of persistence.” For many, the authorization
process in France is lengthy and there is also a lack of
transparency that ends up with an added layer of com-
plication. “The French administrative process is based
this is only 10 percent of the new
products coming to market. For
the remaining 90 percent, which
are the vast majority of treat-
ments and patients, the situation
is extremely difficult.” In ALK´s
case their first product to receive
Europewide authorization, Grazax,
was launched in most European
markets by 2007. “France was actu-
ally the last country in which we
brought the product to market, not
until the end of 2010,” he deplores.
Another company to have experienced simi-
lar issues is the Italian outfit Alfa Wassermann.
“We have been working hard on Rifaximin-alpha 500,
www.alfawassermann.com
EMMANUELLE
RIBOT-
MARIOTTE
general manager,
Alfa Wassermann
France
33. Healthcare & Life Sciences Review: France 33www.pharmaboardroom.com
COVER STORY
La French innovation!
with support then available as part of a community” he
notes enthusiastically.
For many, investing in diagnostics is still considered
as a cost and not an investment. Educating and inform-
ing policy makers on the importance of prevention
over treatment has long been seen as essential. “What
we require is a paradigm shift. Treatment should be
seen as a fallback option, when prevention and diag-
nostics have failed,” insists Laurent Amiel, president of
Abbott France. However not all players put the empha-
sis on the authorities in this regard.
Just ask Jean-Luc Bélingard, chair-
man of bioMérieux: “I have been
working in the healthcare industry
since 1974. For the last 40 years the
same concerns have been raised: the
authorities do not properly appre-
ciate the value of diagnostics, they
permanently put pressure on our
prices and augment regulatory con-
straints. I believe that the primary
on three stages: local market authorization, scientific
evaluation by the transparency committee, and finally
analysis by the pricing committee. France is unique in
having these three steps”, points out Mr Delval.
SWITCHING THE PARADIGM FROM
TREATMENT TO PREVENTION
Given that rising costs of health care pose a formidable
challenge for policymakers in France, an option of long-
standing interest constitutes prevention. Of consider-
able importance is what can be done for patients with
no available treatments. “When it comes to the field of
orphan drugs, diagnosis is crucial”, explains Christian
Deleuze, President of Sanofi Genzyme France. “There
are 8,000 rare diseases, and only around 250 specific
treatments. Even though there may be no treatments
for a patient´s specific disease, their quality of life
improves considerably once they have been diagnosed,
CHRISTIAN
DELEUZE
president, Sanofi
Genzyme France
AVERAGE MARKET ACCESS DELAY
PRICE AND REIMBURSEMENT IN NUMBER OF DAYS
Source: EFPIA.
G
erm
any
D
enm
ark
Sw
itzerland
A
ustria
N
etherlands
Sw
eden
B
elgium
N
orw
ay
Spain
Italy
FR
A
N
C
E
Portugal
Poland
800
700
600
500
400
300
200
100
0 0
102 107
131
245
364 368 378 384
432
602
699
443
34. 34 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
overhaul the paradigm regarding the treatment of dis-
ease,” he asserts.
Regardless of who bears primary responsibility, all
agree that investing in increased cooperation across
all stakeholders will be essential moving forward. As
Francois Sarkozy concludes, “my fundamental belief is
that we, the entire healthcare system, need to move from
treating a disease to managing a patient. This can only
happen if there is synergy and coordination between all
responsibility lies with the industry itself, that has not
been able to convey the value of its services.”
Personalized treatment and optimization of treat-
ment approaches also have important roles to play
according to Santen’s Jerome Martinez. “We are our-
selves working on specific algorithms, enabling oph-
thalmologists to diagnose different diseases and then
to decide what specific treatment is most appropriate
in each instance for a specific patient. Our aim is to
One area where Francophone la-
boratories appear to perform es-
pecially well is dermo-cosmetics.
Stories abound of small family-run
ventures pioneering innovative
formulas and over the years ri-
sing to dominate their respective
niches. Laboratories Asepta, for
example, initially came into being
back in 1947 as a provider of foot
cream to croupiers working in the
Monte Carlo Casino who were complaining of aching
legs and feet. Today Asepta boasts global brands such
as Akileïne, an anti-chafing sports cream and Ecrinal,
a cosmetic product for hair and nails and has won in-
ternational acclaim for being one of the first movers
to introduce the use of Shea butter in cosmetics. “We
are now very well known in the sports and diabetics
market,” explains Anne-Marie Noir, Asepta’s CEO thou-
gh she is keen to stress that the company retains its
original ethos and very much remains a business “by
pharmacists for pharmacists”. Despite its global reach,
maintaining the firm’s family history and Monegasque
roots remains of upmost importance to her. “Our local
production unit is one of our iconic assets… if we de-
localize these elements that are some of the strongest
components of our company, it would risk diluting our
brand,” she muses. The task at hand now will be to ex-
tend market reach geographically beyond an already
well-established presence in areas like Egypt and the
Middle East by branching out into technically tough
markets such as China. Her master plan for that is to
“identify and collaborate with indigenous distributors
who are intricately familiar with their home markets and
can simultaneously demonstrate a strong track record.”
Another entity punching above its
weight and one that has proved
similarly adept at dominating its
own niche is the French laboratory,
Expanscience. “I am confident to
say that we are the European lea-
der in pharmacy in dermo-cosme-
tics for baby care and pregnant
woman care, and that despite the
comparative size of many of our
competitors, they simply do not
portray comparable levels of leadership in this subsec-
tor,” declares President, Jean-Paul Berthomé. For, him
it all comes down to specialization and micro targeting.
“The competition is typically centered around the adult
market. We understand that our targeted market is not
large, but it is nonetheless a niche focused on two very
crucial moments of life – pregnancy and child-care. We
strive to design very specific products that cater to the
nuanced needs of the market and to attain recognition
as the uncontested specialist in our domain. For exam-
ple, we have one R&D team specifically focused on
skin typology, crafting solutions specifically for babies
with products designed for dry skin, sensitive skin, and
normal skin,” he explains. The next challenge for Labo-
ratoires Expanscience will again be to prove adept at
expanding the brand out into heavyweight foreign mar-
kets. The USA for instance presents “an undeniably tou-
gh market landscape” admits Berthomé. Not only do
“Americans typically resonate more with brand names
they are familiar with”, but the FDA regulations can be
awkward given that “most of our products come from
vegetal sources, so are sometimes classified as natural
products, which does not properly convey the efficacy
and safety image of our brands,” he recounts.
At the pioneering frontiers of dermo-cosmetics
JEAN-PAUL
BERTHOME
president,Laboratoires
Expanscience
ANNE-MARIE
NOIR
CEO, Laboratoires
Asepta
35. Healthcare & Life Sciences Review: France 35www.pharmaboardroom.com
COVER STORY
La French innovation!
failure to adapt lies at the heart of the issue. “We have
lost jobs in the French pharmaceutical industry because
our industry is failing to modernize. While the country
has over 200 manufacturing plants, many of them pro-
duce products without intellectual property, a distinct
weakness in the manufacturing situation of the coun-
try… Europe has recently developed 13 new molecules,
yet not one of them was manufactured in France. This is
a sign of things to come if we do not adapt,” he declares.
For Mr Barrois of Novartis this issue goes well beyond
France. “Worldwide, there is an excess of production
capacity, which is now being manifested in the sale and
sometimes closure of many plants” he notes.
Yet this has not impeded Novartis from investing
heavily in France. In June 2015, the Swiss company
announced an investment of EUR 800 million (USD
880 million) over the next three years, to be invested
in clinical research, industrial rehabilitation and a new
headquarters, with the ambition to cement its posi-
tion as the number one pharmaceutical company in
France in terms of revenues and market share. ALK’s
Denis Delval also underlines how France’s manufac-
turing bases retains the interest of multinationals. “In
2014, we inaugurated ALK´s production site in France
as our European hub for manufacturing all our sublin-
gual drops products. Such a move was one of the largest
product investments by ALK in recent years,” he disclos-
es. Revealingly though, he also admits that “such a deci-
sion would be harder to make under today’s climate”
and that, if the country is serious about retaining its
actors, within the infrastructure of a well-organized sys-
tem and established good practices.”
MAINTAINING A MANUFACTURING BASE
IN THE FACE OF DELOCALIZATION
Pharmaceutical production has long been a French
industrial flagship. Both local and international players
continue to invest in the country. Back in August 2013
the American Eli Lilly announced an investment of EUR
90 million (USD 119m) in its plant in Fergersheim, in
eastern France. Yet for such industrial investments to
continue will require a change in emphasis. As Christian
Lajoux, former president of the Fefis, the employers’
union for healthcare companies in France explains, a
AURÉLIEN
CHAUFOUR
managing director,
Anjac
PIERRE BANZET
president, Synerlab
Group
ALAIN SAINSOT
president,
Amatsigroup
36. 36 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
query such a statement. If you want to survive in France
you have to be willing to modernize. This means invest-
ing in innovation so as to provide technical added-val-
ue; investing in your people, equipment & machinery,
and R&D capabilities. There is a long-term future for
manufacturing in France just so long as we invest in
innovation and quality. We have a historical French
touch in the high quality of our people and machin-
ery that remains attractive to this day and this is some-
thing that as a country we can still further invest in.”
attractiveness, pharma companies investing heavily in
establishing a local manufacturing footprint will need
to be rewarded with “better visibility, better access to
the market and greater recognition of their industrial
presence.”
Aurélien Chaufour, managing director of Anjac, a
young CMO focused on innovation, paints a more opti-
mistic picture when it comes to the “made in France.”
“It is often said that this country can no longer be com-
petitive in the era of global manufacturing. I would
RANKING NUMBER 1 FOR RARE DISEASE:
“We actually view France as one of the best markets
in the world for orphan diseases,” exclaims Shire’s
general manager for France and the Benelux, Andrew
Obenshain. “If I were a patient with a rare disease, I
would want to be in France because this country is
a center of excellence globally,” he continues. “An
example of this is the treatment of Short Bowel Sy-
ndrome: there is a reference
center in France that sees more
patients than any other facility
in Europe and thus is gaining
more experience and expertise
than anywhere else. This level
of expertise instils great con-
fidence for the patient and in
turn, this could enable France
to be recognized as the number
one center of excellence for this
condition,” he adds.
BLAZING NEW TRAILS IN WOMEN´S HEALTHCARE:
“The health status of the population in France,” pu-
blished in February 2015 by DREES (Direction de la
recherche, des études, de l’évaluation et des statis-
tiques) made positive reading. French women have
a life expectancy of 85.4 years. Although the gap
between the sexes has been narrowing for 20 years,
women are still living longer than men: 79.2 years.
That puts the French substantially ahead of the EU
average, which is 76.1 years for men and 82.2 years
for women. One company that has long understood
the relevance of France when it comes to women´s
health is Gedeon Richter. In
2010, the Hungarian company
acquired the Swiss-based out-
fit, PregLem, a deal which Erik
Bogsch, group CEO, says repre-
sented a tremendous strategic
opportunity to strengthen Ge-
deon Richter’s core women’s
health business. Fast-forward a
few years and the French affi-
liate is now “starting to be a
real player in women’s health”
according to Ksenija Pavletic,
CEO of PregLem and President of Gedeon Richter
France. Ms Pavletic is in no doubt of the importance
of being present in this market. “The latest innova-
tions, know-how and inspiration are coming directly
from France, more than anywhere else. France has
always enjoyed one of the best healthcare systems
in terms of quality of care and access for women, so
if we strive to establish ourselves in the field of wo-
men’s health, we certainly need to maintain a strong
presence and attain success in the French market.”
One product in particular is a point of pride for the
Group: Esyma, a first-in-class treatment for uterine
fibroids, a condition that over 50 percent of wo-
men over the age of forty suffer from. “Besides
methods that relieved the symptoms, including
surgery, painkillers and some forms of contracepti-
ves, there was previously no medication developed
for this condition,” explains Ms Pavletic. Esyma was
approved by the EMA in February 2012, initially for
short-term use, and in May 2015 it was approved for
long-term use.
Local Industry Growth-spots
ANDREW
OBENSHAIN
general manager
France & Benelux,
Shire
KSENIJA
PAVLETIC
ARANICKI
president,Gedeon
RichterFranceand
CEOofPregLem
37. Healthcare & Life Sciences Review: France 37www.pharmaboardroom.com
COVER STORY
La French innovation!
THE ASCENT OF THE CMOs
Over the last few years, pharmaceutical companies
have increasingly outsourced “non-core” activities,
in particular manufacturing. As Lajoux explains,
“France is specialized in mature products and one of
the key issues for our country is to be a country pro-
ducing new drugs. After patents expire, production
sites close, and you need to identify contract manu-
facturers to continue with the production.” This out-
sourcing drive has provided significant growth oppor-
tunities for CMOs in France. The pharmaceutical
development world is changing. “Around four years
ago, large pharmaceutical companies began to allo-
cate more resources into outsourced research develop-
ment processes. From a manufacturing point of view,
drug discoveries are numerous and business dynam-
ics are evolving, primarily considering the influence
of large and mid-sized pharmaceutical companies,”
reveals Alain Sainsot, president of Amatsigroup, a
contract development and manufacturing organiza-
tion (CDMO), providing services throughout both
preclinical and clinical phases. The CDMO market
is very fragmented, where components of develop-
ment are divided among many small companies. “In
Northern Europe alone, there are approximately 500
small-scale companies dedicated to outsourced devel-
opment,” notes Mr Sainsot. Today Amatsigroup has
an annual turnover of EUR 33 million (USD 37.1
million) and is positioned as one of the leaders in
From a manufacturing point
of view, drug discoveries
are numerous and business
dynamics are evolving
ALAIN SAINSOT,
AMATSIGROUP
38. 38 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
favor of a CMO that we have a longstanding relation-
ship with, Fareva, will lead to increased investment in
France. We still see France as an attractive market to
manufacture products. The problem we were facing
in 2013 is that such plants, manufacturing primarily
small molecules and pills, were areas where internally
Pfizer´s volumes were decreasing. Viagra, which used
to be an important part of our business, was going off
patent, inevitably leading to a decrease in volumes. A
company such as Fareva can attract external volume
and offset the loss of Viagra, in a way that we would
not ourselves be capable of. 10 percent of the volume
of Pfizer products produced globally remain man-
ufactured in France”, a fact that serves to highlight
the sheer importance of France to Pfizer´s overall
manufacturing output. “This is a model that we will
look to adopt in a number of countries. Rather than
having our own plant, we will increasingly look to
collaborate with and co-opt local manufacturers”
contends Mr Ginestet. Moving forward, it appears
clear that France will act as a mirror for Pfizer´s
global strategy.
France. Such players are increas-
ingly seen as a strategic partner
for pharmaceutical companies. As
Pierre Banzet, President of Group
Synerlab, one of the top ten French
CMOs explains, “more and more,
Big Pharma companies acquire bio-
tech start-ups and their products
instead of relying solely on their
own R&D department. Then, they
subcontract production to CMOs
and other service providers. It is very possible that
Big Pharma in the future will have very lean manu-
facturing divisions, if at all, and that they will instead
focus solely on marketing and obtaining regulatory
approval”. One notable instance of this materialized
in 2013, when Pfizer announced the sale of its produc-
tion site in Amboise, central France, to French CMO
Fareva. But as Mr Ginestet of Pfizer France reveals
such a move did not imply any disengagement from
the county. On the contrary, “it may seem counter-
intuitive, but the very fact of divesting our plant in
PATRICE
CARAYON
CEO, Chiesi France
While France has long demonstrated creativity and innovation in abundance, when it comes to
b2b supplier interactions, the Anglo Saxon scientific and research community is often seen as
one step ahead. One American company, founded in Wisconsin, Promega, is now noticing a
decisive shift. “The culture in France is evolving. Previously, scientists were not particularly open
to building up relationships with suppliers, but today they understand that there are entities out
there able to assist them in publishing and increasing the visibility of their research that they
need to be interacting with,” notes Nicolas Bardonnet, the local affiliate’s general manager.
There has long been a notable difference when it comes to the use of social media: American
researchers have traditionally been much more open to such channels,” he explains. “Recently
though, more and more French scientists are beginning to appreciate the importance of being
visible on the web and how this can be a catalyst to increased interactions with suppliers, like
Promega, who are now being understood as important links in the innovation process.” With a strongly patented
portfolio of more than 3,000 products and applications encompassing the fields of genomics, protein analysis, cellular
analysis and genetic identity, Promega has risen to prominence as a global leader in enabling life scientists across
academic, industrial and government settings to answer fundamental questions about biological processes and as an
original equipment manufacturer (OEM) partner for the biotech, diagnostic and medical device segments.
Playing catch-up when it comes to supplier interactions
NICOLAS
BARDONNET
general manager,
Promega France
39. Healthcare & Life Sciences Review: France 39www.pharmaboardroom.com
COVER STORY
La French innovation!
Expert in early drug
development phases
Biologicals
Bioservices: In Life studies & Bioanalysis
Pharmaceutical Analysis Solutions
Formulation Development & Manufacturing
Clinical Trial Supply: Packaging & Logistics
A global Early CDMO
Highly qualified team of 280 people
300 clients from biotechs to Human & Animal health big players
sales@amatsigroup.com
www.amatsigroup.com
Parc de Génibrat
31470 Fontenilles - France
twitter.com/AmatsiGroup
linkedin.com/company/amatsi-group
one healthcare actor,” reveals
Philippe Luscan, vice president
for global industrial affairs, and
president of Sanofi France. “We
have 27,000 employees and over
40 sites, including 20 manu-
facturing centers out of a total
100 worldwide… From a trade
balance perspective Sanofi con-
tributes almost EUR 5.8 billion
(USD 6.35 billion) net to the
French economy, equal to the
entire food industry in France.”
Outside of the top five, France
has a network of innovative com-
panies operating across the drug
A MORE CONVENTIONAL
APPROACH
The majority of drug research,
development and production
in France is carried out by the
top five French players: Sanofi,
Servier, Ipsen, Pierre Fabre and
LFB. Collectively, they represent
more than 45 per cent of employ-
ment in the sector, almost 60
per cent of R&D investment
and more than half of employ-
ees engaged in research, accord-
ing to IMS Health data. “In
France, Sanofi is the number
value chain, in research, devel-
opment, production and mar-
keting. One such example is the
Italian outfit, Chiesi. As Patrice
Carayon, CEO of the French
affiliate, explains, “A key goal
is to establish a communication
strategy to ensure that Chiesi
is recognized as one of the few
international mid-size pharma-
ceutical companies in France to
conduct commercial activities
ensuring patients access to our
brands, alongside an R&D and
production footprint.” Globally
Chiesi has three manufactur-
ing centers: one in Parma, Italy,
alongside sites in Blois, France
and Santana De Parnaiba,
Brazil. Through a communica-
tion strategy Chiesi will look to
ensure that the fact that they
conduct industrial activities
in France “is accorded proper
weight when it comes to our
discussions with the author-
ities” insists Mr Carayon. Yet
the weakening of the pharma-
ceutical industry, especially in
terms of manufacturing, is not
a French issue, but a global one.
“There are simply too many fac-
tories and a gross overcapacity”,
insists Synerlab’s Banzet. “We
are witnessing an increasing
trend of ‘regionalization’ with-
in the pharmaceutical industry,
where companies decide to pro-
duce in Europe for European
markets, Asia for Asian markets,
and so on. The main driver that
40. 40 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
NASCENT BIOTECH
REVOLUTION?
“France has more or less the
same number of biotech compa-
nies compared to other advanced
west European economies. Yet
if you look at the capital and
turnover of French companies,
they are smaller than many oth-
er European markets. There is a
gap between invention and inno-
vation,” notes Mr Lamoureux.
The state is very much aware of
this and created the BPI (Banque
Publique d’Investissement) in
2013 guaranteeing access to
financing for small innovative bio-
tech companies. Yet “Germany
has done a better job in combin-
ing such companies in order to
diversify risk and create synergy,
pushed production to emerging
markets is wage levels, and those
are in the process of increasing”
adds Mr Banzet. Indeed, many
would argue that competitive-
ness is key if France is to remain
an attractive manufacturing envi-
ronment: “We have to deliver
quality, service and competitive
cost of goods. In most of the mar-
kets where we are active, there are
considerable pricing pressures,
and it is essential that our own
manufacturing arm is delivering
value to the chain. In France, over
the last five years, we have invest-
ed EUR 1.7 billion (USD 1.86 bil-
lion) in capital expenditure, of
which EUR 1.5 billion (USD 1.64
billion) was in the biotech field,
including vaccines. Our goal has
been to realign our network with
the company’s pipeline. Today, 85
percent of Sanofi´s R&D pipeline
is in biologic products,” reveals
Mr Luscan.
A GROUP COMMITTED
TO THERAPEUTIC
PROGRESS FOR
THE BENEFIT
OF PATIENTS
Servier – 50 rue Carnot
92284 Suresnes Cedex France
Telephone: +33(1) 55 72 60 00
www.servier.com
16HP5027IA
92%OF SERVIER DRUGS
ARE PRESCRIBED
OUTSIDE FRANCE
SERVIER IS AN INTERNATIONAL
PHARMACEUTICAL GROUP WITH
A PRESENCE
IN 148 COUNTRIES
AND OVER
21 000 EMPLOYEES
IN SALES REVENUES
ARE INVESTED IN RESEARCH
AND DEVELOPMENT
25% INDEPENDENCE AS AN ASSET:
100% OF PROFITS ARE USED FOR
THE DEVELOPMENT OF THE GROUP’S
OPERATIONS
SERVIER’S DEVELOPMENT RELIES ON THE CONSTANT SEARCH
FOR INNOVATION IN 5 AREAS OF EXCELLENCE:
NEUROPSYCHIATRY RHEUMATOLOGYCARDIOVASCULAR METABOLISMONCOLOGY
A GROUP COMMITTED
TO THERAPEUTIC
PROGRESS FOR
THE BENEFIT
OF PATIENTS
Servier – 50 rue Carnot
92284 Suresnes Cedex France
Telephone: +33(1) 55 72 60 00
www.servier.com
16HP5027IA
92%OF SERVIER DRUGS
ARE PRESCRIBED
OUTSIDE FRANCE
SERVIER IS AN INTERNATIONAL
PHARMACEUTICAL GROUP WITH
A PRESENCE
IN 148 COUNTRIES
AND OVER
21 000 EMPLOYEES
IN SALES REVENUES
ARE INVESTED IN RESEARCH
AND DEVELOPMENT
25% INDEPENDENCE AS AN ASSET:
100% OF PROFITS ARE USED FOR
THE DEVELOPMENT OF THE GROUP’S
OPERATIONS
SERVIER’S DEVELOPMENT RELIES ON THE CONSTANT SEARCH
FOR INNOVATION IN 5 AREAS OF EXCELLENCE:
NEUROPSYCHIATRY RHEUMATOLOGYCARDIOVASCULAR METABOLISMONCOLOGY
Today, 85 percent of Sanofi´s R&D
pipeline is in biologic products
PHILLIPE LUSCAN,
SANOFI
41. Healthcare & Life Sciences Review: France 41www.pharmaboardroom.com
COVER STORY
La French innovation!
DRUGS EXPENDITURE PER CAPITA (USD)
Source: LEEM.
USA
Canada
Japan
Ireland
G
reece
SwitzerlandG
erm
any
Belgium
ItalySweden
Spain
N
etherlands
France
1034
761 758 753
721
696
678
606
572
495 489
397
622
Founded in 1901,
Gedeon Richter Plc.
is an innovation-driven
specialty pharmaceutical
company. With a 1000-strong
R&D team and a portfolio
available worldwide, Richter
focuses on the therapeutic
areas of gynecology and
Central Nervous System.
WE RESEARCH.
WE INNOVATE.
WE CARE.
www.richter.hu
42. 42 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
Diagnostics: the bedrock of an efficient healthcare system
Jean-Luc Belingard is a man with over 35 years of experience within the healthcare industry, notably with MSD
and Hoffmann-La Roche, as well as serving as the CEO of Roche Diagnostics for over 10 years. From 2002 to
2010 he was chairman and CEO of the Ipsen Group. Since 2011, Mr Belingard has been leading the number
one microbiology diagnostic company in the world, bioMérieux, which enjoys about 40 percent global market
share and reached revenues of €1.965 billion in 2015.
JEAN-LUC
BELINGARD
Chairman,
bioMerieux
HCLS: How would you describe
the importance that the French
attach to diagnostics and what
role does bioMérieux, as a natio-
nal French champion, plays in this
picture?
J-LB: Deeply rooted in our genes is
the notion of adequate diagnostics,
something that is both technology
and medically driven. The fact that
the number one microbiology diag-
nostic company in the world, namely bioMérieux, is based
in France, underlines this point. Microbiology is a medical
discipline, and in this country medical doctors treat infec-
tious diseases with that dual perspective. As a company
with almost ten thousand employees, our greatest asset is
our medical culture, grounded in an excellent understan-
ding of bacteria. When we talk about an expertise in diag-
nostics, we are not referring to sophisticated technologies,
which we possess, but a deeply rooted understanding of
infectious diseases.
Someone once said to me that the most expensive di-
sease is the one that does not have a medical treatment.
This is certainly the case. Therapeutic solutions are deeply
rooted in adequate diagnostics. A medical doctor without
the proper diagnostics tools, the bedrock of an efficient
healthcare system, is blind. The convergence of clinical and
technology-based diagnostics is key. bioMérieux acts as a
key link in the medical value chain.
HCLS: In an environment of cost-cutting measures,
where healthcare expenditures are increasingly unsustai-
nable, how do you see the future of diagnostics?
J-LB: Diagnostics has a great future ahead of it. It accounts
for only three percent of total healthcare expenditures to-
day; and yet is the best way to effectively treat a medical
condition, from a therapeutic standpoint, is proper diag-
nostics. It is also the best way to save on medical expendi-
ture. From a technology point of view, it is also a nascent
sector. The promise of future technologies is considerable,
greatly increasing the clinician’s understanding of any me-
dical condition.
HCLS: How would you sum up the key strengths of
both the French healthcare system and of bioMérieux?
J-LB: The US remains the hub of innovation in the world,
and this goes well beyond the healthcare space. By
not having proximity to such a reality implies you are
missing something. This explains our focus on the US
market, which comprises more than 40 percent of the
global diagnostic market. Historically the US represen-
ted around 25 percent of bioMérieux´s revenues. We ac-
quired BioFire in 2014 for two main reasons: technology
and geographic balance. Today over 30 percent of our
revenues are derived from the US. BioFire provides us
with three key strengths: firstly a condensed timeframe
to attaining results, secondly multiplexing and thirdly
a syndromic approach. A syndromic approach is based
on analyzing a set of symptoms and testing for multiple
potential causes of disease. Many infectious diseases
have a common clinical presentation caused by a variety
of pathogens. BioFire technology allows physicians to
apply a syndromic approach to infectious disease tes-
ting using a single reagent. The syndromic approach
helps to eliminate guesswork and to identify different
pathogens faster than before.
HCLS: How would you sum up the key strengths of
both the French healthcare system and of bioMérieux?
J-LB: France enjoys both a high-quality healthca-
re system and a deeply rooted medical culture. In-
deed, many medical disciplines have been invented
by French leaders, from neurology to paediatrics and
surgery. France should be proud of the fact that, in
my opinion, its healthcare system is the best in the
world. The medical community in this country has a
unique profile, a blend of both clinical and technolo-
gical experience. Doctors in France are clinicians; our
country has a longstanding history in clinical therapy.
Beyond this tradition, however, France has also adop-
ted the most sophisticated technologies. This unique
combination produces an end result that is extremely
effective from a medical standpoint. Unfortunately,
the country has yet to fully embrace its healthcare in-
dustry, a core element of its healthcare independen-
ce and economic well-being. There are very few truly
global healthcare industries in the world; in this regards
France stands alongside countries such as the US, Japan
and the UK. When it comes to bioMérieux, a key stren-
gth is our entrepreneurial spirit. We are a global and
multicultural company, but one that retains its strong
French roots.
43. Healthcare & Life Sciences Review: France 43www.pharmaboardroom.com
COVER STORY
La French innovation!
INVENTING HEALTH
BEYOND BORDERS
théra•Photo:N.Bouchut
www.biomerieux.com
P ION EER I NG DIAGNOSTICS
As public health challenges know no borders, bioMérieux is
committed worldwide to the fight against infectious diseases.
A world leader in the field of in vitro diagnostics for over 50 years,
bioMérieux provides diagnostic solutions (reagents, instruments,
software) which determine the source of disease and contamination
to improve patient health and ensure consumer safety.
44. 44 Healthcare & Life Sciences Review: France www.pharmaboardroom.com
COVER STORY
La French innovation!
who do not conduct phase I-II tri-
als in France because the process is
such that you can finish in other
countries before you can even start
in France. Speed is critical for bio-
techs because they need to show
concrete results in order to get
additional funding for the next
period,” notes Denis Comet from
France’s Association for CROs:
AFCRO. Yet for Patrick Winkler,
French clinical trial manager of the
Cincinnati based CRO Medpace, “it is France´s high
capacity for innovation, due in large part to the coun-
try´s biotech sector, that ensures it remains a key mar-
ket when it comes to expanding throughout Europe.”
Indeed, the establishment of partnerships with bio-
tech companies in France is a priority for many phar-
maceutical giants. One biotech company in particular
has caught the attention of the international media,
Cellectis. In 2015 Pfizer and Servier agreed to co-de-
velop and co-commercialize UCART19, an allogeneic
CAR-T cell therapy for hematological malignancies, in
a three-way deal. André Choulika, chairman and CEO
of Cellectis, has a bold vision based on gene edition. “It
started 15 years ago and will remain one of the main
drivers not only in healthcare, but in life sciences. In
the future we are going to eat gene editing, wear gene
editing, and cure ourselves with gene editing! The 21st
century will be the century of gene editing and Cellectis
will be one of the leaders of this revolution.”
which also helps them obtain more funding,” insists
Mr Sarkozy. The attractiveness of France for interna-
tional clinical research has also been declining, a com-
mon phenomenon in Western countries; which are
losing market share in clinical research to developing
nations. “Currently, there are many biotech companies
www.asepta.com
4 KEY BRANDS
Since their creation in 1943, LABORATOIRES ASEPTA have stood out for constant
innovation in the development of exclusive active ingredients and high quality products.
Thanks to its unique expertise, the Monaco-based company
is the unquestionnable partner of pharmacists and podiatrists.
LITTLE STORY OF A BIG LABORATORY
In 1943, Paul LACROIX, Henri MAS and Henri ADAM came up with
a unique product:a soothing foot cream that was adopted by the Croupiers !
Patent & Products
Wether they are dry, overheated or
even clammy, AKILEÏNE® meets
all the needs of your feet.
Thanks to the high quality formulas
and frequent innovation, AKILEÏNE®
has become the reference brand
for foot care and is ranked leader
in French pharmacies !
Launched in 1977, COUP D’ECLAT®
was originally a cult product:
the famous Ampoule Lifting,
known for its immediate tensing effect.
Today it belongs to a large range of
complementary treatments.
Since its creation in 1970, ECRINAL®
has been devoted to the beauty
and health of skin appendages
(nails, eyelashes and hair).
With its unbeatable effectiveness,
it is now the leading nail care brand
in French pharmacies.
The first VITA CITRAL®
hand cream appeared in 1952.
Always at the forefront for protective
and soothing hand treatments,
the brand has extended its expertise
to lip protection and body pampering.
PATRICK
WINKLER
Clinical Trial
manager, Medpace
France
It is France´s high capacity for innovation, due in large
part to the country’s biotech sector, that ensures
it remains a key market when it comes to expanding
throughout Europe
PATRICK WINKLER,
MEDPACE