The biopharma
sectorInnovation andgrowth for Italy

This publication owes much to the work of the recently-departed Eugenio Aringhieri who
left us far too early in life.
As President of Farmindustria’s Biotechnology Group, Eugenio was a visionary andhigh-profile manager, constantly at the cutting edge of innovation, full of enthusiasm,
proactive and ever in search of a solution to problems. His loss is felt not only by the
Association but also by the entire biopharma world.
This publication is affectionately dedicated to his memory.

Table of Contents
01

Towards a new role for biopharmaceuticals.........04

02

Innovation, the engine of growth......................08

03

Cooperating to innovate..................................1204

How can we attract resources for innovation?......18

05

Companies in the biopharma sector.................26

Towards a new rolefor biopharmaceuticals

Massimo Scaccabarozzi
President of Farmindustria

We celebrated some important anniversaries in 2018:
the first forty years of the National Health Service,a resource shared by the whole country, and thejudgement handed down by the Constitutional Court
in 1978 that, by allowing pharmaceutical patenting,created the conditions for the biopharma sector togrow and flourish in Italy.
For the past forty years, Farmindustria’s principal
mission has been to cultivate this development.
Furthermore, as a corollary to the majortransformations taken place over this lapse of time,
we are now witnessing even more radical changes
engendered by an unprecedented acceleration ininnovative processes.
Every phase in mankind’s evolution has been marked
by technological breakthroughs impacting at anever faster pace. This exciting race for knowledge
proceeds by leaps and bounds. Thus mankind
needed 150 thousand years between the discovery
and deployment of fire but only 66 years elapsed
between the first human flight (40 metres) andthe first flight to moon. In no more than 14 years
the costs of sequencing the human genome have

4 | The biopharma sector Innovation and growth for Italy

fallen from one hundred million to one thousand
dollars, while in another fundamental area, namely
information technology, we see the processing powerof a microchip doubling every 18 months.
Today we are clearly living in one of these technologicalleaps. Moreover, the life sciences are an example ofthose fields where the boundaries between different
disciplines and sectors are rapidly breaking down:
genomics, big data, robotics, gene therapy, artificial
intelligence, and nanotechnologies interact andcross-fertilise to produce extraordinary results.
Personalised medicine and digital pharmaceuticals
are now a fact of life and have completely changed
our approach to many diseases, together withtherapeutic improvements that only a short time ago
would have been unimaginable. Pharmaceutical R&D
is experiencing a period of great vivacity with 15,000
new potential medicinal products in the pipeline.
This is the context in which Italy has become theleading pharmaceutical manufacturer in the European
Union thanks to a highly skilled workforce, the vitalityof the companies operating in the territory and thequality of hi tech upstream sectors.

Towards a new role for biopharmaceuticals

Moreover, the country’s R&D expertise is second
to none. Our pharmaceutical companies, whose
investments in the last 5 years were higher thanthe European average, now operate at the centreof an ecosystem. In this environment, research is
no longer confined to corporate boundaries but
increasingly performed through partnerships with
universities, SMEs, start-ups, no-profit bodies andclinical centres, where now almost 20% of the studies
conducted in Europe are carried out. This outcome isdue to the many excellences within the territory thathave generated value for patients, as well as for the
NHS and the scientific system as a whole.
Italy, therefore, can compete internationally in life
sciences and biopharmaceuticals and it can attract
an ever greater share of the financial resources
invested every year in R&D throughout the world.
However, our competitors are numerous andinvestments are made wherever the most efficientsystems are to be found.

we are calling for a new governance that will allow
companies to rise to the challenges posed by the
rapidly transforming manufacturing environment inwhich they operate.
A system is at its most efficient when financing issufficient, resources are used efficiently, the latest
mechanisms for programming expenditure arein place, access to new pharmaceutical products
is rapid and uniform throughout the territory
but also, and above all, when the protection of
intellectual property and patents is respected inorder to guarantee the right to the most appropriate
treatment for all citizens.

The biopharma industry is ready to invest even morein Italy, but our country, for its own part, must satisfy
the criteria of efficiency requested. For this reason,

The biopharma sector Innovation and growth for Italy | 5

Towards a new role for biopharmaceuticals

Biopharma, an opportunity for the country
The biopharma sector, an engine of innovation
With €

720 million invested in R&D in 2017, biopharmaceuticals

represent one of the sectors that is staking its future on innovation. By targetingbiopharmaceuticals, we provide access to new therapies, improve the quality ofpatients’ lives and reduce the social costs associated with pathologies.

A significant worldwide role

10 billion the biopharma companies in Italy represent about
5% of the sector worldwide and 32% of the pharmaceuticalindustry within the national territory.
With total sales ofAn excellence Made in Italy
Researchers with renowned expertise, technologically advanced centres of
excellence, and an entrepreneurial community comprising

200 companies

and 4,000 research employees: the biopharma sector, an industry
Made in Italy, is a source of pride for the country.

The need for networking
Strategic planning, dedicated legislative measures and better public-private
cooperation – specifically, cooperation between the institutions, universities,
companies, physicians and patient associations – is essential for biopharma’s growth.

6 | The biopharma sector Innovation and growth for Italy

Towards a new role for biopharmaceuticals

The Italian biopharma sector of 2017 in figures

200 companies

Large, medium-sized, small and micro companies operate in thebiopharma sector, each with an ongoing commitment to innovation.

4,000 R&D employees

Professional personnel and researchers of recognised excellence, whose
numbers have been growing at the rate of 1.8% per year since 2015.

720 million euro invested in R&D

Investments by biopharma companies in R&D are growing 2% for year
and represent ongoing innovation benefitting not only patients but ourcountry as a whole.

10 billion euro in sales

Biopharma confirms its importance for the health sector.

5% share of the world biopharma market
Italy boasts a significant worldwide sales performance.

8.5% growth in biopharmaceuticals

The growth of the biopharma sector is higher than that recorded forthe world as a whole.

Data referring to companies that perform production activities in Italy in one or more of the following areas: R&D on biotech medicinal products and/or vaccines for human use, R&D on correlated services (drug delivery, or the development of technologies for transporting medicinal products to a specific site; drug discovery, or the provision of services correlated to the achievementof the final product or other correlated services), the production of biotech medicinal products and/or vaccines, the marketing of biotech medicinal products and/or vaccines, and the provisionof correlated services (drug delivery, drug discovery).

The biopharma sector Innovation and growth for Italy | 7

Innovation,
the engine of growthInnovation always generates greater value for our country

In an era in which technology, speed and flexibility are the principle factors in determining a country’s competitiveness,innovation and its dissemination should be understood as a means to generate value for an economic system.
Innovation in Italy continues to grow, creating ever new development opportunities.

4,300

Italian patents in Europe 2017,+4.3% more than the preceding year.

Italy ranks 5th in Europe1.

R&D spending as a percentage of
GNP is forecast to grow from

1.4% to 1.5%
in 2020

which, however, remains below theaverage European target of 3%2.

+18%

more patent applications forpharmaceuticals Made in Italy
in 2017, compared to theEuropean average of 8.1%1.
1. EPO (European patent office) statistics
2. Eurostat
3. Farmindustria, Pharmaceutical Indicators 2018
4. EY Analysis

8 | The biopharma sector Innovation and growth for Italy+16%

growth in pharmaceutical exports
from Italy in 20173.

Innovation, the engine of growth

Biopharmaceuticals: at the forefront of innovation in Italy

3 times the average

1.5€ billion

in R&D investments by thepharmaceutical industry, +22%
in 5 years, and growing fasterthan the rest of Europe (+16%)3.

The biopharma sector:
a strategic asset forthe country

11%of all corporate R&D investments
are made by pharmaceuticalcompanies; accounting for 6.5%of all Italian R&D3.

32%

of all upstream production in thepharmaceutical industry in 2017
was generated by biopharma,
which has been growing at a rateof about 8% per year since 20154.

amount of investment in innovationfor employee, with a 3.2% increasein R&D employees since 20163.

72%

of all investment in production andresearch by the pharmaceuticalindustry is in the biopharma sector3.

The biopharma sector Innovation and growth for Italy | 9

Innovation, the engine of growthInnovation and expertise: the opinion of a panel of companies¹
representative of the biopharma sector
What does innovation in the pharmaceutical sector mean?
Introducing new therapies
Making new therapies available that can change people’s lives, especially in those therapeutic areas
characterised by unsatisfied health needs such as oncological pathologies or rare diseases.

Improving the life of millions of patients
Innovations in existing therapies to improve the quality of patients’ lives and increase life expectancy.

Optimising processes with new technologies
Deploying new digital technologies, big data and robotics for basic research, pre-clinical and clinical
trials, therapy production as well as for communicating with physicians and patients.

Contributing towards the sustainable development of the National Health System
More effective innovative therapies can reduce hospitalisation times and costs and thus generatesavings for the NHS and benefits for patients.

1. Companies involved: AbbVie, Amgen, Chiesi Farmaceutici, Dompé Farmaceutici, Menarini Group, Merck Serono, MSD Italia, Novartis Farma, Pfizer Italia, Roche,
Sanofi10 | The biopharma sector Innovation and growth for Italy

Innovation, the engine of growth

What skills are needed to excel in the biopharma sector?
Multi-disciplinary training

In the biopharma sector, technical skills go hand-in-hand with an understanding of corporate processes.
Biopharma companies offer training schemes for newly graduated employees so they can acquire experiencein several different areas such as research, production, market access, communication and regulatory affairs.

Work and study courses

Theoretical training and practical applications are necessary to prepare young people entering
employment for the first time. Training courses must be encouraged that, for example, include internships
in companies, scholarships and joint degrees.

International experience

The joint pursuit of research, business and innovation is now a global concept. Italy competes with foreigncountries to attract resources and develop talents while our researchers cooperate on international
research projects. Language skills and exchange programmes between international research centres
are now essential features of the industry.

University - company partnerships

Research is not an end in itself but a means to develop new therapies. R&D projects conducted jointly
between the academic and business worlds are ever more widespread. Managerial and soft skills, within
multi-disciplinary teams, are necessary in order to dialogue profitably with industry and investors.

New technologies

Innovative biotechnologies, big data and robotics have radically changed the reference context. A
knowledge of new technologies, their operation and possible applications, is essential for success inbiopharmaceuticals.

Flexibility and willingness to learn“Learning to learn”: universities must teach students to keep themselves updated and conversant witha continually changing world that requires new skills and ever more flexible professional figures.
With 4,000 R&D employees, growing at an average rate of 2% for year,
biopharma is one of the sectors that offers the best job opportunities in Italy.

The biopharma sector Innovation and growth for Italy | 11

Cooperating
to innovate
The role played by universities, companies and institutions
The innovation process calls for close cooperation between the universities, as promoters of research, andcompanies as facilitators of the development and uptake of new biotech therapies. The institutions also play a keyrole in creating an ecosystem favourable to innovation through measures aimed at reducing red tape, encouraging
investments and promoting cooperation.

Universities

Companies

The institutions

Teaching new skills for a changing
world• Providing students withskills appropriate for future
employment• Investing in research• Encouraging researchersand safeguarding intellectual
property• Acquiring the skills needed todevelop technological transfer
processes.

Innovating to compete as well as
to improve patients’ lives• Investing in basic and clinicalresearch in association with
universities, research centres
and hospitals• Making new therapies available• Supporting programmes for
efficient training• Offering opportunities for the
professional development ofresearchers in Italy.

Encouraging an innovation
orientated ecosystem• Developing a system of clear
rules that remain fixed overtime to stimulate investments ininnovation• Streamlining bureaucratic
processes for public-private
cooperation• Broadening access to innovative
therapies• Safeguarding and valorisingintellectual property.

12 | The biopharma sector Innovation and growth for ItalyCooperating to innovate

Outstanding examples of public-private partnerships
Dompé and ophthalmic research
A successful Italian public-private partnership
From the cooperation between Dompé and the Universities
of Chieti and L’Aquila, the Centre of Excellence inOphthalmology and the Abruzzo Region, the first everbiotech therapy was developed to treat neurotrophic
keratitis, a rare disease of the cornea that can lead toblindness. Altogether, 1,000 sq. m of laboratory spaceand over 70 researchers have been earmarked topreclinical and clinical trials for the development andmanufacture of new therapies. The culture of innovation
is promoted by teaching provided by Dompé personnel in
its partners’ facilities. 10 scholarships are also awarded
every year to pre-and post-graduate students.

The Merck Serono establishment in Bari
The South of Italy as an engine of pharmaceuticalinnovation of international renown
Over time Merck Serono has developed what is now a
cutting-edge production facility for biotech medicinal
products. Today it is the leading exporter in the cityand province of Bari (31% of all exports from the area)
and contributes 4% to Italian pharmaceutical exports
overall. This is an automated «fill & finish» facility thatguarantees the entire productive process commencing
from the preparation of a biotech medicinal product to its
despatch to around 150 countries throughout the world. It
represents a successful case of public-private cooperation.
Currently, the site has about 300 employees, and overthe past 5 years, received € 85 million in investments, ofwhich about 20% co-financed by the Puglia Region.

Istituto Mediterraneo per i Trapianti

San Raffaele Biomedical Science Park

Biotech and high-level specialisation, Sicily’s
recipe for excellence

The cluster as a means to promote technologicaldevelopment and transfer

ISMETT (Istituto Mediterraneo per i Trapianti e Terapie
ad Alta Specializzazione) [the Mediterranean Institute forAdvanced Specialisation in Transplants and Therapy] isa centre of excellence for transplants. The institute, theoutcome of a partnership between the Sicilian Region andthe University of Pittsburgh Medical Center, is an example
of innovative and efficient healthcare management. In
June 2017 the Ri.MED Foundation became one of ISMETT’s
partners, in order to promote biotech projects andresearch. Within its 12,000 sq. m, the institute possesses
4 operating theatres, clinical, microbiology and anatomicalpathology laboratories, a radiological department andmulti-specialist outpatient clinics.

The San Raffaele Biomedical Science Park is one of thelargest biomedical scientific parks in Europe. Financed
autonomously, it sets out to perform integrated researchand development, training and cooperation programmeswith companies. It assists researchers and companies
with its research and development activities, laboratory
management, access to technological donations andconsultancy on intellectual property and technologicaltransfer. It also includes a Biotech Research Department(DIBIT) that comprises 12,000 sq. m of laboratory space,entirely dedicated to basic research.

The biopharma sector Innovation and growth for Italy | 13

Cooperating to innovate

Technological transfer to sustain innovation inbiopharmaceuticals and its reference models
Technological transfer is the process whereby biopharma
research results are transformed into new therapies ormedicinal products

1. NETVAL 2018 report
2. Full Time Equivalent

Support for
research

alu

ati

The
technologicaltransfer process
Sa

les

on

g
tin ngkeensir
Ma Lic&Technological transfer: the bridge between research and innovation

Research andInvention
Generating new ideas

Dis

Ev

PatentTechnological transfer acts as bridge between the academic world, whose
objective is to guarantee the dissemination of research, and industry whose
aim is to transform the results of scientific research into new therapies forpatients. There are currently 2251 officers in the technological transfer
offices of Italian universities, with an average of 4.2 FTE2 for each office,which is still a limited number compared to the European average of 8.5
FTE2 per office. The dissemination and efficiency of technology transfer
processes should be seen as priorities if innovation in the biopharma
sector is to be sustained. Universities and research bodies must endow
themselves with appropriate skills to evaluate the potentiality of new
discoveries, as also to safeguard intellectual property and develop
agreements with companies.

ery

v
co

Innovation

Dissemination

Transforming new
ideas into products or processes

Disseminating innovation
in society

14 | The biopharma sector Innovation and growth for ItalyCooperating to innovate

Technology Transfer Company
The Israeli innovation model

Israel has adopted the Technology Transfer Company (TTC) model as an alternative to the traditional Americanmodel of the Technology Transfer Office (TTO), which consists in setting up a dedicated office for technologicaltransfer inside a university. Instead, TTCs are independent (founded by one or more universities and possiblywith private partners) and have the mission of sustaining R&D by making projects financially autonomous,
assisting industry to access inventions and financing, and safeguarding not only the independence and the public
utility of the research but also intellectual property rights. Unlike the TTO, TTCs enjoy greater independence
and autonomy of movement as they are, in actual fact, spin-offs created by the universities.
A TTC sets itself the task of:• evaluating an innovative project and its potential• reaching agreements with industry to finance research projects• protecting the intellectual property of a university and its researchers through patents• supporting the dissemination of an invention through commercial agreements and licensing.
It would appear that the TTC is a successful model for innovation: the Weizmann Institute of Science’s TTC,YEDA, at Rehovot, Israel, comprising 12 partners, has, between 2013 and 2015, helped WIS’s scientists
register over 260 patents, obtain financing for 90 R&D projects and present over 4,500 developed research
projects to companies1.
The activities of the TTCs in Israel have benefited the entire country.
• Israel is a leading country in terms of innovation with R&D expenditure accounting for almost 4.4% of GNP;
twice the OECD average2• Israel attracts more start-ups and investments than any other country in the world.

1. YEDA statistics
2. OECD: The Organisation for Economic Cooperation and Development

The biopharma sector Innovation and growth for Italy | 15

Cooperating to innovate

Reinforcing partnerships between the academic world andthe biopharma industry
Maria Cristina Messa

Rector of the Bicocca University of Milan and President and CEO of the University for Innovation (U4I)

The biopharma sector is undergoing continual
innovation. How can universities contributetowards such innovation?
First of all, biotech courses must be brought upto-date so that students can keep abreast of thischanging world and be suitably qualified for a job when
they graduate. Thus, the curricula of newly graduatedstudents must include a thorough knowledge of the
new technologies, digital tools and, more in general,the processes for developing and marketing biotech
medicinal products. With this objective in mind the
Bicocca University of Milan is participating in a roundtable with regional and national institutions.
Moreover, as cooperation with companies is of evergreater importance for the universities, PhD courses
play a key role. More and more scholarships arefinanced by companies and 70% of students whocomplete a PhD course find employment in companies
in this sector. The Bicocca University of Milan has, incooperation with biopharma companies, introduced
PhD courses specific to the industry in order to train
professional figures to develop autonomous researchskills and prepare themselves for work in this sector.

16 | The biopharma sector Innovation and growth for Italy

What incentives exist to encourage cooperation
between universities and biopharma companies?
The principal limits to cooperation between
universities and companies are cultural andbureaucratic.
It is necessary, in the first place, to disseminate aculture of cooperation as a means for developing
joint research programmes aimed at stimulating
innovative therapies. Bureaucratic procedures must
be streamlined and harmonised, and guidelines
defined that clearly regulate relations between
universities and industry.
In conclusion, the universities must acquire thetechnical, legal and managerial skills necessary to
manage technological transfer processes.

New didactic programmes
and greater cooperation withcompanies are the key tothe success of tomorrow’s
universities.

Cooperating to innovate

U4I – University4Innovation

Outstanding cooperation between universities
U4I, the first Italian project for the valorisation of inter-university research, is the product of cooperation
between the Bicocca University and the Universities of Milan, Bergamo and Pavia.
U4I sets out to attract important international investors, valorise its unique portfolio of patents, stimulate thegrowth of spin-offs and create and disseminate a culture of innovation.
U4I’s objective is to:• identify and evaluate the most promising research projects• finance R&D costs, especially through public-private collaboration• facilitate the protection of the three universities’ intellectual property• cooperate with the industry to exploit innovation• promote joint innovation between the three universities in order to develop new discoveries.
U4I represents the first example of technological transfer in Italy aimed at increasing patenting capacity andentrepreneurship among researchers.
U4I’s success in figures: 41 departments involved, over 2,000 researchers, more than 100 patent families.

There can be no progress
without innovation: we must
transform ideas into projects
and projects into progress.

The biopharma sector Innovation and growth for Italy | 17

How can we attract resources
for innovation?
The key elements for sustaining innovation
The biopharma sector in Italy has the chance to play a leading role in the international arena. However, humanresources must continue to be developed, intellectual property safeguarded, bureaucratic simplification guaranteed
and long-term stability of government measures ensured.

Human resources

Targeting instruction
in biopharmaceuticals
in order to attract anddevelop talents
Research and intellectual property

Stimulating technologicaltransfer processes tomaintain competitivenessIn a highly innovative and continually changing sector, cross-disciplinary
skills are essential. Universities must update their didactic courses, andcompanies must cooperate with them to provide on-site training and create
the skills needed for tomorrow’s jobs. Mapping out an educational path forbiotechnologies represents an opportunity for young people’s future.

Disseminating technological transfer processes will enable Italy to maintaina competitive international role in biopharmaceuticals. However, there arethree areas where action needs to be taken:• streamlining bureaucratic procedures for efficient cooperation between
universities and industry• endowing universities with technological transfer skills, also through thecreation of special-purpose structures (e.g. U4I the Bicocca University)• providing incentives for scientific production and valorising theintellectual property of researchers.

18 | The biopharma sector Innovation and growth for Italy

How can we attract resources for innovation?

Financial resources

Attract investments in R&D
in order to continue to grow

Governance and the regulatory
framework

Guarantee uniform accessto innovative therapies forthe well-being of all patients

Italy competes with other countries in the world to attract the financial
resources held by companies and investors. This activity presupposes threerequisites:• a culture that can capitalise on the support provided by investors
specialised in R&D processes• the presence of specialised investors in the biopharma sector• a plan for fixed and long-term measures to boost investments.
Enlarging and speeding up access to new therapies is a priority as it will
improve patients’ lives and provide hope for the treatment of still incurable
pathologies. A dialogue is needed between institutions and companies for:• an administration that is fully aware of the country’s needs• the streamlining of bureaucratic procedures• reimbursement policies that take account not only of a therapy’s cost
but also of the benefits expected and the social and hospitalisation costs
avoided.

The biopharma sector Innovation and growth for Italy | 19

How can we attract resources for innovation?

How to make the Italian biopharma sector attractive
to specialised investors?
Federica Draghi (FD)Business Development Director

What factors attract investments in the biopharma
sector?
(FD) Success in this sector entails the following
components: a high level of innovation for single
projects but also for the research ecosystem as awhole; the human factor, understood as the skills
and experience of the actors involved in developing
a project; and access to specialised capital able tosustain the various stages of the long path toward
the production of a medicinal product such as publicgrants, business angels, venture capital, strategic
investors and a receptive public market.
(CG) The presence of specialised investors and,
therefore, of persons able to understand and relate
to scientific, clinical, regulatory, and pharmacoeconomic matters is fundamental if we are to attract
investments. Given that today venture capital
investments in Italy only amount to about € 200
million compared to € 2 billion in France, there is still
ample room for growth. 4 venture-capital funds are
now operating in Italy, and each year they invest in
about 3 - 4 innovative companies.
What biopharma segments are the most attractive
for investors?
(FD) Currently rare diseases attract considerable
attention as also do highly complex therapeutic areas
representing still largely unsatisfied medical needs
such as oncology and neurology.

20 | The biopharma sector Innovation and growth for Italy

Claudio Giuliano (CG)
Innogest’s Founder(CG) A specialisation in key therapeutic areas isimportant. In Italy, we find major excellences in thefield of cardiology, metabolic pathologies, immunooncology and neurology.
What legislative measures are sustaining
biopharma investments in Italy and abroad?
(FD) In recent years the institutions, (e.g. the Ministryof Economic Development) have become more willingto discuss our needs and adopted measures in favourof investments in innovation, although these arescheduled to be phased out by the end of 2020. The
hope remains that our dialogue with the institutions
can continue. We are now finally competitive at theEuropean level but we need stability if we are toremain so.
(CG) France is an excellent example of a country thatover the last 20 years has shown itself able to createa culture in favour of innovation and investments inresearch thanks to a policy centred upon venture
capital. In Italy, it is necessary to introduce measures
aimed at increasing both the number and the scope ofventure capital operators by deploying not only public
capital - in the form of mutual funds – but also tax
measures to facilitate investments in such funds bymajor institutional investors, such as banks, insurancecompanies and pension funds. Italy must find the will
and the courage to sustain a large-scale system ofinnovation rather than continuing with small-scale,albeit appreciable, incremental measures.

How can we attract resources for innovation?

Tax measures to sustain innovation in Italy and abroad
Italy has introduced various instruments in favour of innovation. However, the continuity of such interventions mustbe guaranteed in the long term if investments in our country are to be encouraged.

Italy

Tax credit

Patent box

Up to 50% of incremental
R&D costs

Up to 50% of income from
copyright, patents ortrademarks is excluded fromthe assessment of tax liability

Up to 25% for asset
acquisitions related toinnovative development in theSouth of Italy

Super and hyper
depreciation
140% of the acquisition costof new assets
250% for the purchase of fixed
assets related to Industry 4.0

Other
Reverse brain-drain: 4 year
exemption on 90% of thetaxable income of professors
and researchers; 5-year tax
exemption of 50% of taxable
income of foreign workers
seconded to Italy
Detractions for investments
start-ups and innovative SMEs
(30%)

FranceUp to 30% of incremental R&D
costs for a maximum of € 100
million
5% on excess spending

Spain

Up to 25% of incremental
R&D costs
Up to 42% of the amountexceeding average R&D
spending recorded in the 2
preceding years

15% preferential tax rateon national and European
patents (the invention must be
patentable in France)

Accelerated depreciation

Favourable tax regime forcapital gains from investments
in innovative start-ups (from
50% to 85% according to theduration of the investments)

60% abatement of the taxable
income of companies holding
patents

Accelerated depreciation

40% reduction in social
security/pension contributions
for R&D personnel

Germany

No measures provided

No measures provided

No measures provided

Direct 75% subsidy of R&D
investment costs

UK

Up to 12% for incremental R&D
costs

10% preferential tax rate forincome derived from patents

No measures provided

Tax relief for SMEs increased to230% of qualifying R&D costs

Source: EY analysis

The biopharma sector Innovation and growth for Italy | 21

How can we attract resources for innovation?

Non-European countries targeting biopharmaceuticals
The biotech industry in China¹
Biotech lies at the heart of China’s growth strategy and, hence, is one of the objectives included in the country’s
2016-2020 strategic plan. By 2020 income from biotech is forecast to account for more than 4% of GNP.
Also by 2020 and with investments for $ 1.45 billion, China plans to build between 10 and 20 biomedical parks,
which will be in addition to the already 100 scientific parks existing in the country.
China today: innovation and biotech• Over the last 5 years China has ranked second in the world for publications and patent applications• Over $ 100 billion in public investments to finance an ambitious strategic plan forecast for the life-sciences
sector• With its «Thousand Talents» programme, over 7,000 scientists returned to China, of whom 1,400 in thebiopharma sector• $ 45 billion in Chinese venture capital and private equity has been raised for biopharma investments in only
30 months• The universities cooperate with inventors to develop start-ups and spin-offs (technological transfer).

1. Source: EY analysis

22 | The biopharma sector Innovation and growth for Italy

How can we attract resources for innovation?

The priority voucher mechanism as an incentive for innovative
start-ups in the USA
The priority voucher mechanism was introduced by the Food and Drug Administration (FDA) in 2007.
Companies that develop a product designed to treat orphan or rare paediatric pathologies (the criteria are laid
down by the FDA), receive a voucher giving them a privileged right to submit a dossier to the FDA.
A company awarded a voucher can either sell it (e.g. to other pharmaceutical companies) to finance research oruse it to submit its invention or the results of other studies to the FDA, thus avoiding long delays and reducing
evaluation time from 10 to 6 months.

In recent years Italy has brought its own system ofinnovation measures into line with those of other countries.
Ongoing investment in this system is of primary concern
if we are to profit from its benefits and keep pace withemerging countries.

The biopharma sector Innovation and growth for Italy | 23

Innovation is the ability to seechange as an opportunity:
focusing upon the biopharma
sector constitutes the key tosuccess for the entire country.

24 | The biopharma sector Innovation and growth for Italy

The biopharma sector Innovation and growth for Italy | 25

Companies
in the biopharma sector
AAA - Advanced Accelerator
Application S.r.l.

Biogen Italia S.r.l.

Chemi S.p.A.

EspiKem S.r.l.

Biogenera S.p.A.

Chiesi Farmaceutici S.p.A.

Etna Biotech S.r.l.

AbbVie S.r.l.

Bioindustria L.I.M. S.p.A.

Chorisis S.r.l.

Eudendron S.r.l.

Accelera S.r.l.

Bioindustry Park Silvano Fumero
S.p.A.

Chrono Benessere S.r.l.

EUROSPITAL S.p.A.

ACS Dobfar S.p.A.

Clonit S.r.l.

Euticals S.p.A.

Actelion Pharmaceuticals Italia S.r.l.

Bio-Ker S.r.l.

Congenia S.r.l.

Explora Biotech S.r.l.

Adienne S.r.l.

BioMarin Europe Ltd.

Corion Biotech S.r.l.

Ferring S.p.A.

Alexion Pharma Italy S.r.l.

Biomedical Research S.r.l.

Cosma S.p.A.

Fin-Ceramica Faenza S.p.A.

Alfa INTES Industria Terapeutica
Splendore S.r.l.

Biomedical Tissues S.a.s.

CPC Biotech S.r.l.

Flamma S.p.A.

Biopharma S.r.l.

Alfasigma S.p.A.

CRS4 Bioinformatics S.r.l.

FlowMetric Europe S.r.l.

BioPox S.r.l.

ALK Abello’ S.p.A.

CryoLab S.r.l.

Franvax S.r.l.

BioRep S.r.l.

Allergan S.p.A.

CSL Behring S.p.A.

Galileo Research S.r.l.

Biorigen S.r.l.

Altergon Italia S.r.l.

Cutech S.r.l.

Genenta Science S.r.l.

Biosistema S.r.l.

Amgen S.r.l.

DAC S.r.l.

Genomnia S.r.l.

Biosphere S.r.l.

Anallergo S.r.l.

Daiichi-Sankyo Italia S.p.A.

Genovax S.r.l.

BiosYnth S.r.l.

Aptalis Pharma S.r.l.

DI.V.A.L. S.r.l.

Gentium S.p.A.

BiotechSol S.r.l.

Aptuit S.r.l.

DIATHEVA S.r.l.

GeXNano S.r.l.

Biotest Italia S.r.l.

Ardis S.r.l.

Dompé Farmaceutici S.p.A.

Gilead Sciences S.r.l.

Biouniversa S.r.l.

Areta International S.r.l.

DSM CAPUA S.p.A.

GlaxoSmithKline Vaccines

Boehringer Ingelheim Italia S.p.A.

AstraZeneca S.p.A.

EG S.p.A. – Laboratori Eurogenerici

Gnosis S.p.A.

Bristol-Myers Squibb S.r.l.

AXXAM S.p.A.

Elab S.r.l.

Grifols Italia S.p.A.

BSP Pharmaceuticals S.r.l.

Bayer S.p.A.

Eli Lilly Italia S.p.A.

HMGBiotech S.r.l.

byFlow S.r.l.

BiCT S.r.l.

Epi-C S.r.l.

Holostem Terapie Avanzate S.r.l.

C4T S.C.a r.l.

Bio3 Research S.r.l.

EPINOVA Biotech S.r.l.

Immagina BioTechnology S.r.l.

Biocell Center S.p.A.

Ceinge - Biotecnologie Avanzate
S.C.a r.l.

Epitech Group S.p.A.

In4tech S.r.l.

Biofer S.p.A.

Celgene S.r.l.

EryDel S.p.A.

IOM Ricerca S.r.l.

26 | The biopharma sector Innovation and growth for Italy

Companies in the biopharma sector

Ipsen S.p.A.

Molmed S.p.A.

Pierre Fabre Pharma S.r.l.

SiTec Consulting S.r.l.

IRBM Science Park S.p.A.

Molteni Farmaceutici S.p.A.

PinCell S.r.l.

Stallergenes Italia S.r.l.

Istituto Biochimico Italiano
Giovanni Lorenzini S.p.A.

MSD Italia S.r.l.

Primm S.r.l.

Stemgen S.p.A.

Mundipharma Pharmaceuticals
S.r.l.

Probiotical S.p.A.
Procos S.p.A.

Swedish Orphan Biovitrum - SOBI
S.r.l.

Istituto di Ricerche Biomediche
Antoine Marxer S.p.A.

Naicons S.r.l.

Proge Farm S.r.l.

Synbiotec S.r.l.

Janssen-Cilag S.p.A.

NatiMab Therapeutics S.r.l.

Prolabin & Tefam S.r.l.

Synchimia S.r.l.

Kedrion S.p.A.

Naxospharma S.r.l.

Proteotech S.r.l.

Syntech S.r.l.

Kither Biotech S.r.l.

NeED Pharmaceuticals S.r.l.

ProXentia S.r.l.

Takeda Italia S.p.A.

Ktedogen S.r.l.

Nerviano Medical Scienses S.r.l.

PTC Therapeutics S.r.l.

Takis S.r.l.

Lachifarma S.r.l.

NeuHeart S.r.l.

Ranbaxy Italia S.p.A.

Technogenetics S.r.l.

LB Research S.r.l.

NeuroVisual Science Technology
S.r.l.

RareSplice S.r.l.

Tes Pharma S.r.l.

Lipinutragen S.r.l.

Neuro-Zone S.r.l.

ReiThera S.r.l.

Tesaro Bio Italy S.r.l.

Lofarma S.p.A.

Newron Pharmaceuticals S.p.A.

ReMembrane S.r.l.

Teva Italia S.r.l.

Lundbeck Italia S.p.A.

NGB Genetics S.r.l.

Research Toxicology Centre S.p.A.

TIB Molbiol S.r.l.

Medestea Research & Production
S.p.A.

RigeneranD S.r.l.

Tissue and Organ Replacements
S.r.l.

MediaPharma S.r.l.

Novartis Farma S.p.A.

Menarini Group

Novo Nordisk Farmaceutici S.p.A.

Merck Serono S.p.A.

NuvoVec S.r.l.

Merz Pharma Italia S.r.l.

Olon S.p.A.

Microbion S.r.l.

Oncoxx Biotech S.r.l.

Microbiotec S.r.l.

Pfizer Italia S.r.l.

Micron Research Service S.r.l.

Pfizer S.r.l.

Miltenyi Biotec S.r.l.

PharmaGo S.r.l.

Mipharm S.p.A.

Philogen S.p.A.

Nicox Research Institute S.r.l.

Roche S.p.A.
Rottapharm Biotech S.r.l.
S.A.F.AN. Bioinformatics S.a.s.
Sandoz S.p.A.

TTFactor S.r.l.
TYDOCK PHARMA S.r.l.
UB-Care S.r.l.
UFPeptides S.r.l.

Sanofi S.p.A.
Servier Italia S.p.A.
Setlance S.r.l.

ViroStatics S.r.l.
Vismederi S.r.l.
WetWare Concepts S.r.l.

Shire Italia S.p.A.
Sirius biotech S.r.l.

Xeptagen S.p.A.
Zambon S.p.A.

The biopharma sector Innovation and growth for Italy | 27

Credits
Farmindustria:
Maria Grazia Chimenti
Maurizio AgostiniMaria Adelaide Bottaro
Agostino Carloni
Riccardo Pareschi
Carlo Riccini

EY:
Marco Mazzucchelli
Marco Daviddi
Fabrizio de Simone
Alessandro Fazio
Giorgio Palma
Marina Golinelli
Cristina Bressanelli

With the contribution of:
Massimo Scaccabarozzi
Maria Cristina Messa
Federica Draghi
Claudio Giuliano

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