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TOMORROW’S
VACCINES
TODAY.
METALLSTRASSE 4, 6300 ZUG, SWITZERLAND
OFFICE PHONE: +41 (41) 7253230
OFFICE FAX: +41 (41) 7253239
www.amvac.eu
[email protected]
AMVAC:
TOMORROW’S
VACCINES TODAY
Since its inception in 2005, AmVac has developed into a serious player in the vaccine sector
combining powerful vaccine development platforms with one of the most innovative and
advanced pipelines in this business.
AmVac has:
• exclusively acquired three unique technology platforms (Gynevac, Sendai
Vector, MALP2) for the development of innovative vaccines.
• built an advanced portfolio of six vaccine candidates, each of which is
uniquely positioned in commercially attractive growth markets.
•
built a highly effective drug development organization with access to
a dedicated manufacturing facility for the lead compound and a strong
network of experts and service partners in the relevant disciplines of drug
development and approval.
• a well-managed IP portfolio with a strong IP position.
• straightforward development plans with defined milestones.
AmVac AG can be considered as a model case for the successful and efficient transfer of
basic research results into the industrial development of a completely novel type of safe
vaccine for a broad range of applications.
Continued investment in vaccines is important to promote
the public health contribution of these life-saving products
and also represents an excellent opportunity to maximize
return on investment
The projections and predictions contained in this document relate to future facts. Such projections and predictions are
subject to risks which cannot be foreseen and which are beyond the control of AmVac. Among other things, AmVac
can offer no assurance that it will develop effective vaccines or therapeutics, obtain regulatory approval for its products,
market or sell products based on its technologies, obtain or maintain patent protection for its technologies and product
candidates or that technologies used by AmVac will not be subject to third party intellectual property rights. AmVac is,
therefore, not in a position to make any representation as to the accuracy of economic projections and forward-looking
statements or their respective impact on the financial situation of AmVac or the value of its shares, and is not under
any obligation to update such information. In addition, information regarding market and industry statistics contained
in this presentation is based on information available to AmVac and which AmVac believes is accurate. It is generally
based on academic and other publications that are not produced for the purposes of securities offerings or economic
analysis. AmVac has not independently verified this information, nor has it reviewed or included data from all sources,
and it cannot give any assurance regarding the accuracy of the data it has included. Prospective investors should not
rely on such data and information and AmVac cannot assume any responsibility for the accuracy of the market information
and industry data contained herein. This presentation including all complementary documents are confidential and only
for your personal information and analysis. You are not allowed to distribute them to third parties.
Vaccines have emerged as one of the most profitable business segments in the healthcare
industry. The global vaccines industry was valued at $24 billion in 2009, and is expected
to reach $52 billion in 2016 at a Compounded Annual Growth Rate (CAGR) of 11,5% and is
one of the fastest growing industries worldwide.
1
VACCINE DEVELOPMENT
Gynevac Platform
Product
VACCINE DEVELOPMENT IS A LONG AND COMPLEX PROCESS.
Vaccine development consists of three parts: basic research, a preclinical and a clinical phase.
Clinical trials involve three steps: Phase I trials, usually on healthy volunteers, determine safety and
dosing; Phase II trials are used to get an initial reading of efficacy and further explore safety in small
numbers of patients; Phase III trials are large, pivotal trials to determine safety and efficacy in sufficiently
large numbers of patients.
•Produce an
immune
response?
•Protect after
viral
challenge?
Goals
BASIC RESEARCH TO FIND
A LEAD CANDIDATE
PRECLINICAL
•Safe?
•Immune
response?
•Best dose?
•Safe?
•How much of
an immune
response?
PHASE I
PHASE II
20-50
People
100-300
People
Status Target market Advantages
AMV100
Gynecological infections
mainly bacterial vaginosis
(BV) and trichomonads:
treatment and prevention
of recurrence
Phase III for EU
Women
AMV100
Secondary complications due to
BV: Prevention of preterm
birth/HPV/HIV/etc.
Preparation of
phase III
Women
No significant side effects.
Infection rate recurrence only for 5% of the
patients against 80% with competitive products.
Full recovery bacterial flora
No risk for antibiotics resistance
AMV110
Chronic prostatitis/BPH:
treatment
Preparation of
phase III
Men over 50 and
potential watchful
waiting patients
No siginificant side effects.
Long term effect and highly effective (positive
results for 91% patients in a pilot study)
Superb safety levels • Sendai Vector Platform: a generation of prophylactic and therapeutic vaccines
that combine ultimate safety with excellent efficacy.
•Does it
work?
PHASE III
The platform enables the generation of a new class of semi-live vaccines. The Sendai Vector system uniquely
combines the efficacy of live vaccines with the ultimate safety of inactivated vaccines. Unique opportunity for
effective protection of children, elderly or patients with impaired immune system who are not eligible for traditional
treatment methods.
The technology has been exclusively licensed in from Max Planck Innovation in Munich, Germany. It offers almost
infinite opportunities as the Sendai Vector system can be combined with almost any antigen of choice to target a
broad range of diseases.
Sendai Vector Platform
Product
Participants
Indication
2,000-10,000
People
Indication
Status Target market Advantages
AMV602
Respiratory syncytial virus (RSV): Preparation of
prophylaxe
Phase I
High risk population segments (e.g.
children, elderly)
Highly safe and efficient
Potential market pioneer
AMV611
Human parainfluenza virus type 3 Preclinical
(PIV3) and RSV: prophylaxis
Children
Highly safe and efficient
Potential market pioneer
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 YEAR
OVER THE PAST 8 YEARS AMVAC HAS BUILT UP A BROAD
PLATFORM AND PRODUCT PORTFOLIO.
AmVac has established three powerful product development platforms:
• Gynevac Platform: development of therapeutic vaccines against the most
frequent urogenital diseases.
The platform offers a new exceptionally safe and effective treatment modality to a broad range
of urogenital conditions. It is based on a perfect blend of inactivated lactobacillus strains with the
unique capability to stimulate the immune system against invading pathogens.
The platform has already led to the successful launch of a marketed product in Hungary with
overall experience from over 200,000 patients.
• MALP2 Platform: a generation of adjuvants that can be combined with almost
any vaccine to improve its efficacy and reduce its cost.
Adjuvants are substances that are mixed with vaccines in order to enhance immune reaction of the body against
the antigen (vaccine). An adjuvant increases vaccine efficacy and efficiency leading to significant cost savings
and helping to prevent supply shortfalls, e.g. in flu seasons. With this adjuvant, Amvac meets a strong demand
from vaccine developers around the world for new and better adjuvants. MALP2 is easy to produce, particularly
effective and a versatile chemical compound. It is exclusively licensed in from the Helmholtz Center for Infection
Research in Braunschweig, Germany.
MALP2 Platform
Product
Indication
Status Target market Advantages
AMV411
Pandemic flu
Preclinical
High risk population Improved efficiency with decreased antigen
segments (e.g.
Potential, vaccine rate can be increased
children, elderly)
Needle free application
AMV401
Seasonal flu
Preclinical
High risk population
segments (e.g.
children, elderly)
Under analysis
3
AMV110
MARKET POTENTIAL FOR AMVAC’S
MOST ADVANCED PRODUCTS
AMV110 is a lactobacillus-based vaccine candidate designed for the treatment of chronic prostatitis/
benign prostate hyperplasia (BPH). The product successfully completed a clinical phase II trial in
Hungary involving 100 patients with chronic prostatitis/benign prostate hyperplasia (BPH). Results
were highly encouraging: 91% of patients reported decreased symptoms and increased quality of
life. Remarkably, no undesired side-effects such as decreased libido or hypotension occurred.
Benign prostate hyperplasia (BPH) is manifested by tissue hyperplasia, which is caused by a loss of
regulatory control of prostate cells. BPH affects ~50 million men aged over 50, and more than 33
million of these men suffer from moderate to severe Symptoms. BPH is currently treated with either
alpha-blockers and/or 5-alpha reductase inhibitors, each with significant side effects. Approximately
20% of patients receiving treatment suffer from side effects that lead patients to discontinue therapy.
Chronic prostatitis is an extremely painful condition, which afflicts over 50% of adult men during
their lifetime. Men suffering from prostatitis often experience intense pelvic pain with frequent,
urgent and painful urination and sexual dysfunction. The underlying cause of the disease is not well
understood. Current therapies are deemed inadequate. Urologists have identified chronic prostatitis
as an area of high unmet need, resulting in a significant opportunity for an effective new treatment.
The Benign Prostatic Hyperplasia Market, 2004-2014: Key Statistics
United States Prevalent population Market ($MM) 2004 2014
18.9 m 22.7m
974.9 1,650.9
Europe Prevalent population Market ($MM) When men have the symptoms
of BPH or enlarged prostate such
as frequent urination, they are
interrupting their life constantly,
- whether they are at a football
game, on the golf course or out
fishing - because they have to
use the bathroom.
AmVac can help them with
product candidate AMV110, so
these men can get back to their
lives with no interruption.
Almost infinite market opportunities
2004 2014
28.5 m 32.2m
991.4 1,296.9
Japan 2004 2014
Prevalent population 8.4 m 9.2m
Market ($MM) 645.4 768.8
Note: Estimates for Europe cover France, Germany, Italy, Spain and United Kingdom
Source: Decision Resources, Inc.
5
AMV100 – THERAPEUTIC LACTOBACILLUS VACCINE
FOR GYNECOLOGICAL INDICATIONS
AMV602 - RSV
The product gained regulatory approval in Hungary in 2006
meeting EU requirements for the treatment of acute, subacute
and chronic gynecological inflammations caused by bacteria
and trichomonads. It has since been applied successfully to
over 200,000 patients, with long-term positive clinical outcome
and not a single case of severe side-effects. AmVac is currently
preparing dossiers for market authorization in the EU, US and
other countries, based on the Hungarian approval. Additional
observatory studies show efficacy for further indications. An EMA
compatible phase III trial with AMV 100, related to pre-treatment
of patients undergoing in vitro fertilization, is on-going.
The global market for topical BV treatments alone is estimated
at approximately US$350M. AmVac’s modeling suggests, the
addressable global market for prevention of recurrence of BV is
potentially in excess of $1 billion, due to the long-term usage
associated with such a product.
AMV602 is AmVac’s first vaccine based on the Sendai Vector platform. This platform allows the
development of different vaccines that are safe and very efficacious at the same time. RSV is
the most important cause of viral lower respiratory tract illness in infants and children worldwide,
being responsible for a large number of hospitalizations due to pneumonia or bronchiolitis every
year. In the USA approx. 25% of hospitalized pneumonia cases in children and approx. 70% of
hospitalized bronchiolitis cases in children are attributable to RSV infections. In the USA alone it is
estimated that RSV infections are responsible for approx. 126,000 hospitalizations of infants per year.
The global RSV disease burden is estimated at 64 million cases and approx. 160,000 deaths
every year (source: WHO, Acute Respiratory Infections (Update February 2009)).
The size of the target population for prophylactic RSV vaccination is about 81.3 million people
in the USA, about 87.1 million people in the 5 major European markets (Germany, France, Italy,
Spain, U.K.), and about 38.1 million people in Japan (Source: Datamonitor Stakeholder Opinions:
Respiratory Syncytial Virus (RSV) Infection. 2006). For details see the table below
Elderly
Incidence:
94 million pa in the five major EU countries, US and Japan
Secondary infection/
complication
Risk increase
HIV* 25% thereof
candidiasis
25% thereof
trichomoniasis
Gynecological complications
Pelvic inflammatory disease* Post abortion infection* 50% thereof Post hysterectomy infection* Cervicitis bacterial
vaginosis
Obstetrical complications
Amniotic fluid infection* Chorioamnionitis* Postpartum endometritis ** Preterm birth ** 2-4 fold
* Proven relation to bacterial vaginosis
** Strong epidemiological relation to bacterial vaginosis
Risks:
Vaginal infections are door-openers to serious secondary
infections such as HIV and are the main cause of preterm birth.
Secondary infections and complications open additional potential
markets for AmVac:
Overall, approximately 10%-15% of all births are pre-term births.
In approximately 70% of all cases of pre-term birth vaginal
infections have been diagnosed. Pre-term birth is a major economic,
emotional and social burden leading to high lifetime costs. The
direct costs during initial hospitalization in Germany alone are
estimated to be 1.6 billion Euros per year.
Premature
infants
Total
37’196
22’929
20’639
527
81’291
Japan
25’534
6’463
6’055
96
38’148
Germany
16’018
4’546
3’542
68
24’174
9’998
3’329
3’740
73
17’104
11’450
3’236
2’632
51
17’370
Spain
7’170
2’205
2’023
39
11’437
U.K.
9’564
4’031
3’280
65
16’940
116’930
46’739
41’911
919
206’464
Italy
Total
2-7 fold
2-7 fold
3-16 fold
2-7 fold
Children
< 4 years
of age USA
France
9 fold
2 fold
3-4 fold
in 50%
Adults with
cardiopulmonary
disease
Size of the target population for a prophylactic RSV vaccine in thousands
The target population in only the seven major markets is 206 million people. At
a vaccination rate of 25% this could result in annual peak sales for a RSV vaccine
of CHF 1.85 Billion.
7
AmVac has a balanced portfolio of proprietary technologies and innovative vaccine
candidates, with one candidate already approved for specific markets.
AmVac received the following
prestigious grants in recognition
of its on-going vaccine research
efforts:
AmVac is well backed by 1st tier private investors, who have so far provided total funding of CHF
28.7M in various financing rounds during 2005-2011.
AmVac is now ready to initiate the next development steps that will trigger an upsurge in
commercial value:
• Obtaining market approval for its lead products in EU core markets (and subsequent partnering)
• Start of EMA compatible phase III trial with AMV110 (chronic prostatitis)
• Start of EMA compatible phase III trial with AMV 100 related to pre-treatment of patients undergoing in vitro fertilization
• Execution of clinical phase I/IIA in humans for the RSV vaccine
• Preclinical test of MALP2 combined with an influenza vaccine and subsequent clinical phase I
Research grant for AmVac
Research GmbH
Start of the approval
process for Gynevac
Foundation of AmVac Kft.
Start building-up a dedicated,
modern, state-of-the-art
production facility
for Gynevac
Preclinical proof-of-concept
for first Sendai Vector-based
product candidate
Renewal of exclusive licence
agreement for the MALP2
platform
With these proceeds, AmVac expects to reach a crucial value inflection point by attaining significant
product development milestones anticipated up from 2014.
Foundation of
AmVac AG
Frost & Sullivan’s
Enabling-Technologyof-the-Year-Award
Foundation of AmVac
Research GmbH
Acquisition of
Gynevac rights
Renowned experts join AmVac’s
board: Prof. Dr. Carlos Guzmann, Foudation of FranVax Srl
Prof. Dr. Wolfgang Neubert,
EPO approval of MALP2
Prof. Dr. Reinhard Glück
related patents
Acquisition Sendai Vector rights
Acquisition of MALP2 rights
Regulatory approval
for the laboratories
of AmVac Research GmbH
(class S1 and S2)
Foundress AmVac AG, entrepreneur; a long experience in start-up and
development companies (medtech, biotech and IT industry). Current role at
AmVac: overall responsible & general management.
Thomas Schletter
Chief Operations Officer, Dipl. Ing. Chemie, MBA, langjährige Erfahrung in
Pharma-Rx & Biopharma-Industrie für General & Commercial/M&S/Market
Access Management inkl. Impfstoffe bei u.a. bei Wyeth/Pfizer, Daiichi-Sankyo,
Sanofi Pasteur MSD
Dr. George Kavkasidze
Head of Marketing and Business Development; Medical doctor, with academic
degree of PhD. Almost 20 years operational experience in multicultural
environment, including 16 years in marketing and sale of biotechnology
products (Serono and Merck-Serono). Developer of several marketing and
promotional projects, contributing to double digit sales growth.
Ferenc Zimonyi
Former CEO of Omninvest (No. 1 Hungarian flu vaccine producer). Under his
direction a H5N1 pandemic mock-up vaccine was developed, which ensures
safe and effective protection with a single vaccination, and with low antigen
content. During the 2009 flu pandemic, the company’s swine-flu vaccine
was among the very first ones which were granted marketing authorization
in Europe and was used for mass-vaccination of the Hungarian population.
Prof. Dr. Reinhard Glück
International vaccine expert, former president of Swiss Biotech Association,
currently CSO at Zydus Cadila
Prof. Dr. Carlos A. Guzmán
Head Vaccinology, Helmholtz Centre for Infectious Diseases, Braunschweig/
Germany
Prof. Dr. Wolfgang J. Neubert
Head Research Molecular Virology, Max Planck Institute of Biochemistry,
Martinsried/Germany
Dr. med. Ladislav Prikler
Direction Uroviva, Centre of Urology in Bulach and Clinic Hirslanden, Switzerland
AMVAC IS WELL PREPARED TO TAKE THE NEXT KEY STEPS
AmVac Research GmbH*, Martinsried / Munich, Germany
• 550 m2 R&D facility
• BSL1 & BSL2 laboratories
• Research and development of Sendai and
MALP platforms and related projects
AmVac AG, Zug, Switzerland (headquaters)
• General management, finance, project
coordination and administration
*100% subsidiary of AmVac AG
AmVac Kft*, Budapest, Hungary
• Coordination of production, clinical development and
regulatory approval of Gynevac
• Supporting the approval and management of Gynevac
production facility in Hungary, which is operated by
Vakcina Kft and financed by AmVac AG
FranVax Srl*, Catania, Italy
• 240 m2 R&D facility
• BSL1 standard laboratories, animal facilities
• Immunological research and preclinical services for Sendai, MALP and Gynevac
EU – Leishmania vaccine
(consortium)
EU – Universal Flu vaccine
(consortium)
Bayerischen Forschungsstiftung –
Sendai/RSV
Recruitment of three experts
with long-standing experience in
the production, quality assurance
and licensing of vaccines.
Recruitment of an internationally
experienced marketing and business
development manager to lead
commercialization activities.
Melinda-Kinga Kárpáti
CEO
EPO approval of Sendai
Vector related patents
AmVac has an established infrastructure and organisation while maintaining
lean cost structure
Continued progress with
the development
of the Gynevac platform.
9
EXIT STRATEGIES
1. Generating Revenues
Product
3. IPO
Indication
Partnering status Commercial strategy Market opportunity
At the moment there is no urge for AmVac to go to the stock market, but it has to be considered
in the future if there is a possibility on the market.
Such a potential IPO could take place at the SIX Swiss Exchange in Zurich (SIX).
AMV100 for bacterial vaginosis (BV)
Treatment
Prevention of recurrence
Internal
Internal
Sales income to BPh Sales income to BPh
US $ 300-350 Million
Estimated >US $ 1 Billion
AMV100 for secondary infections/
complications due to BV
Prevention of preterm birth/ Internal
HPV/HIV/etc.
Sales income to BPh
US $ 3-6 Billion
AMV110 for chronic prostatitis/BPH
Treatment
Sales income to BPh
> US $ 10 Billion
Internal
Even with conservative projected market penetration rates AmVac should be
capable to create revenues of 400 Mio CHF in 2019.
The advantages of having a listing at the SIX are:
• Zurich is a strong international financial centre with global leading banks.
• Investment banks are locally positioned with well established research and a strong
placement power.
• Every IPO gains high attention.
2. Out-License Deals
4. Trade Sale
Sendai Vector, RSV vaccine
Another alternative is a Trade Sale. Many experts estimate that the next 24 months are the best
time for a Trade Sale with Big Pharma.
Product
Indication
Partnering status Commercial strategy Market opportunity
AMV602 for respiratory syncytial Prophylaxis Internal
virus (RSV)
License out after Phase I/Iia
US $ 1,9 Billion
Further vaccines on the base of the
Prophylaxis
Internal
Sendai Vector plattform
License out after Phase I/Iia
US $ > 10 Billion
If the vaccine is safe and has an effect in humans it will represent a potential multi-billion $ market.
Therefore there is a high possibility that Big Pharma will pay for a license, at least CHF 30,- million
to CHF 50,- million in upfront cash, plus CHF 400,- million to CHF 500,- million in milestone payments
based on future success in development.
A trade sale can offer successful private biotech companies a higher return on investment in
a shorter time than an IPO. Therefore trade sales have become an established alternative for the
biotech sector.
Trade sales have been growing, in terms of both deal frequency and the size of private biotech
acquisitions.
EXCELLENT OPPORTUNITY TO MAXIMIZE RETURN ON INVESTMENT
But if AmVac can strike one of these straightforward licensing deals, investors who take the risk
of backing AmVac will only have to wait two to three years, and could then be rewarded with a
significant return on their investment from the upfront cash payment alone. Beyond that, the
investors still have room for greater upside returns if the drug continues to progress.
11
This fits in with the idea that if you have chronic
inflammation someplace, you’re at greater risk for
negative health outcomes, in this case preterm birth.
Raymond White
President & Chief Executive Officer
United Validation & Compliance Services,
Inc Watseka, IL
This is consistent with previous epidemiologic and genetic
research that has suggested that prostate cancer may result
from chronic inflammation, perhaps as a response to infection.
Eric A. Klein
MD, a thought leader in the biology and management
of prostate cancer, has been appointed chairman
of the Glickman Urological & Kidney Institute
If we can use one-fifth of the vaccine along with an adjuvant,
then the vaccine will go five times farther allowing that many
more people to be vaccinated.
Kathryn Edwards
M.D., professor of Pediatrics, vice chair of Pediatric Research
The rapid development and enormous potential of biotechnology
and life science have greatly contributed to the fight
against diseases and safeguard of health by mankind.
Hu Xiaodi
Ambassador of the Republic of China