Advanced Accelerator Applications Luca Maciocco (R&D project manager, tech. coordinator) on behalf of

Advanced Accelerator Applications
First Bern Cyclotron Symposium, 6-7 June 2011
Luca Maciocco (R&D project manager,
tech. coordinator)
on behalf of
Stefano Buono (President & CEO)
AAA: Highlights
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Privately held, international molecular diagnostics and
therapeutics company founded in 2002 as a spin-off of CERN
laboratory, headquartered in Saint Genis Pouilly, France
Focus on molecular imaging and personalized medicines to treat
serious conditions including oncology, CNS, cardiovascular and
infectious diseases
Specialist in production and commercialization of Positron
Emission Tomography (PET) and Single Photon Emission
Computed Tomography (SPECT) products
Growing international presence
• 10 production and R&D facilities
• 150 employees in six countries (France, Italy, Switzerland,
Spain, U.S., Canada)
• 33 R&D specialists
2009 revenues up 96% to €23.8m – 2006-2009 CAGR of 60%
(estimated revenues in 2010 based on AAA accounting: €27.8M)
2009 EBITDA 5.84m – 2006-2009 CAGR of 82%
(estimated EBITDA 2010 based on AAA accounting: €6.3M)
Robust cash generation funds innovative research
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Gluscan® - AAA’s leading PET product
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High barriers to entry
– 10 hour shelf life
– Technical production challenges
• Multiple pharmaceutical productions
per day
• Timing
• Logistics
• Know-how for fast problem-solving
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AAA has unique industrial approach to
FDG production
– AAA laboratories have the most
reliable pharmaceutical production in
PET
Doses available for injection vs. time
after production of FDG
• Best -in-class technology
• Highest pharmaceutical standards
– All laboratories combine production
and R&D activities
– Laboratories built for modularity and
scalability, to meet future market
demand
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Sites status updated
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AAA facilities
Laboratories:
– 6 production/R&D sites operational
– 2 production/R&D sites waiting for GMP
approval
– 2 pure R&D sites (Arronax facility in
Nantes, France; St. Louis, Missouri,
U.S.)
– New projects to be launched (Marseille,
Paris already started)
All AAA sites designed to produce
Gluscan ®, PET investigational medical
products (for human injection) and new
PET commercial tracers
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Commercial partnerships for FDG production
and distribution (first site: Geneva University
Hospital, Switzerland)
GLUSCAN® site training and licensing (first
sites: NTP Radioisotopes, South Africa and
Cyclopharma, Casablanca, Morocco)
AAA is the fastest growing player in the
European PET market
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Annual PET Revenue Growth AAA *
€25,000
75% CAGR in the period 2004-2010
€20,000
€15,000
€10,000
€5,000
€0
2004
2005
2006
2007
2008
2009
2010
* Revenue figures exclude SPECT business, i.e. Gipharma
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The broadest PET product portfolio
Product
Use
Status
Gluscan®
[18F]FDG PET tracer that assesses
glucose metabolism
Available in all European
markets
IASOflu®
Sodium Fluoride 18 PET tracer indicated as
a bone imaging agent
Available in Italy and France
- seeking approval in other
markets
IASOdopa®
Aromatic amino acid that accumulates
rapidly in target tissues- used in neurology
and oncology.
Available in France - seeking
approval in other markets
IASOcholine®
Imaging agent used for oncologic
diagnostic procedures where there is
enhanced choline influx in specific organs
or tissues
Available in France - seeking
approval in other markets
Cardiogen®
Myocardial perfusion PET imaging agent
Phase III
All PET products currently on the market worldwide are non-patented
PET market will experience a significant growth with new patented products arriving
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Research products
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CARDIOGEN® - myocardial perfusion PET
imaging agent
[18F]-FMC - choline uptake PET marker
[18F]-FMISO - hypoxia PET marker
[18F]-FLT - tumor proliferation PET marker
[18F]-FET - amino acid PET tracer
[18F]-FDDNP - amyloid plaque PET marker
[18F]-MPPF - PET imaging of serotonin-1A (5HT1A) receptors
[18F]-FALLYPRIDE - PET imaging of
dopamine D2/3 receptors
[99mTc]-ANNEXIN V-128 - apoptosis and
necrosis SPECT marker
[177Lu]-DOTA-OCTREOTATE (LUTATE) treatment of metastatic gastro-enteropancreatic neuroendocrine tumors (GEPNETs)
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• Ephoran – a company founded by AAA, Bracco and BiPCa (Bioindustry Park of
Canavese) to provide integrated multi-imaging solutions for pre-clinical and clinical
research
• Operates in close collaboration with CEIP (Center of Excellence for Preclinical Imaging),
a public imaging platform in BiPCa (AAA’s Ivrea site).
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CEIP platform (operated by Ephoran and AAA
on request) includes 1100 m2 of laboratory,
animal testing facility and imaging equipment at
AAA’s Ivrea site
Imaging equipment included animal PET,
SPECT, MRI, optical imaging, High Frequency
US, NMR, Electron Microscopy - being
extended to CT and Echo 3D
Animal models: oncology, cardiovascular,
neurology, inflammation, others on customer
request
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AAA moving into SPECT
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SPECT - the largest segment of molecular nuclear medicine (approx. 70%), but
growing more slowly than PET due to poor innovation
In 2009 AAA acquired Gipharma - an Italian pharmaceutical contract manufacturer of
injectable and freeze dried products, specialized in SPECT radiopharmaceuticals
Current products used to perform nuclear medicine diagnostic procedures in lung
scintigraphy; lymphoscintigraphy; sentinel node detection in breast cancer surgery;
and hepatobiliary system imaging
First commercial products:
– MIBITEC : generic version of the widest used SPECT cardiac imaging agent
– Leukokit : medical device that improves safety of peripheral leukocyte labelling procedure in
molecular nuclear medicine
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Fostering innovation with SPECT
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AAA is investing US$6m in Atreus (Canada)
to allow it to move its leading compound
Annexin V-128 for early diagnosis of
rheumatoid arthritis into phase II
Annexin V licensed by Stanford University
Demonstrated ability to image cellular
apoptosis and necrosis conditions
associated with diseases including
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Crohn’s
Alzheimer’s
Myocarditis
Cardiac transplant rejection
Acute myocardial infarction
Unstable atherosclerotic carotid artery
disease
Tc-99m labelled Annexin used to evaluate
response to treatment for lymphoma and
lung cancer
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AAA’s therapeutic business
• Molecular Nuclear Therapy using β- - emitting
radioisotopes
• AAA has set-up a unique industrial process
to produce Radio Metabolic Therapy
products
• AAA facility in Ivrea about to be approved by
AIFA to produce therapeutic
radiopharmaceuticals in injectable form
– Likely to be first industrial pharmaceutical
laboratory for RMT products in the world
approved by a central authority
– To be followed by a second facility in Forli in
2011
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BioSynthema
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BioSynthema, located in St. Louis, Missouri, U.S, acquired
in June 2010
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Discovers and develops unique pharmaceuticals targeted
to cell surface receptors over-expressed by various
lesions
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Technology makes specific tumors highly visible using
diagnostic imaging methods, enabling earlier, more
accurate diagnosis and personalized therapy
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Developing new, effective products for diagnosis and
treatment of Gastero-Entero-Pancreatic NeuroEndocrine
Tumors (GEPNETs)
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Lead product Lutate has been proven safe and effective in
over 600 patients
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Reduces tumor size
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Extends life by 3.5 to 6 years
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Improves quality of life
Orphan drug status in EU and USA.
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expected to enter phase III in 2011
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U.S. marketing application expected in 2015
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Commercial network
AAA operates:
• Directly in 4 European countries
– France, Italy, Spain and Switzerland
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Through agents or distributors in 27
countries
– UK, Ireland, Belgium, Netherland,
Luxembourg, Norway, Denmark, Sweden,
Finland, Czech Republic, Turkey, Greece,
Austria, Germany, Slovakia, Hungary,
Poland, Romania, Bulgaria, Ukraine,
Portugal, Croatia, Serbia, Slovenia,
Bosnia, Montenegro, Macedonia
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Research & Development
• Strategy of continuously developing new
compounds to bring to market is implicit
in AAA’s mission statement : “Bridging
science with life”
• R&D department includes more than 30
people out of 130 employees
• Most opportunities for new MNM
products come from academia - public
partnerships as important as private
companies
• AAA working closely with 32 partners
(70% in the public and 30% in the private
sectors) on approx. 25 projects
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Next generation growth – product pipeline
Indication
Discovery
Apoptosis and
necrosis
Annexin
atherosclerosis
myocardial infarction
stroke
Atheroma peptide
myocardial
perfusion
estrogen
cancers
neuroendocrine
cancers
brachytherapy
Preclinical
Phase I
Phase II
Phase III
Filing
Diagnostics:
SPECT
Cardiogen®
Diagnostics:
PET
Er Carrier peptide
Lutate
THERAPEUTICS
Theranean
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Thank you for your attention
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