Transcript SWOT - Moodle Lille 2

patient-centric global biopharmaceutical
Union Chimique Belge
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ABOUT UCB (2012)
Biopharmaceutical company
in more than 40 countries
9000 employees
3.482 billion in 2012
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HISTORY:
CENTURY OF DISCOVERY
1960s – 1990s
Most important pharmaceutical
discovery(Nootropyl®, Zyrtec®, Keppra®)
Visionary research into biotechnology
Expansion in other continent
1950s
First therapeutic breakthoughs
1920s -1940s
Creation of UCB (1928)
 primarily focusing on industrial chemicals
 Expansion into industrial films and pharmaceutical research
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ZYRTEC®
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WHAT IS ZYRTEC®?
 Active substance : Cetirizine
 Mechanism of action: Strong antagonist of peripheral H1
receptors, antihistamine
 Indication: Allergies
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ZYRTEC® REVENUE
Loss of 53 % of
the sales
2011 : 260
2012: 249
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AND KEPPRA WILL LOOSE ITS PATENT IN
2009!
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CENTURY OF GREAT CHANGES
2000-2004
Becoming a pharmaceutical compagny
 Transformation into a pure biopharma started
 Sell of surface specialties
 Acquired the leading British biotechnology company,
Celltech
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UCB TRANSFORMATION :
To become a global biopharma leader
Before 2004
films
Pharmaceutical
Chemicals
UCB in 2004
UCB annual report 2010
Wants to become a
biopharma
With……….
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Becoming a Pharmaceutical company
UCB activities in 2004
Pharma
Surface Specialties
Pharma
Surface Specialties18
UCB annual report 2004
UCB TRANSFORMATION :2004
Keppra+Zyrtec
= 67% of revenue
Strong knowledge in CNS & allergy with Nootropil, Keppra and Zyrtec
BUT
Biopharmaceuticals drugs are
• more innovative
• complex molecules,
• expensive to manufacture,
• hard to manufacture for a generic company
UCB annual report
2004
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UCB TRANSFORMATION : HOW?
1st
Because a big transformation needs big money…
UCB sells all out-of area strategies
2004
Divestment of Surface specialities sector:
Sale of film business
Sale of speciality chemical business
€ 320 millions
€ 1.415 millions
€ 1.735 millions
2nd
2006
Divestment of UCB-Bioproducts € 120 millions
Peptide synthesis
But UCB has no knowledge in biopharma…
UCB annual report 2004 and 2006
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UCB TRANSFORMATION : HOW
UCB acquires Celltech in 2004 for $2.7
billions
Celltech is an English Biotechnology company created in 2000
 CelltechChiroscience (leader in advanced antibody
technologies)
 Medeva PLC: Small molecules company
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UCB TRANSFORMATION :
consolidation with Celltech
2 Therapeutic areas
CNS
CNS
Allergy/Respiratory
4Therapeutic areas
Allergy/
Oncology
Respiratory
Inflammation
During 2005, global sales were increased by 11% and well as
R&D expenses (325M in 2004 vs 511M in 2005)
But UCB needs new drugs on the market………
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2 MAJOR THERAPEUTIC AREAS
IMMUNOLOGY
ZYRTEC®
CIMZIA®
CNS
KEPPRA®
VIMPAT®
NEUPRO®
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IMMUNOLOGY
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CIMZIA®
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WHAT IS CIMZIA®?
The first pegylated antibody
A new PEGylated anti-TNF
 PEG improved drug solubility and stability
 Extended circulating life
 Reduced dosage frequency
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INDICATIONS
Crohn’s Disease
 In 2008 the FDA approved Cimzia for the treatment of
Crohn's disease in people who did not respond sufficiently
or adequately to standard therapy.
 In 2009 the CHMP refused approval for the treatment of
Crohn's disease.
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INDICATIONS
Rheumatoid Arthritis
 In 2009, the CHMP issued a positive opinion recommending
a marketing authorisation for Cimzia for the treatment of
rheumatoid arthritis
 In 2009, the FDA for Adult Patients Suffering From Moderate
to Severe Rheumatoid Arthritis
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INDICATIONS
Psoriatic Arthritis
 In september 2013, the FDA approved Cimzia for use in the
United States for the treatment of adult patients with active
psoriatic arthritis
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CNS
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KEPPRA®
LEVETIRAC ETAM
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KEPPRA®
Different from the mechanisms of current antiepileptic medicinal products
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http://www.cimzia.com
EPILEPSY
50 millions people worldwide
Incidence in developed countries 50/100,000
person-years
Incidence increases in developing country:
Africa
63-158 /100,000 person-years
Latin America 78-190/100,000 person-years
High unmet medical need in 1/3 of treated epilepsy patients
Keppra: one of the most prescribed drug for epilepsy
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UCB annual report 2009
UCB ANTIEPILEPTIC EXPERIENCE
About 50 millions people worldwide
300,000 U.S people have a first convulsion each year
The major firms include:
- Abbott laboratories
- Cephalon
- GSK
- J&J
- Novartis AG
- Pfizer
- Sanofi-Aventis SA
- Shire
- UCB Pharma
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UCB ANTIEPILEPTIC EXPERIENCE
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IN 2009…
Keppra losses its patent in US….
But Launch of KEPPRA XR 
once-a-day extended-release epilepsy medication
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KEPPRA® REVENUE
Decrease since
2008
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CENTURY OF GREAT CHANGES
2008 -2010
Keppra® will loose its patent in
U.S 2009/Europe in 2010
2005- 2007
January 2007 Acquisition of the German Schwarz Pharma
2000-2004
Acquisition of the British biotechnology company,
Celltech
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UCB acquires Schwarz Pharma in 2007 for $4.4 billions
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VIMPAT®
LACOSAMIDE
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WHAT IS VIMPAT?
 In 2000, SCHWARZ PHARMA partnered with Harris Corporation
to complete the development and commercialization of
lacosamide
 Precise mechanism of action is unknown. Lacosamide
selectively enhances slow inactivation of voltage -gated sodium
channels, resulting in stabilization of hyperexcitable neuronal
membranes and inhibition of repetitive neuronal firing.
 Phase 3: multicenter, double-blind, placebo-controlled trial.
Patients were randomized to placebo or lacosamide 200, 400,
or 600 mg/day after an 8 -week baseline period.
Result: adjunctive lacosamide significantly reduced seizure
frequency.
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June 2008: positive opinion of the CHMP as adjunctive therapy for the treatment of
partial-onset seizures with or without secondary generalisation in adult and
adolescent (16-18 years) patients with epilepsy
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 Reaching more than
135000 patients
 Available in 23
countries
 4 additional
development projects:
 Diabetic neuropathic pain
 adjunctive therapy pGtCS
 monotherapy (Europe
and U.S.)
 paediatric adjunctive
therapy
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VIMPAT® REVENUE
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NEUPRO®
ROTIGOTINE
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WHAT IS NEUPRO?
Transdermal patch of levodopa for every stage of parkinson
disease.
Developed by Schwarz Pharma
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WHAT IS NEUPRO?
 2 indications: Parkinson’s disease (4 million patients)
Restless legs syndrom (52 million people)
 Available in 20 countries
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NEUPRO® REVENUE
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UCB’S OTHER
PRODUCTS
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THE ONLY CELLTECH SMALL DRUGS KEPT BY UCB
XYREM® FILED IN FIBROMYALGIA
FIBROMYALGIA CHRONIC SYNDROME
- characterised by widespread muscle pain, stiffness and tenderness at specific points
- Around 14 millions people
BUT on 17th March 2011
- No prescription medicines approved yet for fibromyalgia in Europe
REJECT OF TYPE II VARIATION BY E.M.A.
known on the street as a "date rape drug".
UCB annual report 2010
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UCB’S PERSPECTIVES IN DRUG
DEVELOPMENT
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Romosozumab
A humanized monoclonal antibody that
binds to and inhibits sclerostin, a
protein secreted by bone cells that
inhibits bone formation.
The role of sclerotin was discovered at
Celltech in 1998
By binding to and blocking sclerostin,
romosozumab is designed to increase
the amount of bone in the skeleton.
In 2002, Cellgene signed a deal with Amgen to develop Romosozumab.
Amgen and UCB are collaborating on the development of romosozumab
for the treatment of bone-related conditions, including post-menopausal
osteoporosis (PMO).
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RESEARCH:
AN EXPERTISE IN
SLAM
AND
IN TARGETING SV2A
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I/ SLAM: Selected Lymphocyte Antibody Method
February 6, 2001
Celltech announce an agreement with Abgenix which provides Celltech
with extensive rights to use Abgenix's proprietary SLAM technology, for
rapid selection in vitro of high affinity antibodies including the direct
selection of fully human antibodies.
This is the first licence by Abgenix of the technology platform it obtained
when it acquired ImmGenics Inc., in December 2000
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Homogeneous primary screening assay
B cells extracted from
immunized animals
B cells in culture ≈ 250 000 wells
(5000cells/w)
7500 positives
Supernatant is mixed with either antigen coated beads (A) or antigen expressing cells (B), together with a
Cy5 labeled anti-IgG Fc antibody.
Where specific antibody, conjugate, and antigen come together, the beads or cells fluoresce and a hit are
recorded by the imaging software.
Antigen-specific B cell identification and selection
Single B cell isolation
During the short culture time the B cell secretes antibody.
The specific antibody binds to either antigen (Ag) coated beads (A) or cells expressing antigen
(B) in the vicinity of the B cell, producing a concentrated area of antibody.
The fluorescein-labeled anti-IgG Fc antibody binds to the secreted antibody producing a halo of
fluorescence surrounding the specific B cell.
Antibody Humanization
From each cell picked, cDNA is prepared directly from the lyzed cells and is used to
clone and sequence the antibody heavy and light chain variable region genes.
II/ SV2A : «Synaptic vesicle protein SV2A »
 SV2A protein is a presynaptic protein that
binds Keppra®
 A unique mechanism of
action (no modulation of
ion channels,
neurotransmitter
receptors or pathway
enzymes)
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II/ SV2A : «Synaptic vesicle protein SV2A »
• Target Validation:
• Studying the function of SV2 proteins
• Understanding the patho-physiological basis of epilepsy
• Refining the treatment of epilepsy and other neurological
disorders involving abnormalities in neural excitability.
• Hit discovery :
• Screen a small molecules library (MTS or HTS up to 106
compounds).
• Hit to Lead and Lead optimization
• Medicinal chemistry / PD / PK …
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www.ucb.com
UCB’S STRATEGY
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UCB FINANCIAL
ANALYSIS
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