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Building the next generation biopharma

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Allergy franchise includes Zyrtec , Zyrtec D , Cirrus , Xyzal Allergy franchise ... Allegra Zyrtec Loratadine generics. 49.2% Xyzal U.S. transition in allergy ... – PowerPoint PPT presentation

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Title: Building the next generation biopharma


1
Building the next generation biopharma
  • Roch Doliveux
  • CEO

2
Agenda
  • UCB today
  • Acquisition of Schwarz Pharma
  • Research Development
  • Outlook 2007

3
World biopharma market 482 billion (7)
  • Pharmaceuticals (2006)Top 10 products global
    sales range 2.7 10.3 billionPharmaceutical
    Market Annual growth 4.6
  • Biologicals (2006)Top 10 products global sales
    range 1.6 3.3 billionBiologicals Market
    Annual growth 17.8

Source Evaluate March 20, 2007 and IMS Health
Global Pharmaceutical Report 06
4
Amongst original brands specialist driven market
is main source of growthPrimary care zero growth
in Europe
Original brands
Europe
North America
Source IMS Health MIDAS MAT December 2006
Ethical Non Generic Market Only
5
Primary care growth decline has affected major
playersUCB suffering in Primary care excellent
in Specialist driven
Source IMS Health MIDAS MAT Dec 2006
6
Biopharmaceutical leaders

Amgen
23
10.4
Genentech
23
5.7
Novo Nordisk
16
5.2
Merck Serono
22
4.0
UCB Schwarz
25
3.2
Genzyme
20
2.4
Investment in RD Net Sales 2006 ( billion)
UCB
28
2.2
Biogen IDEC
40
1.3
Lundbeck
21
1.2
Shire
25
1.1
Merck Ethicals only (excludes Generics, CHC and
Chemicals)
7
Vision - since 2004
  • To build a global biopharmaceutical leader,
  • based on unique blending of innovation,
  • entrepreneurship and proven experience,
  • bringing to specialists first, new medicines to
  • treat patients suffering from severe diseases.

8
2006Solid revenue and profit growth
2006 Revenue up 11 (8 as reported)
3000
2 523
2 341
2400
Keppra
36
Keppra
13
Xyzal
1800
Xyzal
0
million
Zyrtec
Zyrtec
1200
12
Royalties
Royalties
Other products
600
Other products
-9
0
2005
2006
... double digit profit growth, up 13 (36 as
reported)
on a like for like basis, excluding
contribution of divested businesses/products and
one-off items
9
Net sales Therapeutic areas
2005
2006
Allergy
CNS
Allergy
CNS
34
45
32
37
29
23
Others
Others
2.2 billion
2.0 billion
CNS Keppra, Nootropil, Metadate CD,
Atarax Allergy Zyrtec D, Zyrtec, Xyzal
10
UCB Schwarz Pharma strengthens and
diversifies specialty portfolio

UCB 2006 Net Sales (2.2 billion)
Pro Forma 2006 Net Sales (3.2 billion)
11
Net sales Geography
2005
2006
Europe
North America
Europe
North America
38
38
44
46
7
7
11
9
Emerging Markets
Emerging Markets
Japan
Japan
2.2 billion
2.0 billion
12
Leader in epilepsy and allergy
1 in Epilepsy (U.S.A. and E.U.)
1 in Allergy (Worldwide)
Source IMS (Value, US / EU5, MAT Q4/06)
Epilepsy only
13
Keppra Sustained high double-digit growth
Net sales 761 million in 2006
36
800
700
600
35
500
million
400
34
300
200
100
67
0
U.S.A.
Europe
Emerging markets
Total
2005
2006
14
Keppra New indications and formulation in
epilepsy
Geographic expansion South Korea Jan
2007 China Mar 2007
15
KeppraU.S.A. Market leader
29.1
Market share in value - epilepsy
Source IMS (Epilepsy market share in value, US,
MAT, Feb. 2007)
16
KeppraEurope Market leader
25.8
Market share in value - epilepsy
Source IMS (Epilepsy market share in value,
Europe, MAT, Feb. 2007)
17
Allergy franchiseContinuing solid performance
Net sales 704 million in 2006
800
2
600
million
400
12
0
-17
200
26
0
U.S.A.
Europe
Japan
Emerging markets
Total
2005
2006
Allergy franchise includes Zyrtec, Zyrtec D,
Cirrus, Xyzal
18
Zyrtec U.S.A. Market leader
49.2
Market share in value
Source IMS (Antihistamine group of products ,
Value, US, Feb. 07)
19
Xyzal U.S. transition in allergy
  • Significant branded prescription market
  • Xyzal superiority demonstrated versus
    competition
  • Potentially only promoted oral premium
    prescription anti-histamine
  • Positioned for leadership
  • Co-promotion with sanofi-aventis

U.S. launch expected during Fall 2007
Day JH et al. Comparative clinical efficacy,
onset and duration of action of levocetirizine
and desloratadine for symptoms of seasonal
allergic rhinitis in subjects evaluated in the
environmental exposure unit (EEU). Int J Clin
Pract 2004 58 109-18
20
Agenda
  • UCB today
  • Acquisition of Schwarz Pharma
  • Research Development
  • Outlook 2007

21
UCB Schwarz PharmaLeaping forward
?
  • Leaps forward into the next generation biopharma
    company
  • Strengthens leadership position in one of our
    strong franchises
  • Broadens late stage pipeline to accelerate
    sustainable topline growth into the next decade
  • Commercial organisation increased power in U.S.A.
    and E.U.
  • Additional earnings growth to fund RD
    investments
  • Significant anticipated synergies 300m p.a.
    within 3 years
  • Builds on complementary culture of both
    organisations and UCB's successful transaction
    integration track record
  • Improved long term earnings prospects and
    cash-flow profile

?
?
?
?
?
?
?
22
UCB Schwarz Pharma Status of acquisition
process
  • Tender offer completed on 28 December 2006
  • UCB owns today 87.6 of Schwarz Pharmas
    outstanding shares
  • Domination profit and loss transfer agreement
    (DA) process ongoing
  • Cash compensation of 104.60 per Schwarz Pharma
    share or guaranteed dividend of 3.43 per share
  • Schwarz Pharmas General Shareholders' Meeting
    (gt94) accepted all resolutions (gt98), including
    DA (May 8, 2007)

23
UCB Schwarz PharmaIntegration update
  • Both companies being restructured to address
    inefficiencies and new specialist driven business
    model
  • Arms length agreements to benefit Schwarzs and
    UCBs shareholders
  • Co-promotion of Neupro and Keppra
  • Co-promotion of Primary Care products
  • Advisory services
  • Purchasing
  • New organization planning from Day Onepost
    domination agreement
  • Synergies on track

24
Agenda
  • UCB today
  • Acquisition of Schwarz Pharma
  • Research Development
  • Outlook 2007

25
Rich and productive RD pipeline
UCB
Schwarz Pharma
26
Epilepsy
  • Most common serious neurological disorder
  • Recurrent seizures resulting from excessive
    electrical activity in the brain
  • Prevalence 50 million people worldwide
  • 2.2 million in Europe
  • 1.6 million in U.S.A.
  • 25 - 35 of patients are inadequately controlled

Source IMS MAT 06 total AED market
27
Keppra XR Solid succession plan in epilepsy
  • Potentially valuable new alternative
  • Expected improved efficacy and tolerability
    ratio
  • Add-on therapy for adult patients with
    refractory epilepsy suffering from partial onset
    seizures
  • Potential for monotherapy indication
  • Potential for once daily convenience and
    compliance

Phase III results expected in Q4 2007 Potentially
3 years of market exclusivity in the U.S.A.
28
Brivaracetam Solid succession plan in epilepsy
  • Different pharmacology than Keppra
  • 10 times more potent
  • More efficacious
  • Broader mechanism of action
  • Very strong efficacy in phase IIb evaluation
  • Robust efficacy and good tolerability
  • Population includes patients not controlled with
    Keppra

Phase III trials expected to start in Q2
2007 Orphan drug program in Unverricht Lundborg
Disease ongoing
29
Lacosamide Solid succession plan in epilepsy
  • Different mode of action than Keppra and
    brivaracetam
  • Convenient adjunctive therapy due to no drug-drug
    or food interaction
  • Easy twice daily dosing, good safety and
    tolerability
  • Oral dosing and IV formulation available
  • Expected to become a strong and convenient AED
    that is simple to use with multiple formulations
    and good tolerability
  • Positive phase III results in adjunctive therapy

Adjunctive therapy E.U. filed in May 2007 U.S.
filing expected in Q4 2007 Monotherapy Phase IIb
expected to start in H2 2007
30
Crohns disease
  • Chronic inflammatory disease of the entire
    gastrointestinal tract
  • Associated with episodes of relapse and remission
  • Prevalence
  • Approximately 1 million people worldwide
  • Over 500,000 patients in Europe
  • Over 545,000 patients in the U.S.A.
  • Over 19,000 patients in Japan
  • Market size US 0.7 billion

Gastro-duodenal and otherlt1
Isolatedsmall-intestine29
Isolatedcolon27
Isolatedanorectal3
Ileo-cecal41
Adapted from Truelove, Gut 1976 17(3) 192201
Source Decision Resources Reports Crohns
Disease January 2007
31
Cimzia Crohns disease
  • Demonstrated efficacy with a stable once
    monthlydosing proven in extensive phase III
    programme
  • Filed in the U.S.A. (February 2006) and E.U.
    (April 2006)
  • Full response to Complete Review Letter
  • Additional short-term clinical study
  • Provide additional clinical efficacy to confirm
    the induction of clinical response

Additional phase III study results expected in H2
2008
32
Rheumatoid arthritis
  • Chronic inflammatory disease characterised by
    progressive joint destruction
  • Debilitating systemic condition
  • Prevalence
  • Approximately 1 of the population
  • Over 2.2 million in Europe
  • Over 2.1 million patients in U.S.A.
  • Over 0.6 million patients in Japan
  • Market size US 4.6 billion

Source Decision Resources Reports RA May 2006
33
Cimzia Rheumatoid arthritis
  • Two positive large-scale phase III studies
  • RAPID 1 (027) and RAPID 2 (050)
  • Primary and co-primary endpoints met with
    statistical significance
  • Significant improvement in signs and symptoms
  • Significant reduction in joint damage after 1
    year (050/x-ray data)
  • Results to be presented at key congresses
  • EULAR (June 2007) and ACR (November 2007)

Regulatory submission expected by end 2007
34
Psoriasis
  • Chronic dermatological inflammatory disease
  • High morbidity
  • Prevalence
  • Estimated 2 of population
  • Over 4.5 million in Europe 4.1 million in the
    U.S.A.
  • Market size US 0.6 billion

Source Decision Resources Reports Psoriasis
September 2006
35

Cimzia Psoriasis
  • Demonstrated efficacy in moderate to severe
    chronic plaque psoriasis in phase II study (040)
  • Retreatment study (044) ongoing
  • Preparation for next steps ongoing

Additional phase II results expected in Q3 2007
36
Parkinsons disease
  • Progressive neurological disease
  • Characterized by loss of dopamine containing
    cells
  • Leading to impaired movement control
  • Prevalence 4 million patients world-wide
  • Market size US 2.9 billion

37
Neupro Parkinson's disease
  • First once a day non-ergolinic dopamine agonist
  • First transdermal patch for treatment of
    Parkinsons disease
  • 24-hour coverage for signs and symptoms of
    Parkinsons disease

A new Parkinson's therapy is taking shape
Early stage Parkinson Launched in
Europe Approved in U.S.A. Advanced Parkinson
Approved in Europe Planned sNDA filing 2H2007
38
Restless legs syndrome
  • Neurological disorder
  • Characterized by deficiency in the dopaminergic
    system
  • Resulting in motor restlessness, poor quality of
    sleep, excessive daytime sleepiness, traffic
    safety issues
  • Prevalence 10 of population
  • Market size US 350 million

39
Rotigotine Restless legs syndrome
  • Transdermal system
  • Outstanding efficacy in Restless Legs Syndrome,
    well tolerated and safe confirmed in two
    phase III trials
  • Evidence of improved sleep and reduced daytime
    tiredness
  • Excellent chance to become first line treatment
    for this large unmet medical need
  • Potential to become first-line therapy

Restless Legs Syndrome (RLS) increased
awareness of the unrecognized disease
Expected U.S. E.U. regulatory filing by end 2007
40
Diabetic neuropathic pain
  • Permanent damage of nerves caused by metabolic
    disorder
  • Chronic pain, sensations of burning, electricity,
    extreme cold, numbness and tingling
  • Prevalence 11 million patients worldwide
  • Market size US 3.5 billion

41
Lacosamide Diabetic neuropathic pain
  • Promising drug for a growing market with large
    unmet medical need
  • Strong and sustained efficacy in reducing
    diabetic neuropathy
  • Good tolerability and safety profile
  • No drug-drug or food interactions or weight gain
  • Different mode of action

E.U. filing expected in Q3 2007 U.S. filing
expected in Q4 2007
42
Agenda
  • UCB today
  • Acquisition of Schwarz Pharma
  • Research Development
  • Outlook 2007

43
Focus for 2007
  • Maximize Keppra and prepare for expansion of
    epilepsy franchise
  • Launch Cimzia in Crohns, Neupro in Parkinsons
    and Xyzal in U.S.A.
  • Realise synergies
  • Reach major Research, Development and Regulatory
    milestones
  • Cimzia CD approval, Rheumatoid Arthritis filing
  • Xyzal Allergy, Approval in U.S.A.
  • Keppra XR Epilepsy, complete phase III trials
  • brivaracetam Epilepsy, start phase III trials
  • Neupro Advanced Parkinson approval in U.S.A.
    Restless Legs
    Syndrome filing
  • lacosamide Filings in U.S.A. and Europe for
    Epilepsy and Diabetic Neuropathic Pain

44
UCB Next generation biopharma leader
Significant long-term growth
Breakthrough
Unique science for unique medicines to meet
unmet medical needs
Intense growth
Rich pipeline bears fruits
Execution
New product launches RD investments Continuous
cost improvement Change in product portfolio
2007-2009
... and beyond
2010
45
UCB Next generation biopharma leader
  • Rich pipeline especially in neurology and
    inflammation
  • World-leading RD capability with unique science
  • Global commercial scale with a broader range of
    specialist products
  • Leading neurology company
  • Leverages UCBs proven sales and marketing
    network
  • Complementary entrepreneurial talent base
  • Significant synergy generation

46
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