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patient-centric global biopharmaceutical Union Chimique Belge 1 2 ABOUT UCB (2012) Biopharmaceutical company in more than 40 countries 9000 employees 3.482 billion in 2012 3 4 5 6 7 8 9 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 10 11 ZYRTEC® 12 WHAT IS ZYRTEC®? Active substance : Cetirizine Mechanism of action: Strong antagonist of peripheral H1 receptors, antihistamine Indication: Allergies 13 ZYRTEC® REVENUE Loss of 53 % of the sales 2011 : 260 2012: 249 14 AND KEPPRA WILL LOOSE ITS PATENT IN 2009! 15 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 16 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………. 17 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 19 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 20 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 21 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……… 22 2 MAJOR THERAPEUTIC AREAS IMMUNOLOGY ZYRTEC® CIMZIA® CNS KEPPRA® VIMPAT® NEUPRO® 23 IMMUNOLOGY 24 CIMZIA® 25 WHAT IS CIMZIA®? The first pegylated antibody A new PEGylated anti-TNF PEG improved drug solubility and stability Extended circulating life Reduced dosage frequency 26 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. 27 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 28 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 29 30 31 32 CNS 33 KEPPRA® LEVETIRAC ETAM 34 KEPPRA® Different from the mechanisms of current antiepileptic medicinal products 35 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 36 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 37 UCB ANTIEPILEPTIC EXPERIENCE 38 39 IN 2009… Keppra losses its patent in US…. But Launch of KEPPRA XR once-a-day extended-release epilepsy medication 40 KEPPRA® REVENUE Decrease since 2008 41 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 42 UCB acquires Schwarz Pharma in 2007 for $4.4 billions 43 VIMPAT® LACOSAMIDE 44 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. 45 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 46 47 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 48 VIMPAT® REVENUE 49 NEUPRO® ROTIGOTINE 50 WHAT IS NEUPRO? Transdermal patch of levodopa for every stage of parkinson disease. Developed by Schwarz Pharma 51 WHAT IS NEUPRO? 2 indications: Parkinson’s disease (4 million patients) Restless legs syndrom (52 million people) Available in 20 countries 52 NEUPRO® REVENUE 53 54 55 56 UCB’S OTHER PRODUCTS 57 58 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 59 UCB’S PERSPECTIVES IN DRUG DEVELOPMENT 60 61 62 63 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). 64 65 RESEARCH: AN EXPERTISE IN SLAM AND IN TARGETING SV2A 66 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 67 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) 71 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 … 72 www.ucb.com UCB’S STRATEGY 73 74 75 UCB FINANCIAL ANALYSIS 76 77 78 79 80 81 82 83