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Company Data, Credit Suisse Analysis Slide 4 September 2013 Our Top-10 Sound Bites/Observation/Questions/Focal Points for the Conference(Cont.)

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Company Data, Credit Suisse Analysis Slide 4 September 2013 Our Top-10 Sound Bites/Observation/Questions/Focal Points for the Conference(Cont.) Global Biotechnology and Pharmaceuticals 24th September 2013 Multiple Sclerosis – ECTRIMS 2013 Prep-Pack It’s A Revolution! But Just How Big? Research Analysts Ravi Mehrotra, Ph.D. 212-325-3487 [email protected] EU Pharma Team Koon Ching, Ph.D. Vamil Divan Lee Kalowski 44 20 7888 0304 212 325 6286 212 538 5394 212-325-3777 [email protected] [email protected] [email protected] [email protected] Ari Jahja Ronak Shah, Pharm.D., CFA Anuj Shah Jason Kantor 212 325 0767 212 325 9799 212 325 6931 415 249 7942 [email protected] [email protected] [email protected] [email protected] DISCLOSURE APPENDIX CONTAINS IMPORTANT DISCLOSURES, ANALYST CERTIFICATIONS, INFORMATION ON TRADE ALERTS, ANALYST MODEL PORTFOLIOS AND THE STATUS OF NON-U.S ANALYSTS. U.S. Disclosure: Credit Suisse does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the Firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. Evolution AND Revolution! As a humorous point/observation, we find the titles of the two Biogen sponsored symposium to be held at ECTRIMS very interesting: 10/2 17.15 “Biogen Idec: Reinventing MS care – Evolution” and 10/3 07.45 “Biogen Idec: Reinventing MS care – Revolution”. Umm, we wonder where they got that inspiration from… Slide 2 September 2013 Table of Contents: It’s A Revolution! At ECTRIMS 2013, we are focused on these particular areas: 1) Dynamics of Tecfidera’s launch - Warehoused vs. +/ - Three bucket hypothesis 2) Other new entrant dynamics – Aubagio, Laquinimod 3) Earlier and treat-to-goal treatment management 4) Increasing focus on MRI in diagnosis and treatment ECTRIMS 2013 – Introduction/Key summary slides ………………………….............................................. 4 ECTRIMS 2013 – Key Must-Attend Sessions………………………………….............................................. 22 ECTRIMS 2013 – Sessions by Day…………………………………………………………………………….... 35 ECTRIMS 2013 – Sessions by Product.……………………………………………………………………….... 56 3 Buckets Thesis…………………………………………………………………….......................................... 72 New MS Drugs – Drug Profiles…………………………………………………………………………………... 82 Biogen Idec: BG-12………………………………........................................................................................ 89 Sanofi: Aubagio (Teriflunomide)…………………………………………………………………………………128 Sanofi / Bayer: Lemtrada…………………………………………………………………………………………138 Biogen Idec / AbbVie: Daclizumab…………………………………………………………………………....... 146 Roche / Biogen Idec: Ocrelizumab…………………………………………………………………………….. 151 Teva / Active Biotech: Laquinimod……………………………………………………………………………… 158 Novartis: Gilenya…………………………………………………………………………………………………. 164 Biogen Idec/Elan: Tysabri……………………………………………………………………………………….. 169 Appendix - Additional Background Slides……………………………………………………………………… 175 Slide 3 September 2013 ECTRIMS 2013: It’s a Revolution! – But Just How Big? . In our view, it’s not a question of whether it is a revolution or evolution anymore; the MS market IS undergoing a revolution! . The question is now just how big a revolution (and for investors what is not priced into the stocks!) . This revolution in the clinical management of MS is being driven not only by the launch of next-gen agents but also by changing treatment and diagnosis paradigms. The consequence of this revolution is that MS is rapidly changing from a “diagnose, treat, and see” to a “treat aggressively to the goal” therapeutic area. The upcoming ECTRIMS meeting (Copenhagen Oct 2-5), will deliver incremental clinical data (rather than key pivotal data) for next-gen MS agents. More importantly, the meeting will act as an important “front-line forum” to gauge the massively changing dynamics within the MS therapeutic area. Within this pre-pack, we provide (1) An itinerary planner for the meeting arranged by “must attend”, “day-by-day” and “MS Therapy” (2) A MS market overview and (3) Next-Gen agent profiles Sources: Company data, Credit Suisse analysis Slide 4 September 2013 Our top-10 sound bites/observation/questions/focal points for the conference(cont.) . (1) “Warehoused” untreated MS population remains an important sensitivity. (2) Earlier and “treat-to-goal” like management to drive a dynamic market. (3) Increasing focus on MRI clinical measures in diagnosis and treatment . (4) Is our “three buckets hypothesis” still valid? . (5) Is price of drugs influencing treatment choices? . (6) What is interesting in the earlier stage development pipeline? . (7) How do physicians view the relative clinical efficacy of MS therapeutics? . (8) How will the treatment sequencing change? . (9) What is the emerging side effect profile of Tecfidera? (especially (a) Is PML a real gating point concern?; (b) What is the real world flush/GI impact?) . (10) How do physicians view Tecfidera leukocyte and lymphocyte monitoring? Sources: Company data, Credit Suisse analysis Slide 5 September 2013 ECTRIMS 2013: Incremental data on next-gen agents . Tecfidera (BIIB): 3-year, follow-up integrated (efficacy inc MRI) data from DEFINE, CONFIRM, and ENDORSE. A long-term, interim update on safety from the ENDORSE study (10/3 at 15:45-17:00: P537, P563; 10/4 at 15:30-17:00: P990, P1013, P1018) . Plegridy (BIIB): Further efficacy and safety analyses of ADVANCE data will be presented. (10/3 at 15:45-17:00: P539, P540; 10/4 at 15:30-17:00: P989, P1061) . Aubagio/ Lemtrada (Sanofi): Pooled efficacy and safety PIII data/3-year disability, safety data + lymphocyte dynamics in CARE-MS II data. (10/3 at 15:45-17:00: P544, P618, P633; 10/4 at 15:30- 17:00: P1093, P1095) . Laquinimod (TEVA/Active Biotech): PIII CONCERTO trial design for 0.6mg and 1.0mg doses. (10/4 at 15:30-17:00: P1054) . Gilenya (Novartis/Mitsubishi): Long-term efficacy FREEDOMS II data. (10/4 at 15:30-17:00:P1092) . RPC1063 (RCPT): Focus will be on PI and QT/QTc data. (10/3 at 15:45-17:00: P375; 10/4 at 15:30- 17:00: P983) . Ponesimod (ATLN), ONO-4641 (Ono/ Merck KgaA): Additional PII data will be presented. (10/4 at 15:30-17:00: P995) . Siponimod (Novartis): PI QT/QTc data on "placebo-like" AV effects will be of interest. (10/3 at 15:45- 17:00: P626) . Ocrelizumab (BIIB/Roche)/Daclizumab (BIIB/ABBV). No major new data, but Roche is hosting a whole symposium devoted to B-cell therapy. Sources: Company data, Credit Suisse analysis Slide 6 September 2013 3 Buckets Thesis: Our View on the Potential Evolution of the MS Market Current Treatment Options - $14B (2012) Potential Future Treatment Options - $19B (2018) ABCRs High-Efficacy/ ABCRs Orals High-Efficacy/ Second-Line Second-Line Avonex – BIIB Tysabri – BIIB/ELN The 2012-2018 Avonex – BIIB Tecfidera – BIIB Tysabri – BIIB/ELN Betaseron – BAY Gilenya – NVS MS Revolution Betaseron – BAY Aubagio – SNY Lemtrada – SNY Copaxone – TEVA Copaxone – TEVA Gilenya – NVS Ocrelizumab – ROG/BIIB Rebif – PFE/eMRK Rebif – PFE/eMRK Laquinimod – ACTI/TEVA Approved Drugs Plegridy – BIIB Daclizumab – BIIB/ABBV ca80% market share ca20% market share Pipeline Drugs RPC1063* – RCPT Efficacy: RR 20-30% Efficacy: RR >50% Efficacy: EDSS <25% EDSS >30% > or = to ABCRs Key Points to Our 3 Bucket Thesis: (1) We view MS therapeutics in 3 broad buckets: Two established buckets (i) ABCR and (ii) High-Efficacy/Second-Line agents and an emerging new class of products that we call (iii) Oral agents (2) The overall MS market is still dominated (~80% market share by value) by ABCRs (despite their relative modest efficacy and less than ideal side effect profile) as they are the only alternatives to High-Efficacy/Second-Line agents (~20% market share by value) and their associated serious infections concerns (3) Tecfidera is the leading Oral, showing efficacy above ABCRs/near High-Efficacy/Second-Line AND possessing a better safety profile than High-Efficacy/Second-Line (and ABCRs). In our view this will allow significant market share in new patients, but also propagate significant switching from ABCRs (4) RPC1063 is an S1P1 modulator, within the same class as Gilenya. In our view, the totality of RCP1063’s clinical profile, notably improved half-life/fast recovery of lymphocytes and improved cardiotoxicity/hepatoxicity over Gilenya could effectively position RCP1063 in a different bucket relative to Gilenya Sources: Company data, Credit Suisse research MS Drug Launch Timeline 1997 2009 2011 2013 2015 2017 1993 1996 2002 2004 2006 2010 2012 2014 2016 2018 Betaseron Extavia Daclizumab Avonex Rebif Gilenya Plegridy RPC1063 Copaxone Tysabri Aubagio Ocrelizumab U.S. Tecfidera Laquinimod Lemtrada Betaseron Tysabri Gilenya Daclizumab Avonex Extavia Aubagio RPC1063 Copaxone Lemtrada Rebif Tecfidera Ex-U.S. Plegridy ABCRs Laquinimod Orals High-Efficacy / 2nd-Line Ocrelizumab Sources: Company data, Credit Suisse research Multiple Sclerosis clinical development pipeline Phase I Phase II Phase III SP F F ABT-413 ARX424 Masitinib RPC1063 Lemtrada Plegridy AbbVie AbbVie AB Science Receptos Sanofi Biogen Idec F SP ATX-MS-1467 AZ01 BHT-3009 Ponesimod Generic Copaxone Siponimod Merck KGaA Allozyne Bayhill Actelion Momenta / Novartis Novartis SP CS-0777 ER IFNβ1a Tcelna Secukinumab Daclizumab Laquinimod Daiichi Flamel Opexa Novartis Biogen Idec / AbbVie Teva / Active Biotech Fc-Interferon LAS186323 Anti-LINGO-1 Ofatumumab NU100 Ocrelizumab Merck KGaA Almirall Biogen Idec GSK Nuron Biotech Roche / Biogen Idec SP MOR103 NRT-36 ATL1102
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