-Examination of key pipeline candidates with in-depth clinical and commercial profiles of Phase III candidates

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1 Brochure More information from Pipeline Insight: Lymphomas, Multiple Myeloma & Myelodysplastic Syndromes - Optimization of clinical practice creates opportunities for emerging therapies Description: Introduction The commercial success of Rituxan in the treatment of NHL and Velcade and Revlimid in the treatment of MM has attracted the interest of pharmaceutical companies to these markets. There are 173 drugs in clinical development for these indications, the majority of which are molecular targeted therapies (MTTs). This contrasts with HL and MDS where there is limited pipeline activity. Scope -Examination of key pipeline candidates with in-depth clinical and commercial profiles of Phase III candidates -Seven major pharmaceutical market sales forecasts for Phase III pipeline products through to 2019 with product-specific assumptions Highlights There are currently 107 drugs in clinical development for NHL, of which 12 are in late phase development. This high R&D activity is due to the diverse nature of the diseases and the success of therapies such as Rituxan in these indications. Targeted therapies account for over half of drugs in development for NHL. There are currently 15 drugs in clinical development for HL, of which 3 are in late phase development. Unmet needs persists in HL but are confined to relapsed patients and elderly patients, which are relatively small patient populations. There are currently 66 drugs in clinical development for MM, of which 8 are in late phase development. MM is an incurable disease and there is a need for better and less toxic therapies across all lines of treatment. Reasons to Purchase -Segmentation and analysis of the current pipeline by developmental phase, drug class and company -Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs Contents: Overview Catalyst Summary Executive Summary Strategic scoping and focus Datamonitor insight into the disease market Contributing experts Related reports Upcoming related reports 1. Pipeline Overview and Dynamics Key findings Pipeline overview Pipeline summary The majority of drugs in late-phase development for lymphoma and multiple myeloma are targeted therapies.

2 Non-Hodgkin's lymphomas are targeted by drug developers more often than Hodgkin's lymphoma, multiple myeloma or myelodysplastic syndromes Targeted therapies account for over half of non-hodgkin's lymphoma drugs in clinical development Drug developers have shown relatively little interest in myelodysplastic syndromes Comparative forecasts Drugs in late-phase development for non-hodgkin's lymphomas will achieve combined sales of $676m by R&D Approach Key findings Clinical trial design in lymphomas, multiple myeloma and myelodysplastic syndromes Patient selection Increasingly significant in the era of targeted treatment Clinical trial duration Sufficient follow-up is necessary to establish true clinical benefit The advent of novel therapies Diversity of targeted therapies will require an evolution in clinical trial design Clinical trial endpoints in hematological malignancies Most oncology clinical trials designate multiple endpoints Survival Quality of life Response rates Toxicity Time to progression 3. Non-Hodgkin's Lymphoma Key findings Disease overview - market potential Definition of non-hodgkin's lymphomas (NHL) NHL is a broad classification given to a group of heterogeneous lymphomas Patient segmentation NHL is classified under the WHO classification system NHL can follow an aggressive or indolent disease course The Ann Arbor Staging Classification is of limited prognostic use International Prognostic Index (IPI) for aggressive NHL Immunophenotype differs between NHL subtypes Several genetic abnormalities are linked to NHL Molecular profiling in NHL Epidemiology Incidence of NHL will reach over 140,000 in the seven major markets by 2019 Incidence of non-hodgkin's lymphoma (NHL) by subtype in the seven major markets Distribution of NHL subtypes varies considerably across the seven major markets Incidence of diffuse large B-cell lymphoma (DLBCL) DLBCL is the most common aggressive lymphoma in the seven major markets Incidence of follicular lymphoma (FL) FL is the most common indolent lymphoma in the seven major markets Incidence of cutaneous T-cell lymphoma (CTCL) There are limited data on the incidence of CTCL Current treatment options Radiotherapy Chemotherapy First-line therapy Treating relapsed/refractory disease Stem cell transplantation Current comparator therapies Rituxan Unmet need in NHL More effective agents for the treatment of T-cell lymphomas More effective therapies are required for relapsed/refractory disease Agents with fewer side effects than currently available chemotherapies are required Higher remission rate in indolent lymphomas Target product profile versus current level of attainment Pipeline analysis and forecasts Pipeline summary Comparative forecasts

3 Afinitor (everolimus; Novartis) Afinitor is in Phase II trials as a maintenance therapy for poor-risk diffuse large B-cell lymphoma patients Afinitor showed satisfactory activity in Phase II trial in pretreated lymphomas Datamonitor drug assessment summary for Afinitor Overall cure rates in diffuse large B-cell lymphoma (DLBCL) are high, but new treatments are needed for relapsed and refractory patients Arzerra (ofatumumab; Genmab/GlaxoSmithKline) Head-to-head study versus Rituxan initiated in diffuse large B-cell lymphoma Genmab failed to demonstrate significant efficacy in pivotal Phase III trial in follicular lymphoma (FL) Encouraging data in first-line follicular NHL in combination with CHOP Failure of Phase III follicular NHL trial is a significant setback for Arzerra Phase III trial head-to-head with Rituxan in DLBCL will increase the chances of commercial success Arzerra will benefit from GlaxoSmithKline's expertise Datamonitor's drug assessment summary for Arzerra Avastin (bevacizumab; Genentech/Roche) It is unclear whether the addition of Avastin to R-CHOP improves outcomes in DLBCL Datamonitor drug assessment summary for Avastin BiovaxID (Accentia Biopharmaceuticals) Phase III study shows that maintenance BiovaxID prolongs disease-free survival in follicular lymphoma Phase II data in mantle cell lymphoma show that BiovaxID treatment is feasible in B-cell-depleted patients BiovaxID's positive Phase III data represent an important milestone for therapeutic vaccines......but clinical relevance of the data is doubtful As a personalized vaccine, BiovaxID will have to overcome major economical and logistical barriers Rituxan will provide fierce competition for BiovaxID in the first-line maintenance setting Enzastaurin (Eli Lilly) Enzastaurin shows marginal single-agent activity in relapsed/refractory DLBCL The response rates in the Phase II trial are not very impressive Enzastaurin may have to compete with Afinitor and Revlimid if approved as a maintenance therapy for DLBCL

4 Eli Lilly would have to overcome physician skepticism about the role of maintenance therapies in the treatment of DLBCL if enzastaurin gained approval for this indication. There is a high cure rate for DLBCL and therefore the concept of using maintenance therapy for this disease remains questionable. Maintenance therapy is widely used in the treatment of indolent lymphomas like follicular lymphoma, but currently not commonly used to treat aggressive lymphomas like DLBCL (Datamonitor, Stakeholder Insight 2009: Non-Hodgkin's lymphomas December 2009, DMHC2532). Furthermore, enzastaurin could face considerable competition from Afinitor (everolimus; Novartis) or Revlimid (lenalidomide; Celgene) because these drugs are also in development as maintenance therapies for relapsed or refractory DLBCL. Datamonitor drug assessment summary for enzastaurin Forodesine (BioCryst Pharmaceuticals) Better therapies are needed to treat relapsed/refractory cutaneous T-cell lymphoma Datamonitor drug assessment summary for forodesine Pixuvri (pixantrone; Cell Therapeutics) FDA approval for Pixuvri now unlikely if the drug now has a brand name this has to be consistent through the whole of the report... Cell therapeutics will have to decide if they want to instigate further trials Revlimid (lenalidomide; Celgene) Phase III trial of Revlimid in diffuse large B-cell lymphoma was planned in December 2008 Revlimid shows single-agent activity in relapsed/refractory DLBCL patients Revlimid has also demonstrated single-agent activity in mantle cell lymphoma (MCL) Revlimid is in Phase II trials for the treatment of indolent lymphomas There is high unmet need for relapsed mantle cell lymphoma patients making Revlimid's approval likely in this indication Celgene may be having problems with the maintenance trial for DLBCL Datamonitor drug assessment summary for Revlimid Velcade (bortezomib; Takeda/Johnson & Johnson) The combination of Velcade (bortezomib) with Rituxan (rituximab) is active in the first-line treatment of indolent non-hodgkin's lymphomas (NHL) Takeda has been investigating combination regimens containing Velcade in the treatment of lymphoma Physicians are interested in less toxic treatments for follicular lymphoma It seems likely that Velcade will gain approval for the treatment of follicular lymphoma Datamonitor drug assessment summary for Velcade 4. Hodgkin's Lymphoma

5 Key findings Disease overview - market potential Definition of Hodgkin's lymphomas (HL) HL is characterized by the presence of Reed-Sternberg cells Patient segmentation There are two distinct types of Hodgkin's Lymphoma (HL) Classical Hodgkin's lymphoma (CHL) Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL) Staging and risk assessment Epidemiology Incidence of HL will reach over 18,000 in the seven major markets by 2019 Current treatment options Initial therapy is a combination of radiotherapy and chemotherapy Autologous stem cell transplantation is recommended for relapsed patients Treatment outcomes are good for most patients Current comparator therapies Unmet need in Hodgkin's lymphoma More tolerable agents Treatments for relapsed patients Treatments for elderly patients Target product profile versus current level of attainment Pipeline analysis and forecasts Pipeline summary Comparative forecasts Brentuximab vedotin (SGN-35; Seattle Genetics/Takeda) The greatest unmet need in Hodgkin's lymphoma is in the relapsed/refractory setting Key opinion leaders were positive about brentuximab vedotin's potential as a treatment for Hodgkin's lymphoma Collaboration between Seattle Genetics and Millennium Pharmaceuticals will see brentuximab vedotin rapidly brought to market Datamonitor drug assessment summary for brentuximab vedotin Panobinostat (LBH589B; Novartis) Novartis is targeting a small niche indication in order to gain approval for panobinostat The Phase II data have shown that panobinostat has some activity in heavily pretreated patients Novartis has extensive experience in niche hematology indications Datamonitor drug assessment summary for panobinostat 5. Multiple Myeloma Key findings Disease overview - market potential Definition of multiple myeloma (MM) MM is a common hematological malignancy Genetic abnormalities are characteristic of multiple myeloma cells Patient segmentation Disease classification The International Staging System improves disease assessment Epidemiology Incidence of multiple myeloma will reach over 47,000 in the seven major markets by 2019 Current treatment options Treatment choice depends on transplant eligibility and patient age

6 The approval of three novel drugs has revolutionized treatment Current comparator therapies Revlimid Unmet need in multiple myeloma Drug toxicities limit disease management Optimal sequencing of drugs across different lines of therapy remains undetermined Myeloma remains incurable as disease relapse is inevitable Target product profile versus current level of attainment Revlimid's impressive trial results underlie its leading second-line status Pipeline analysis and forecasts Pipeline summary Comparative forecasts Carfilzomib (Proteolix/Onyx Pharmaceuticals) Carfilzomib is a next generation proteasome inhibitor aiming to usurp Velcade A future head-to-head study with Velcade would enhance carfilzomib's commercial potential Datamonitor drug assessment summary Panobinostat (LBH589B; Novartis) The synergistic effect between panobinostat and Velcade shown in Phase Ib trials is promising Panobinostat would face strong competition in this indication Datamonitor drug assessment summary for panobinostat Perifosine (AEterna Zentaris/Keryx Pharmaceuticals) Combination of perifosine and Velcade showed promising activity in heavily pretreated patients but further results are necessary to show the effect of perifosine Competition will make it harder to gain significant market share Datamonitor drug assessment summary Zolinza (vorinostat; Merck & Co) Phase I trial data suggest that Zolinza in combination with Velcade is active and generally well tolerated in the treatment of relapsed/refractory MM Datamonitor drug assessment summary 6. Myelodysplastic syndromes Key findings Disease overview - market potential Definition of myelodysplastic syndromes (MDS) MDS constitute a heterogeneous group of hematological malignancies Hallmark of MDS - a hypercellular bone marrow with dysplastic changes in combination with peripheral

7 cytopenias Hypercellularity Dysplasia Chromosomal abnormalities are common but little is known about the molecular basis of the disease Patient segmentation The classification of MDS French American British (FAB) System Limitations of the FAB system World Health Organization (WHO) System Limitations of the WHO classification system International Prognostic Scoring System (IPSS) The IPSS classification system is the current standard for evaluating prognosis in MDS patients Limitations of the IPSS system Epidemiology Incidence of myelodysplastic syndromes will exceed 33,000 in the seven major markets by 2019 There are limited data on the incidence of MDS Current treatment options The aim of treatment differs in lower- and higher-risk patients The choice of therapy is not solely dependent on a patient's IPSS risk group Non-chemotherapy low-intensity agents Low-intensity chemotherapy Hematopoietic stem cell transplantation (HSCT) High-intensity chemotherapy Current therapies Vidaza Unmet needs in MDS Limited pipeline activity A better understanding of the molecular pathogenesis Low-intensity therapies with improved efficacy and better toxicity profiles Target product profile versus current level of attainment Vidaza Bibliography Journals Websites Datamonitor reports Other APPENDIX Methodology Datamonitor forecast methodology Epidemiology forecasts Product forecasts Datamonitor drug assessment scorecard About Datamonitor About Datamonitor Healthcare About the Disease analysis team Datamonitor consulting Disclaimer Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.

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