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MorphoSys AG — Investor Presentation 2012
Mar 26, 2012
291_ip_2012-03-26_e8437381-ac98-463e-baaf-97dd965f4a6a.pdf
Investor Presentation
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Company Update
March 2012
This presentation includes forward-looking statements.
Actual results could differ materially from those included in the forward-looking statements due to various risk factors and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing.
These and other risks and uncertainties are detailed in the Company's Annual Report.
Maturing Pipeline Illustrates Successful Execution of Strategy
Total Phase 1 Phase 2
- 16 with seven different partners
- 4 proprietary, un-partnered programs
- Disease areas include cancer, inflammation, CNS, ophthalmology, musculoskeletal, and others
Strong Track Record of Technological Innovation
Slonomics: Multiple Opportunities Beyond Antibodies
76 Therapeutic Antibody Programs Ongoing, 20 in Clinical Trials
| Program | Partner | Indication | Discovery | Pre-clinic | Phase 1 | Phase 2 |
|---|---|---|---|---|---|---|
| MOR103 (2 programs) - |
Rheumatoid arthritis, Multiple sclerosis |
New | ||||
| CNTO888 (2 programs) | Janssen Biotech/J&J |
Cancer, Idiopathic pulmonary fibrosis |
||||
| CNTO1959 | Janssen Biotech/J&J |
Psoriasis | New | |||
| BHQ880 | Novartis | Cancer | ||||
| BYM338 | Novartis | Musculoskeletal | New | |||
| NOV – 3 |
Novartis | not discl. | ||||
| NOV – 4 |
Novartis | Ophthalmology | New | |||
| Gantenerumab | Roche | Alzheimer's Disease | ||||
| MOR208 | - | Cancer | ||||
| MOR202 | - | Cancer | New | |||
| BAY94-9343 (ADC) Bayer HealthCare |
Cancer | New | ||||
| BI – 1 Boehringer Ingelheim |
not discl. | |||||
| CNTO3157 Janssen Biotech/J&J |
Asthma | |||||
| CNTO – 5 |
Janssen Biotech/J&J |
Inflammation | ||||
| NOV – 5 |
Novartis | Inflammation | ||||
| OMP-18R5 | Oncomed | Cancer | New | |||
| OMP-59R5 Oncomed |
Cancer | |||||
| PFE – 1 |
Pfizer | Cancer | ||||
| 24 Partnered Programs | Various Partners | Various Indications | ||||
| 32 Programs, incl. 2 co-dev with Novartis |
Various Partners | Various Indications | 68 Partnered Programs 8 Proprietary Programs |
New in 2011/2012
Page 7
Current Pipeline Projected HuCAL Drugs on the Market
Source: MorphoSys internal statistics & Tufts Centre for the Study of Drug Development
The Drug
Ultra-high affinity HuCAL IgG1 targeting GM-CSF
Market
- Large commercial potential in inflammatory conditions including RA, MS, & others
- Revenues with approved biologics in RA in 2010 exceeded USD15bn
Intellectual Property
- Exclusive license to a US patent covering anti-GM-CSF antibodies for the treatment of chronic inflammatory conditions
- US patent on MOR103 composition of matter
Development
- European phase 1b/2a trial in RA fully recruited, data expected Q3 2012
- Ph1b safety study in MS patients initiated in Q4/11
- PK study for sc administration initiated in Q1/12
Phase 2 data for mavrilimumab, vs. GM-CSF receptor, provides clinical validation of the pathway in rheumatoid arthritis
Proportion of subjects achieving a change of 1.2 from baseline in DAS28-CRP
Source: ACR2011 Abstract: Mavrilimumab (an Anti-GM-CSFRα Monoclonal Antibody) in Subjects with Rheumatoid Arthritis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study
http://acr.confex.com/acr/2011/webprogram/Paper24567.html
GM-CSF is a Key Target in the Pathophysiology of Inflammatory Diseases
Adapted from: Hamilton JA, (2008) Nat Rev Immunol. 8:533-44
| Trial | A Study of the safety and preliminary efficacy of MOR103, a human antibody to granulocyte macrophage colony-stimulating factor (GM-CSF) |
||||
|---|---|---|---|---|---|
| Patients | Patients with active rheumatoid arthritis | ||||
| Study Design | Randomized, double-blind, placebo-controlled, multi-center dose-escalation study (three groups with 0.3/1.0/1.5 mg/kg) of MOR103 on background of stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs) |
||||
| Primary Endpoint | Adverse event rate and safety profile | ||||
| Secondary Endpoints | DAS28, ACR core set measures and EULAR28 response criteria, hematology, blood chemistry, Ig levels, cytokines, synovitis, bone edema |
||||
| Study Details | 96 patients Sites in Germany, The Netherlands, Bulgaria, Poland, Ukraine Inclusion of MRI to detect an effect on inflammatory changes such as synovitis or bone edema Results in Q3 2012 |
| Trial | Phase Ib study to evaluate the safety and pharmacokinetics of MOR103, a human antibody to GM-CSF, in patients with multiple sclerosis (MS) |
||||
|---|---|---|---|---|---|
| Patients | Patients with relapsing-remitting or secondary progressive MS (RRMS or SPMS) |
||||
| Study Design | A randomized, double-blind, placebo-controlled study (three groups with 0.5/1.0/2.0 mg/kg; 6 doses) to evaluate the safety and pharmacokinetics of MOR103, a human antibody to GM-CSF, in patients with multiple sclerosis |
||||
| Primary Endpoint | Incidence and severity of adverse events | ||||
| Secondary Endpoints | Pharmacokinetic profile Potential immunogenicity |
||||
| Study Details | 30 patients Sites in Germany, Poland, UK Results expected in 2013 |
MOR208 (XmAb5574) – A Novel High-Potential Anti-Cancer Antibody
The Drug
- Humanized, high affinity anti-CD19 antibody, exclusive license from Xencor
- Comprises a proprietary Xencor modification leading to rapid and sustained B-cell depletion
Market
High unmet medical need in NHL, CLL & ALL
Competitive Profile
- Expect convenient dosing schedule
- Straightforward manufacturing
- Potential for good safety profile
- Significantly increased ADCC compared to rituximab in vitro
Development
- Completion of phase 1 in CLL and reporting of interim data H2/12
- Initiation of additional trials in B cell malignancies in 2012
MOR208 (XmAb5574) Phase 1 Trial in the US
| Trial | Safety and tolerability of MOR208 (XmAb5574) in Chronic Lymphocytic Leukemia | ||||
|---|---|---|---|---|---|
| Patients | Patients with relapsed or refractory CLL/SLL | ||||
| Study Design | MOR208/XmAb5574 (humanized, Fc-engineered, anti-CD19 IgG1 antibody) Open-label, multi-dose, single-arm, Phase 1, dose-escalation study |
||||
| Primary Endpoint | To determine the dose limiting toxicities (time frame 28 days) | ||||
| Study Details | 30 patients Identification of the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study Characterization of safety and tolerability, PK, PD and immunogenicity Evaluation of preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL Study sponsored by Xencor, Inc. |
MOR202 – A Novel High-Potential Antibody for Multiple Myeloma
The Drug
High affinity HuCAL antibody targeting CD38
The Market
- High unmet medical need in MM, accounting for approximately 1% of all cancers.
- Median survival is approximately 3-5 years
Competitive Profile
- Use of targeted therapy in combination with standard regimens in myeloma can minimize adverse events while increasing efficacy
- MOR202 monotherapy shows a dose-dependent reduction of multiple myeloma graft induced bone lysis (pre-clinical studies)
- MOR202 plus bortezomib or lenalidomide synergistically inhibits bone lysis and substantially reduces M protein levels (pre-clinical studies)
Development
Study to last until January 2015, interim reporting planned
MOR202/BOR and MOR202/LEN combination therapy is superior to the respective mono therapies
| Trial | A phase I/IIa, open-label, multicentre, dose-escalation study to evaluate the safety and preliminary efficacy of the human anti-CD38 antibody MOR202 as monotherapy and in combination with standard therapy in subjects with relapsed/refractory multiple myeloma |
|---|---|
| Patients | Patients relapsed/refractory multiple myeloma; failure of at least 2 prior therapies |
| Study Design | • MOR202 (anti-CD38 HuCAL IgG1 antibody) • Phase I dose escalation (iv administration of MOR202 for up to 2 cycles) • Phase IIa monotherapy extension (iv administration of MOR202 for up to 4 cycles) • Phase Ib MOR202 combined with bortezomib • Phase Ib MOR202 combined with lenalidomide |
| Primary Endpoint |
• Determination of MTD and / or recommended dose (up to 20 weeks) • Safety & immunogenicity |
| Secondary Endpoints |
• Pharmacokinetics of MOR202 • Overall response rate (standard response criteria, serum M protein levels) |
| Study Details | • Up to 82 patients • Study sites in Germany & Austria |
AbD Serotec Segment Complements Therapeutic Business
| Research Activities |
|---|
- Catalogue of 15,000+ products
- Stable and recurring cash flows
- Customers comprise universities, government bodies, life science companies
- Website, eCommerce
HuCAL – Diagnostic Applications
- Custom antibody generation
- Using proprietary technologies to deliver superior Dx antibodies
- Future upside via royalties
- Collaborations with more than 20 diagnostics companies
FY2011: Income Statement
| in € million |
2011 | 2010 | Change | |
|---|---|---|---|---|
| Revenues | 100.8 | 87.0 | +16% | |
| Cost of Goods Sold | 7.0 | 7.3 | ||
| Total Research and Development Expenses | 57.5 | 46.9 | ||
| Sales, General & Administrative Expenses | 24.6 | 23.2 | ||
| Total Operating Expenses | 89.1 | 77.4 | +15% | |
| Other Operating Income | 0.5 | 0.2 | ||
| Profit from Operations | 12.2 | 9.8 | +24% | |
| Finance Income | 1.4 | 4.1 | ||
| Other Expenses | 2.1 | 0.8 | ||
| Profit before Taxes | 11.4 | 13.2 | -14% | |
| Income Tax Expenses | 3.2 | 4.0 | ||
| Net Profit | 8.2 | 9.2 | -11% | |
| EPS (diluted) | 0.36 | 0.40 |
| Balance Sheet | ||||||
|---|---|---|---|---|---|---|
| EUR millions | Dec. 31, 2011 |
Dec. 31, 2010 |
||||
| Assets | ||||||
| Cash, Cash Equivalents & Marketable Securities |
134.4 | 108.4 | ||||
| Other Current Assets | 20.3 | 24.1 | ||||
| Total Non-Current Assets | 73.7 | 77.3 | ||||
| Total Assets | 228.4 | 209.8 | ||||
| Liabilities | ||||||
| Total Current Liabilities | 23.8 | 21.4 | ||||
| Total Non-Current Liabilities | 7.5 | 2.5 | ||||
| Total Shareholders' Equity | 197.1 | 185.9 | ||||
| Total Liabilities | 228.4 | 209.8 |
Shareholdings by Investor Type (12/2011)
| in € million |
2012 | 2011 |
|---|---|---|
| Group Revenues | 75 – 80 |
100.8 |
| Investment into Proprietary R&D | 20 – 25 |
36.7 |
| Group EBIT | 1 – 5 |
11.1 |
| in € million |
2012 | 2011 | |
|---|---|---|---|
| AbD Serotec Segment Revenues (at constant currency) |
20 – 22 |
19.3 | |
| AbD Serotec EBIT Margin (at constant currency) |
~ 6% – 8% |
5% |
Proprietary Clinical Programs to Advance Significantly in 2012
A Wealth of Clinical Data is Imminent
| H2 2011 | H1 2012 | H2 2012 | H1 2013 | |
|---|---|---|---|---|
| NOV – 2 (Ophthalmology) |
||||
| CNTO – 1 (Inflammation) |
light colors: phase 1 |
|||
| CNTO888 (Cancer) |
dark colors: phase 2 |
|||
| BYM338 (Musculoskeletal) |
PoC in 2012 |
|||
| CNTO3157 (Asthma) |
||||
| MOR208 (CLL) |
||||
| BHQ880 (Cancer) |
||||
| CNTO888 (IPF) |
||||
| OMP18-R5 (Cancer) |
||||
| OMP59-R5 (Cancer) |
||||
| MOR103 (RA) |
||||
| BYM338 (Musculoskeletal) |
||||
| NOV – 3 (n.d.) |
||||
| NOV – 3 (n.d.) |
||||
| NOV – 4 (Ophthalmology) |
||||
| PFE – 1 (Cancer) |
||||
| CNTO1959 (Psoriasis) | ||||
| BI – 1 (n.d.) |
||||
| BHQ880 (Cancer) | ||||
| NOV – 4 (Ophthalmology) |
||||
| NOV – 4 (Ophthalmology) |
||||
| NOV – 3 (n.d.) |
Appendix
Novartis Alliance: Landmark Deal
Partnerships: Typical Terms per Program
Partnered Programs Phase 2 Clinical Development
| Program | Partner | Disease | Target | Status |
|---|---|---|---|---|
| CNTO888 | Janssen Biotech |
Oncology | CCL2 (MCP-1) |
Two trials ongoing, one trial completed |
| CNTO888 | Janssen Biotech |
Idiopathic pulmonary fibrosis |
CCL2 (MCP-1) |
Novel approach to IPF |
| CNTO1959 | Janssen Biotech |
Psoriasis | IL23p19 | Phase 2 trial started in December 2011 |
| n.d. | Novartis | n.d. | n.d. | Clinical proof of concept achieved |
| n.d. | Novartis | Ophthalmology | n.d. | Phase 2 trial started in January 2012 |
| BHQ880 | Novartis | Osteolytic bone disease |
DKK-1 | Early data show stimulation of bone formation |
| BYM338 | Novartis | Musculoskeletal | n.d. | Two phase 2 trials ongoing |
| Gantenerumab | Roche | Alzheimer's disease |
Amyloid-b | Only anti-Aβ antibody being developed in patients with prodromal AD |
Partnered Programs Phase 1 Clinical Development
| Program | Partner | Disease | Phase 1 Start |
|---|---|---|---|
| BAY94-9343 | Bayer | Oncology | September 2011 |
| n.d. | Boehringer Ingelheim |
n.d. | December 2010 |
| CNTO3157 | Janssen Biotech | Asthma | June 2010 |
| n.d. | Janssen Biotech | Inflammation / Autoimmune | December 2010 |
| n.d. | Novartis | Inflammation | December 2010 |
| OMP-18R5 | Oncomed | Oncology | April 2011 |
| OMP-59R5 | Oncomed | Oncology | December 2010 |
| n.d. | Pfizer | Oncology | December 2010 |
Carlumab (CNTO 888): CCL2 Specific Antibody in Oncology
A Study of the Safety and Efficacy of CNTO 888 in Combination With Standard of Care Chemotherapy in Patients With Solid Tumors
| Status | Phase 1 (completed) | |||
|---|---|---|---|---|
| Study Design | Non-randomized, open-label safety study | |||
| Study Start Date | May 2010 | |||
| Completion Date |
n.d. | |||
| Enrollment | 53 | |||
| Primary Outcome Measures |
The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens (docetaxel; gemcitabine; Paclitaxel and carboplatin; or DOXIL®/ Caelyx® doxorubicin HCl liposome injection) |
|||
| Secondary Outcome Measures |
Pharmacokinetics [during study as specified in the protocol and at End of Study (1 year)] Pharmacodynamics [during study as specified in the protocol and at End of Study (1 year)] |
|||
| Treatment Period |
Combination therapy will be continued until disease progression, unacceptable toxicity, the patient refuses further combination therapy, withdraws consent, or is treated for 1 year |
Period |
A Study of the Safety and Efficacy of Single-agent CNTO 888 (an Anti CC-Chemokine Ligand 2 [CCL2]) in Patients With Metastatic Prostate Cancer
| Status Phase 2 (completed) |
||
|---|---|---|
| Study Design | Non-randomized, open-label safety/efficacy study |
|
| Study Start Date September 2009 |
||
| Completion Date July 2011 |
||
| Enrollment | 46 | |
| Primary Outcome Measures |
The primary objective of the study is to determine the composite response in patients with metastatic castrate-resistant prostate cancer (CRPC) who receive single-agent 15 mg/kg CNTO 888 every 2 weeks (Time Frame: 3-6 months) |
|
| Secondary Outcome Measures |
Objective response rate determined as complete response and partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines Progression Free Survival Overall Survival |
|
| Treatment Period |
15mg/kg intravenously every 2 weeks until disease progression |
Carlumab (CNTO 888): CCL2 Specific Antibody in Idiopathic Pulmonary Fibrosis
A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
| Status | Phase 2 (active, not recruiting) |
|---|---|
| Study Design | Randomized, double-blinded safety/efficacy study |
| Study Start Date | December 2008 |
| Completion Date |
June 2012 |
| Enrollment | 129 |
| Primary Outcome Measures |
The primary objective is to determine the efficacy (as measured by pulmonary function) and safety of CNTO 888 in subjects with IPF. |
| Secondary Outcome Measures |
To assess the effect of CNTO888 on measures of disease progression, patient reported outcomes, functional capacity and health-related quality of life, and to assess the pharmacokinetics/ pharmaco dynamics of CNTO888 in subjects with IPF. |
| Treatment Period | Patients will receive study agent until Week 48 and will continue to be followed through Week 72 for assessment of safety and any other effects after discontinuation of therapy. Patients will be in the study for about 74 weeks. Group 1: placebo Group 2: 1 g/kg CNTO888 every 4 weeks Group 3: 5mg/kg CNTO888 every 4 weeks Group 4: 15 mg/kg CNTO888 every 4 weeks |
CNTO1959: HuCAL Antibody for the Treatment of Patients with Psoriasis
| A Study to Evaluate CNTO 1959 in the Treatment of Patients |
|---|
| With Moderate to Severe Plaque-type Psoriasis (X-PLORE) |
| Status | Phase 2 (recruiting) | |
|---|---|---|
| Study Design | Randomized, double-blind, placebo-controlled study |
|
| Study Start Date | October 2011 | |
| Completion Date |
February 2014 | |
| Enrollment | 280 | |
| Primary Outcome Measures |
Physician's Global Assessment (PGA) score of cleared or minimal (Time Frame: Week 16); Overall assessment of induration, scaling, and erythema |
|
| Secondary Outcome Measures |
Psoriasis Area and Severity Index (PASI) 75% or greater improvement from baseline (Time Frame: Week 16) The difference in the PGA score of cleared (0) or minimal (1) response rate between CNTO 1959 treatment groups and adalimumab treat ment group (Time Frame: Weeks 16 and 40) The change from baseline in Dermatology Life Quality Index (DLQI) (Time Frame: Week 16) |
|
| Treatment | 5 groups: CNTO 1959 (5 mg / 15 mg / 50 mg / 100 mg / 200 mg Drug: Adalimumab Drug: Placebo to CNTO 1959 (100 mg) |
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 Following a Single SC Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis
| Status | Phase 1 (recruiting) |
|---|---|
| Study Design | Randomized, double-blind, placebo-controlled study |
| Study Start Date | August 2011 |
| Completion Date |
June 2013 |
| Enrollment | 32 |
| Primary Outcome Measures |
The number and type of adverse events Change in clinical laboratory values Electrocardiogram Changes or abnormalities in body systems Axillary temperature Pulse rate Blood pressure (Time Frame: Up to 24 weeks) |
| Secondary Outcome Measures |
Blood levels of CNTO 1959 Antibodies to CNTO 1959 Psoriasis Area and Severity Index (PASI) Physician's Global Assessment (PGA) |
| Treatment | Drug: CNTO 1959 (10mg, 30mg, 100mg, 300mg, subcutaneous use, ascending dosing for 24 weeks Drug: Placebo |
BHQ880: DKK-1 Specific Antibody in Multiple Myeloma Associated Osteolysis
A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients
| Status | Phase 1/2 (active, not recruiting) |
|---|---|
| Study Design | Randomized, double-blinded safety/efficacy study |
| Study Start Date | January 2009 |
| Completion Date |
April 2012 |
| Enrollment | 267 |
| Primary Outcome Measures | Time to first SRE and change in bone markers for bone resorption and formation (Time Frame: 9 months minimum treatment with BHQ880 or placebo in combination with zoledronic acid and standard anti-myeloma therapy |
| Secondary Outcome Measures | Characterize acute and chronic safety and tolerability of BHQ880 Characterize single-dose and repeated-dose pharmacokinetic profiles of BHQ880 Assess the potential immunogenicity of BHQ880 Characterize the binding kinetics of DKK1/BHQ880 complex (free&BHQ880 bound DKK1) in serum Determine the pharmacodynamic effects of BHQ880 by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine |
| Treatment Period | Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid Group 1: Various intravenous doses (low) of BHQ880 (up to 20 mg/kg) in combination with zoledronic acid on day 1 of a 28-day cycle. Goup 2: Various intravenous doses (medium) of BHQ880 (up to 20 mg/kg) in combination with zoledronic acid on day 1 of a 28-day cycle. Group 3: Various intravenous doses (high) of BHQ880 (up to 20 mg/kg) in combination with zoledronic acid on day 1 of a 28-day cycle. Group 4: Placebo in combination with zoledronic acid on day 1 of a 28-day cycle |
BHQ880: DKK-1 Specific Antibody in Multiple Myeloma Associated Osteolysis
Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
| Status | Phase 2 (recruiting) |
|---|---|
| Study Design | Non-randomized, open-label study |
| Study Start Date | May 2011 |
| Completion Date |
March 2013 |
| Enrollment | 40 |
| Primary Outcome Measures | Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A (Time frame: at 6 months) |
| Secondary Outcome Measures | Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values (Time frame: From start of study until disease progression ) Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma (Time frame: Throughout the study until disease progression) Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers (Time frame: Throughout the study until disease progression) Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT (Time frame: 6 months and 12 months) |
| Treatment Period | This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma BHQ880 will be administered every 28 days in previously untreated patients. Single arm |
BHQ880: DKK-1 Specific Antibody in Multiple Myeloma Associated Osteolysis
| Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency | ||
|---|---|---|
| Status | Phase 2 (recruiting) | |
| Study Design | Randomized, double-blinded study |
|
| Study Start Date | May 2011 | |
| Completion Date |
February 2016 |
|
| Enrollment | 144 | |
| Primary Outcome Measures | Effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone (Time Frame: 18-month median time to first SRE assumed for the placebo arm) |
|
| Secondary Outcome Measures | Safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib (Determine the pharmacokinetic parameters for BHQ880 and bortezomib. Evaluate the effect of BHQ880 on bone metabolism 1) Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA), 2) Change in bone strength, measured by quantitative computed tomography (qCT), Determine the anti-myeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone 1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880 |
|
| Treatment Period | The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study. |
BYM338: HuCAL Antibody for the Unintentional Weight Loss in Cancer Patients
| Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis |
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas |
||
|---|---|---|---|
| Status | Phase 2 (recruiting) | Status | Phase 2 (recruiting) |
| Study Design | Randomized, double-blind, placebo-controlled study |
Study Design | Randomized, double-blind, placebo-controlled study |
| Study Start Date | August 2011 | Study Start Date | August 2011 |
| Completion Date |
December 2011 |
Completion Date |
September 2012 |
| Enrollment | 12 | Enrollment | 50 |
| Primary Outcome Measures |
Assessment of the affect of BYM338 on thigh muscle volume by MRI (time frame: 8 weeks) |
Primary Outcome Measures |
Increase in thigh muscle volume as measured by MRI (Time Frame: 8 Weeks) |
| Secondary Outcome Measures |
Assessment of the effect of BYM338 on muscle function by 'Timed Get Up and Go' test (Time frame: 8 weeks) |
Secondary Outcome Measures |
6 minute walk test (Time frame: 8 weeks) Efficacy in treating unintentional weight loss (Time frame: 8 weeks) Obtain pharmacokinetic data in this population (Time frame: 8 weeks) Efficacy in improving total lean body mass (LBM) and total bone mineral content (Time frame: 8 weeks) Improving physical activity and function (Time frame: 8 weeks) |
| Patients | Patients with sporadic Inclusion Body Myositis | Patients | Patients With Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas |
Gantenerumab: Amyloid-ß Specific Antibody in Alzheimer's Disease
Management Team
Dr. Simon E. Moroney, CEO
- Co-founder, previously at ImmunoGen
- German Cross of the Order of Merit (2002), Bavarian State Medal for Outstanding Services to the Bavarian Economy (2009)
Jens Holstein, CFO
- Joined MorphoSys in 2011
- Formerly at Fresenius: Regional CFO for region EME of Fresenius Kabi AG; several financial and general management positions at Fresenius; and in consulting industry
Dr. Arndt Schottelius, CDO
- Joined MorphoSys in 2008
- Formerly Medical Director in Immunology at Genentech Inc.; Berlex Biosciences, USA; Schering, Germany; Charité University Hospital, Berlin
Dr. Marlies Sproll, CSO
- Joined MorphoSys in 2000, promoted to CSO in 2005
- Formerly at Boehringer Ingelheim in Vienna; Merck KGaA in Darmstadt
| Contact | |
|---|---|
| Covering Analysts |
| Close Brother Seydler | Mr. Igor Kim |
|---|---|
| Commerzbank | Mr. Daniel Wendorff |
| Deutsche Bank | Mr. Gunnar Romer |
| DZ Bank | Dr. Elmar Kraus |
| Edison | Dr. Mick Cooper |
| Equinet Institutional Services |
Edouard Aubéry |
| Helvea | Dr. Olav Zilian |
| Kempen & Co. | Mr. Sachin Soni / Mr. Mark Pospisilik |
| Landesbank Baden-Württemberg | Mr. Timo Kürschner |
| Nomura Code | Dr. Gary Waanders |
| WestLB AG | Dr. Cornelia Thomas / Mr. Oliver Kaemmerer |
Upcoming Events & Conferences
| March 22, 2012 |
Kempen Healthcare/Life Sciences Conference Amsterdam, The Netherlands |
|---|---|
| May 4, 2012 |
Q1 2012 Results |
| | Deutsche Bank Health Care Conference |
| May 7-9, 2012 | Boston, USA |
| | German Swiss & Austrian Conference 2012 |
| May 14-16, 2012 | Frankfurt, Germany |
| May 15-16, 2012 |
BioEquity, Frankfurt, Germany |
| | Jefferies 2012 Global Healthcare Conference |
| June 4-7, 2012 | New York, USA |
For more information please visit www.morphosys.com
Thank You
www.morphosys.com
Dr. Simon Moroney
Chief Executive Officer
Phone +49 (0)89 / 899 27-311 Fax +49 (0)89 / 899 27-5311 Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR
Phone +49 (0)89 / 899 27-122 Fax +49 (0)89 / 899 27-5122 Email [email protected]
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, Ylanthia®, arYla®, CysDisplay®, RapMAT® and AutoCAL® are registered trademarks of MorphoSys AG. Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.