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.
© MorphoSys AG © MorphoSys AG
Business Strategy
Page 3Technology
Powerful proprietary
technology platform drives
partnered programs…
and increasingly, proprietary
product development
Strong current cash-flow plus substantial
upside through milestones & royalties
Lucrative upside
Partnerships
Maturing Pipeline Illustrates Successful
Execution of Strategy
8
17
20
20
4
11
12
11
4
6
8
9
0
5
10
15
20
25
2009
2010
2011
as of today
Total
Phase 1
Phase 2
Programs
20 clinical programs ongoing
16 with seven different partners
4 proprietary, un-partnered programs
Disease areas include cancer,
inflammation, CNS, ophthalmology,
musculoskeletal, and others
© MorphoSys AG © MorphoSys AG
Strong Track Record of Technological
Innovation
HuCAL
30 commercial
partnerships
>€450 million
revenues to date
Most successful
antibody library
technology
Slonomics
Generation of
customized protein
libraries
4 deals since
acquisition
Optimization of any
therapeutic or
diagnostic antibody
arYla
Ylanthia
Next-generation
antibody library
extends technology
leadership
2012
2010
2010
2001
Page 5Slonomics:
Multiple Opportunities Beyond Antibodies
Research
&
Dx
Industrial
Enzymes
Slonomics
Rx
Proteins
e.g. Pfizer deal
(2010)
Second deal
(2012)
e.g. Novozymes
deal (2011)
e.g. Dana-Farber
alliance (2011)
© MorphoSys AG © MorphoSys AG
76 Therapeutic Antibody Programs Ongoing,
20 in Clinical Trials
Page 7
Program Partner Indication Discovery Pre-clinic Phase 1 Phase 2
MOR103 (2 programs) - Rheumatoid arthritis, Multiple sclerosis CNTO888 (2 programs) Janssen Biotech/J&J Cancer,
Idiopathic pulmonary fibrosis CNTO1959 Janssen Biotech/J&J Psoriasis
BHQ880 Novartis Cancer
BYM338 Novartis Musculoskeletal
NOV – 3 Novartis not discl.
NOV – 4 Novartis Ophthalmology
Gantenerumab Roche Alzheimer’s Disease
MOR208 - Cancer
MOR202 - Cancer
BAY94-9343 (ADC) Bayer HealthCare Cancer 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
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
NewNew in 2011/2012
New New New New New NewCurrent Pipeline
Projected HuCAL Drugs on the Market
Discovery
Preclinic
Phase 1
Phase 2
Phase 3
Market
Projection from today’s pipeline:
Source: MorphoSys internal statistics & Tufts Centre for the Study of Drug Development
50%
70%
40%
65%
Projected number of marketed HuCAL drugs from today’s pipeline: 14
4
32
Success probability of 11%
4
24
Success probability of 18%
3
11
Success probability of 25%
9
Success probability of 33%
3
© MorphoSys AG © MorphoSys AG
MOR103
New Mode of Action in Inflammation
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
Page 9
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
Phase 2 data for mavrilimumab, vs. GM-CSF
receptor, provides clinical validation of the
GM-CSF is a Key Target in the
Pathophysiology of Inflammatory Diseases
Adapted from:
© MorphoSys AG © MorphoSys AG
MOR103
European Phase 1b/2a Trial in RA
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
MOR103
European Phase 1b Trial in MS
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
© MorphoSys AG © MorphoSys AG
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
© MorphoSys AG © MorphoSys AG
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
Page 15 Non-inoculate d Vehicle MOR202 3mg/kg0.6mg/kg BOR MOR202+BOR (3+0. 6mg/kg) 0 10 20 30 40 50 60 70 80 90 100 110 % ly sis of v e hicle controlM
OR
202
/
B
OR
Bone lysis
Non -ino culate d Vehic le MOR202 3mg/kgLEN 50mg/kg MOR202+LEN (3+50mg/kg) 0 10 20 30 40 50 60 70 80 90 100 110 % ly sis of v e hic le co ntro lM
OR
202
/
L
EN
Vehic le MOR2 02 3 mg/ kg BOR 0.6mg/ kg MO R202 +BOR (3+0 .6mg/ kg) 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 n o rm a li s e d M p ro te in l e v e l Vehic le MO R202 3m g/kg LEN 50mg/k g MOR2 02+LEN (3+50mg/k g) 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 n o rm a li s e d M p ro te in l e v e lM protein
MOR202/BOR and MOR202/LEN combination
therapy is superior to the respective mono therapies
MOR202
European Phase 1/2a Trial
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)
© MorphoSys AG © MorphoSys AG
AbD Serotec Segment Complements
Therapeutic Business
Page 17
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%
© MorphoSys AG © MorphoSys AG
Institutional
Investors
46%
Retail Investors
22%
Unidentified
23%
Treasury Stock
0.7%
Management &
Supervisory Boards
1.9%
Novartis
6.4%
Balance Sheet and Shareholder Structure
Page 19
Shareholdings by Investor Type (12/2011)
Shares issued: 23,112,167 (Dec. 31, 2011)
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
Guidance 2012
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
© MorphoSys AG © MorphoSys AG
Enrollment target
nearly hit in phase 1
trial
Data in H2 2012
MOR208
Proprietary Clinical Programs to Advance
Significantly in 2012
MOR202
Phase 1/2a trial
initiated in Q3 2011
Combination arms to
start in 2013
MM
CLL
MOR103
Enrollment completed
in phase 1b/2a trial in
rheumatoid arthritis
Data in Q3 2012
MOR103
Phase 1b trial in
multiple sclerosis
initiated in Q4 2011
Data in 2013
MS
RA
SC
Page 21A Wealth of Clinical Data is Imminent
H2 2011
H1 2012
H2 2012
H1 2013
NOV – 2 (Ophthalmology)
CNTO – 1 (Inflammation)
CNTO888 (Cancer)
BYM338 (Musculoskeletal)
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.)
light colors: phase 1
dark colors: phase 2
Novartis Alliance: Landmark Deal
Timeline
May 2004: Initial deal, including equity stake
November 2007: Major expansion
November 2017: End, subject to 2-year extension option
Novartis pays…
Approx. €20m p.a. technology license including HuCAL internalization fees
Approx. €20m p.a. in research funding
Over €250m milestones (probability adjusted)
Royalties on all resulting drugs
Novartis gets…
Preferred access to HuCAL for use in over 100 discovery programs
Co-development
option
Shared costs & profits (20% – 50%) on selected co-developed programs
Excluded
Most infectious disease targets
© MorphoSys AG © MorphoSys AG
Partnerships: Typical Terms per Program
Page 25
Discovery
Preclinic
Phase 1
Phase 2
Phase 3
Market
Phase 1 milestone
Phase 3 milestone
Biologics
License
Application
+
Approval
milestones
Royalties
(mid single
digits)
Exclusive license fee; R&D funding
MorphoSys costs
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
© MorphoSys AG © MorphoSys AG
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
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
© MorphoSys AG © MorphoSys AG
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
© MorphoSys AG © MorphoSys AG
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
© MorphoSys AG © MorphoSys AG
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
Status Phase 2 (recruiting)
Study Design Randomized, double-blind, placebo-controlled study
Study Start Date August 2011 Completion Date December 2011 Enrollment 12
Primary Outcome Measures
Assessment of the affect of BYM338 on thigh muscle volume 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)
Patients 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)
Study Design Randomized, double-blind, placebo-controlled study
Study Start Date August 2011 Completion Date September 2012 Enrollment 50
Primary Outcome Measures
Increase in thigh muscle volume as measured by MRI (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 Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas
© MorphoSys AG © MorphoSys AG
Gantenerumab: Amyloid-ß Specific Antibody
in Alzheimer‘s Disease
A Study of Gantenerumab (RG1450) in Patients With Prodromal Alzheimer's Disease
Status Phase 2 (recruiting)
Study Design Randomized, double-blinded safety/efficacy study Study Start Date November 2010
Completion Date April 2015
Enrollment 360
Primary Outcome Measures
To evaluate the effect on the change in the Clinical Dementia Rating scale Sum of Boxes (CDR-SOB), a global measure of cognition and functional ability
Sub-study: Change in brain amyloid over time assessed with Positron Emission Tomography
Secondary Outcome Measures
Effect on cognition assessed with Alzheimer Disease Assessment Scale-Cognition Effect on functioning assessed with Functional Activities Questionnaire
Safety (nature and incidence of adverse events) Pharmacokinetics: gantenerumab levels
Treatment Period
Patients will be randomized to receive subcutaneous injections of either gantenerumab or placebo Patients who consent to be part of the sub-study will undergo positron emission tomography (PET)
scanning to assess brain amyloid
The anticipated time on study treatment is 104 weeks.
Group 1: 225 mg gantenerumab subcutaneous doses every 4 weeks for 104 weeks Group 2: 105 mg gantenerumab subcutaneous doses every 4 weeks for 104 weeks Group 3: Placebo
Clinical Data
In October 2011, Roche published first amyloid imaging data from Gantenerumab
The data, published in the Archives of Neurology, demonstrated a dose-dependent reduction of beta amyloid in the brain of patients treated with the monoclonal antibody, while amyloid load increased in patients on placebo
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
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March 22, 2012
Kempen Healthcare/Life Sciences Conference
Amsterdam, The Netherlands
May 4, 2012
Q1 2012 Results
May 7-9, 2012
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May 14-16, 2012
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May 15-16, 2012
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June 4-7, 2012
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