Prueba de entrada (pre-test)

company AstraZeneca, and Micromet’s MT203 is already partnered with Takeda. Clinical data generated with mavrilimumab, which was published in 2011, provided clinical validation of the targeted pathway. Several transactions in the RA area in recent years un- derline the interest of pharmaceutical companies in novel biological treatments.

MOR103 has the potential to be first in class among anti-GM-CSF

antibodies. Other advanced programs in development are MedIm-

mune’s mavrilimumab (CAM-3001), a human monoclonal antibody

targeting the GM-CSF receptor, which is currently being evaluated in a phase 2 clinical trial, and Micromet’s MT203, another human

antibody against GM-CSF. MedImmune is part of pharmaceutical

tab. 3: MarKEt data on sElEc tEd partnErEd prograMs in clinical phasE 2

program name Morphosys partner indication Market potential

Gantenerumab Roche Alzheimer’s Disease (AD) – High unmet medical need due to lack of disease- modifying drugs

– High potential market growth rate due to aging population, earlier and improved diagnosis and the emergence of accompanying immunotherapies that will be prescribed in addition to existing treatments

– Expected CAGR over the next few years: 10.7 %, with a total market size of around US$ 11.8 billion in 2018 BHQ 880 Novartis Multiple Myeloma (MM) – Most frequent cancer affecting the skeleton

– Reversing bone destruction is a major issue in myeloma treatment – BHQ880 could help restore bone formation – Market will be increasingly saturated with effective

treatments; development opportunities lie in improve- ment of survival rates and reduced toxicities – Market size will nearly double over the next few years

to around US$ 5.3 billion in 2018 CNTO888 Janssen Biotech Idiopathic Pulmonary

Fibrosis (IPF)

– Most common interstitial lung disease, with 100,000 patients and more than 30,000 new cases per year in the USA alone

– Significant unmet medical need: IPF is still a uniformly fatal disease, with an estimated median survival time of two to five years

– Only one approved drug (Esbriet) for IPF so far – Market is expected to grow extremely strongly – at a

CAGR of 50.2 % over the next few years to reach a total size of around US$ 1.9 billion in 2018

Source: Datamonitor, GlobalData, The Pharma Letter

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Regarding the MS market, many disease-modifying treatments are quite cost-intensive. Biologics already represent the largest class of disease-modifying therapies, both by sales and by number of approved therapies. The current top-selling MS drugs generate combined annual sales of about US$ 11 billion and the market is expected to grow. Following a period in which biologics trans- formed the MS market, the small molecules segment, which cur- rently makes up more than 30 % of the market, is expected to see a renaissance in the next three to four years. However, differences in course and severity of MS result in a large segmentation with various subtypes, i.e. relapsing/remitting forms, primary and sec- ondary progressive forms, etc., which offers different entry routes for new therapeutic agents.

Over the next couple of years, a new class of oral drugs, known as JAK inhibitors, is expected to contribute significantly to the anti- inflammatory market. JAK inhibitors block the action of proteins called Janus-associated kinases which are involved in cell-signal- ing. The first JAK inhibitor for rheumatoid arthritis, Pfizer’s tofaci- tinib, is expected to gain approval by the FDA in 2012.

INFECTIOUS DISE ASES

MorphoSys initiated an early infectious disease program against drug-resistant MRSA (methicillin-resistant S. aureus) infections in 2010. As part of this initiative, MorphoSys signed a license and collaboration agreement with UK-based Absynth Biologics, provid- ing access to novel target molecules associated with Staphylococ­

cus aureus infections, including MRSA. MorphoSys generated anti-

bodies using its proprietary HuCALPLATINUMantibody library.

These antibodies are currently being further validated. MorphoSys will be solely responsible for the development and partnering of the resulting compounds.

Hospital-acquired or nosocomial infections are a growing public health concern and are associated with increasing levels of mortal- ity. The Centers for Disease Control and Prevention estimates that, in the United States alone, about 1.7 million nosocomial infections and 99,000 associated deaths occur each year. These infections

are caused by microorganisms including drug-resistant MRSA. In

the United Kingdom, S. aureus accounts for almost half of all hos- pital-acquired infections.

ONCOLOGY

The ability of monoclonal antibodies to bind to specific antigens has led to their dominant position in the area of targeted cancer therapies, and the global market for innovative biological therapies in cancer treatment is constantly growing at a very high speed. More precisely, the biotherapy segment is forecast to almost double in size by 2014, eventually exceeding US$ 50 billion in the next five to ten years, according to BCC Research.

MorphoSys has advanced two proprietary cancer programs, namely

MOR202 and MOR208, into clinical development in the last two

years. MorphoSys’s antibody MOR208 is currently undergoing a

clinical phase 1 study against chronic lymphocytic leukemia (CLL). Its immunotherapeutic target, CD19, is of particular interest for many B-cell-derived cancers. The therapeutic market for B-cell malignancies is about US$ 4 – 5 billion according to research firm Decision Resources. Existing biologics therapies against B-cell malignancies, including the blockbuster product Rituxan®_{, target}

the cell marker CD20. Due to the target molecule being expressed on a broader range of B-cell subsets – compared to CD20 – anti- CD19 antibodies are considered to be potentially more effective. In addition, MOR208 is also improved by a modification of the con- stant Fc-part of the antibody, leading to increased cellular cyto- toxicity (ADCC).

From a commercial perspective, the market for B-cell cancer therapies is promising due to the need for alternative and more effective treatment options. The current competitive landscape in this area is marked by efforts towards technological improve- ments, and better efficacy and safety profiles. The most advanced competitive anti-CD19 antibody is Micromet’s BiTE antibody blina- tumomab (MT103), which is currently being evaluated in phase 2 studies in acute lymphoblastic leukemia (ALL). Other clinical pro- grams against the same target are pursued by, among others, AstraZeneca/MedImmune and Sanofi/Immunogen.

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