MOR106

a new antibody in development
for atopic dermatitis

MOR208

an investigational antibody
for blood cancer

Anetumab
ravtansine

A drug candidate for mesothelioma

Guselkumab

An antibody developed by
Janssen Research & Development, LLC
based on MorphoSys’s HuCAL
antibody library

Annual Report 2016

Engineering the Medicines
of Tomorrow

MOR106
MOR208
ANETUMAB RAVTANSINE
GUSELKUMAB

Phase 3

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The compound:
Guselkumab – An investigational antibody targeting IL-23

The investigational antibody guselkumab, developed by Janssen Research & Development, LLC (Janssen), could become the first antibody based on MorphoSys’s technology to reach the market.

Guselkumab is a fully human anti-interleukin (IL)-23 monoclonal antibody developed by Janssen. The HuCAL antibody library technology was used to generate the guselkumab antibody under license from MorphoSys. IL-23 is a pro-inflammatory protein which has been identified as a cytokine in autoimmune diseases. According to scientific literature, IL-23 is found in the skin of patients with psoriasis and in other inflammatory diseases. It is therefore considered a potential treatment target for inflammatory diseases.

Guselkumab is being developed by MorphoSys’s licensee Janssen for the treatment of moderate to severe plaque psoriasis and for patients with active psoriatic arthritis (PsA). In November 2016, Janssen announced the submission of regulatory filings to the FDA and EMA seeking approval for guselkumab in adult patients with moderate to severe plaque psoriasis.

  1. General image formation of psoriasis
  1. USUALLY LOCATED AT LARGE JOINTS Plaques Epidermis Dermis PERSISTENT SECRETION OF PRO-INFLAMMATORY CYTOKINES ABNORMAL GROWTH OF SKIN CELLS (KERATINOCYTE GROWTH INCREASED 8-FOLD) KERATINOCYTES
    Psoriasis is characterized by an abnormally excessive and rapid growth of skin cells in the epidermal layer of the skin. Skin cells have been observed to be replaced every 3–5 days in psoriasis rather than the usual 28–30 days. These changes are believed to stem from a premature maturation of keratinocytes which accumulate at the skin surface and form red and scaly patches of skin. This process is assumed to be induced by an inflammatory cascade in the dermis involving various types of immune cells. These immune cells move from the dermis to the epidermis and secrete (send out) pro-inflammatory cytokines (chemical signals) which are believed to stimulate keratinocytes to proliferate. By blocking these cytokines, it is intended to treat psoriasis.

The therapeutic field: Targeting psoriasis

Psoriasis is an inflammatory autoimmune disease of the skin. These inflamed skin patches may vary in severity from small and localized to complete body coverage. There are five main types of psoriasis: plaque, guttate, inverse, pustular, and erythrodermic. Plaque psoriasis, also known as psoriasis vulgaris, makes up about 90% of cases. It typically presents with red, itchy and scaly patches with white scales on top (plaques). Psoriasis is usually chronic and has a high morbidity and negative impact on patients’ quality of life. In 2015 prevalence of the disease was 16 million patients in the seven major countries (USA, Japan, France, Germany, Italy, Spain, and Great Britain), as estimated by independent market experts.

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Interview

Dr. Markus EnzelbergerHead of Discovery Alliances & Technologies, MorphoSys

Dr. Enzelberger, in October 2016 MorphoSys licensee Janssen announced positive phase 3 data with the HuCAL antibody guselkumab in psoriasis. What did Janssen report?
Janssen reported results from its phase 3 clinical VOYAGE-1 trial in 837 patients with moderate to severe plaque psoriasis. In the study, the efficacy and safety of guselkumab were compared with placebo and with the psoriasis drug adalimumab. The data presented by Janssen showed that guselkumab exhibited significantly better efficacy than placebo and superiority over adalimumab. According to Janssen the study met both the primary endpoints and all major secondary endpoints.
How was efficacy measured in the trial?
For the primary endpoints, it was assessed whether signs and symptoms of psoriasis were improved, while delivering clear or almost clear skin (IGA 0 or 1 and PASI 90) at week 16, in patients receiving guselkumab compared to those receiving placebo. An IGA (“investigator global assessment”) score of 0 or 1 means a patient has either achieved completely clear skin (IGA 0) or almost completely clear skin (IGA 1). PASI 90 means that 90% of the psoriatic lesions have disappeared. For the secondary endpoints it was assessed in what percentage of patients the signs and symptoms of psoriasis were improved under the treatment with guselkumab compared to patients receiving adalimumab.
In November 2016 Janssen announced that it submitted regulatory filings to both FDA and EMA, seeking market approval for guselkumab for the treatment of patients with moderate to severe plaque psoriasis. What does this mean to MorphoSys?
This means a lot. If approval is granted, guselkumab could become the first marketed antibody based on MorphoSys’s proprietary antibody technology. This would be fantastic and extremely rewarding for the entire MorphoSys team who worked on this project. We hope this therapy will be made available, benefitting patients living with moderate to severe plaque psoriasis.
If approval is granted, how would MorphoSys benefit?
We will be entitled to a milestone payment and royalties. We hope that, with the partnered pipeline expected to mature over the coming years, we can generate a growing revenue stream from royalties in the future which we can then reinvest in the development of our proprietary pipeline.
What is the estimated sales potential for guselkumab in this indication?
It is too early to give an answer to this question. According to independent market experts the total market for psoriasis is expected to grow from USD 7.4 billion in 2014 to nearly USD 12 billion in 2024.
In late 2016, Janssen reported positive phase 2 data for guselkumab in a second indication, psoriatic arthritis (PsA).
We were very pleased about that. According to Janssen, a substantially higher percentage of PsA patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of the disease (the ACR20 parameter, the study's primary endpoint), compared with patients receiving placebo. Janssen has already announced plans to start a phase 3 program with guselkumab in this indication. We look forward to this development by our partner.

as of March 2017

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