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Tremfya™ (Guselkumab)

The investigational antibody Tremfya™ (guselkumab), developed by Janssen Research & Development, LLC (Janssen), is the first antibody based on MorphoSys’s technology with US FDA Approval.

The compound

Tremfya™ (guselkumab)– An investigational antibody targeting IL-23

Tremfya™ (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).

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.

The Interview

Dr. Simon Moroney

Chief Executive Officer

Dr. Markus Enzelberger

Interim Chief Scientific Officer

Tremfya™ (guselkumab) has been approved in the US by the FDA July 13 – as the first drug from MorphoSys’s antibody technology platform. What does that mean to you and MorphoSys?
Simon Moroney:
This is fantastic news for all of our stakeholders – for patients, our partners and shareholders, for our employees. We’re very happy that this therapy will now be made available to patients living with moderate to severe plaque psoriasis. This is also a landmark in the history of MorphoSys. It is the best possible validation for our antibody technology. It is also an inflection point on our way to becoming a commercial, product-based biopharmaceutical company And last but not least, this is extremely rewarding for the entire MorphoSys team who worked on this project.

Speaking of the MorphoSys team working on guselkumab – do you remember how the project started?
Markus Enzelberger:
I remember that very well because I was privileged to be a member of the core team that worked on discovering guselkumab back then. In 2000, we started working with Centocor. In 2003, we started the actual work on the IL-23 target for Centocor in the MorphoSys labs. We had to do a lot of basic research at the beginning – for example in validating the target, setting up assays for IL-23 and so on. With a lot of hard work, we discovered and optimized the antibody and delivered it to Centocor in 2005. Centocor, which had been acquired by Johnson & Johnson and became later part of J&J’s pharma franchise under the name Janssen, took the antibody through preclinical and clinical development and registration, and will now bring it on the market.

In October 2016, Janssen announced positive phase 3 data with guselkumab in psoriasis. What did Janssen report?
Markus Enzelberger:
Janssen reported results from its phase 3 clinical VOYAGE-1 trial in more than 800 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. As reported by Janssen the study met both the primary endpoints and all major secondary endpoints. In November 2016, Janssen announced that they had submitted regulatory filings for guselkumab to the FDA and the EMA. In March 2017, Janssen reported positive data from two other clinical phase 3 trials with guselkumab in plaque psoriasis.

How does MorphoSys benefit from the granted approval? What is the estimated sales potential for guselkumab in this indication?
Simon Moroney:
We are entitled to an undisclosed milestone payment for the approval and royalties on Janssen’s net sales of guselkumab.

What is the estimated sales potential for guselkumab in this indication?
Simon Moroney:
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 US$ 7.4 billion in 2014 to nearly US$ 12 billion in 2024. On average the analysts covering MorphoSys estimate a blockbuster potential, meaning peak sales potential of over US$ 1 billion.

Is plaque psoriasis the only indication for guselkumab?
Markus Enzelberger:
There is potential in other indications as well. In May 2017 Janssen announced that it will start phase 3 trials in two other indications, namely psoriatic arthritis and Crohn’s disease. We are delighted with Janssen's plans for expanding the range of indications of guselkumab.

Is guselkumab the only potential drug in the MorphoSys pipeline?
Simon Moroney:
Not at all, we see great potential in our pipeline. The most advanced candidates include anetumab ravtansine, being developed by Bayer in a pivotal phase 2 trial in pleural mesothelioma; gantenerumab, being developed by Roche and scheduled to enter two new phase 3 trials in Alzheimer’s disease later in 2017; and, of course, our proprietary blood cancer candidate MOR208 which has started phase 3 development in mid-2017 in DLBCL.

Besides the guselkumab success, how and where do you see MorphoSys positioned on its corporate development path?
Simon Moroney:
Right now we’re at a very exciting stage of our corporate development. Over the past few years MorphoSys successfully transitioned from being a leading provider of antibody technology to a discovery and development company with a promising clinical portfolio. Now we are advancing towards the next stage, namely becoming a commercial, product-based biopharmaceutical company. The increasing visibility on the potential of our partnered discovery pipeline as a growing revenue source, upcoming inflection points for our lead proprietary oncology programs entering decisive stages of clinical development, plus the financial strength to invest at the level required to maximize returns, mean that we are well positioned to build substantial value for all our stakeholders, including partners, investors and patients.

 

Tremfya™ is a trademark of Janssen Biotech, Inc.