More than a century has passed since the Nobel Prize in Medicine was awarded for dermatology. Niels Ryber Finsen received the accolade for his pioneering ultraviolet light therapy in 1903 and experts in the field believe it is time the spotlight was once again turned on the condition and the promise of major therapeutic breakthroughs.
Scientists are enjoying success in dismantling dermatology’s Enigma code and, although total decryption is some way off, drug development is surging.
“We are in an era of great change and treatment advances,” says Gitte Aabo, CEO and President of Leo Pharma. “It’s about time the Nobel Prize was awarded in dermatology again and the technological advances we will see in the next decade just might make that happen.”
Her hope and confidence stem from Leo’s 2016 balance sheet success and its activity across collaboration, acquisition and R&D.
Spirits are high at the Danish company – a family foundation with a heritage in dermatology – with its committed strategy to 2025 and Ms Aabo’s Lifetime Achievement Award for prioritising patient care and exemplifying industry values at the recent eyeforpharma conference and awards.
Innovation investment
Leo has the big beasts of psoriasis and atopic dermatitis firmly in its sights and is forging ahead on the quest to tackle unmet needs in dermatology. Its landmark partnership with AstraZeneca and the launch of Kyntheum, the fully-human monoclonal antibody targeting psoriasis, and the phase III hope of tralokinumab for atopic dermatitis are part of an approach that combines traditional pathways and new technology-infused routes.
Leo has invested heavily in its Innovation Lab, which was launched with €60m funding in 2015, and is partnering with start-ups to create a dynamic dermatology network. Fresh focus is being applied to areas such as stress, diet and relationships as well as patient support systems as it bids to find novel ways to manage and defeat debilitating skin conditions.
It has also pledged to build new facilities in translational medicine in rare skin diseases and has 25 potential biomarkers under the microscope.
The weaponry is impressive but the task is daunting, as Ms Aabo outlines: “Precision medicine is developing in cancer but we are still scratching the surface in dermatology. Psoriasis and dermatitis may seem the same in everybody but maybe the picture is more like it is in cancer where you have subsets. Advancing biologics and adding biomarkers for precision medicine is one of the steps we are going to see in the coming years.
“There is a big future in front of us because the majority of atopic dermatitis patients are still treated with steroids, which were invented in the 1950s, so there is a strong need for innovation in this market.
“There are huge unmet needs and the predictions are that the dermatology market will grow significantly over the coming years. It makes it very attractive not only for Leo but for big pharma companies such as Novartis and Celgene that are very active in this area.
“We have been in this field for more than 50 years and really stand out because of our deep understanding of dermatology; what’s going on with the skin, what it’s like living with the disease and the whole ecosystem around the patient. We believe that is our competitive edge.”
The Global Disease Burden Study of 2010 put skin conditions as the fourth leading cause of non-fatal disease burden behind low back pain, major depressive disorder and iron-deficiency anaemia.
Research from the Association of the British Pharmaceutical Industry (ABPI), published in March, revealed that 13.2 million people in England visited their GP with skin conditions in 2016, eating up three million hours of NHS time and £723 million of its budget. The ABPI’s Dermatology Initiative wants treatment of the condition to become ‘an exemplar for integration, self-care and harnessing technology and innovation’.
Bridging the gap
Leo is tracking increases in atopic dermatitis across Europe while psoriasis levels show no signs of reduction.
“We also know that, in many markets, there are long waiting times to see a dermatologist so they will go to see a doctor to get diagnosis but it is really difficult for the doctor and, on average, they only get it right in 45% of cases. This means more than 55% of patients do not get the right diagnosis and therefore might not get the right treatment,” adds Ms Aabo. “But there is a lot of potential in using Artificial Intelligence and imaging through technology to improve diagnosis rates to 90% and above. For instance, we now have the technology to allow the doctor to take a picture of the patch of skin with a mobile phone to aid the diagnosis from a library of information.
“These type of tools also motivate patients to stay on treatment which is a big challenge in psoriasis because it is a long-term disease with no cure that requires daily treatment. If you don’t see progress, it is not very motivating. But we are using imaging technology to build the experience for patients while also creating a tool that can show patients the results they can get by staying on the treatment for its full course. We believe that this imaging tech will bring huge advances in treatment and the motivation to continue that treatment.”
The Leo surge will include gene therapy and the flexibility to push its R&D investment up to 25% of sales as it chases the ambitious strategy through to 2025.
“We will be very active in building partnerships and licensing agreements. It is our strong belief that our expertise is in the skin and understanding it, but there may be other companies further advanced in gene technology so our ability to bridge that gap is going to lead to new and better treatments on the market,” says Ms Aabo.
“We have the privilege of being owned by the Leo Foundation and we have a cash pool in the company but it puts a big requirement on us to run the business efficiently. Where our ownership really benefits us is that we are able to invest for the long run and to invest significantly in R&D. It’s our expectation that up to 75% of our future pipeline will be based on partnership or acquisitions and that will require money.”
Ms Aabo, who joined Leo as a financial assistant 26 years ago, is determined that skin disease is a headline topic over the next decade, and she adds: “Often the social impact is not recognised and it can be seen as a minor cosmetic issue but there is a huge psychosocial impact as well as the physical effects.”
Better treatment for patients
Leo commissioned The Happiness Research Institute to drill down into the corrosive damage caused by psoriasis, gathering the experiences of 121,000 patients around the world. It made for sobering reading but it also generated a wealth of data to inform and drive Leo’s work across traditional drug development, technology-based solutions and understanding key psychological drivers.
The report, published in 2017, revealed that 33% of psoriasis patients were lonely and isolated by the condition while 48% believed that physicians do not understand the impact the condition has on mental health and well-being. The ABPI’s dermatology report recorded that 85% of patients with skin conditions highlighted that the psychosocial aspects of the condition were a significant part of their illness.
“But there is a lot of activity and the progress is hugely exciting. We have multiple approaches such as combining biologics where we may be able to address the inflamation and itch while finding ways to attack more mechanisms at the same time,” says Ms Aabo.
“By running an efficient business, we can increase our R&D investments to bring the potential of better treatments to patients.
“It is an amazing time for dermatology.”