Disclosure: The European Medical Journal has engaged in business transactions with Almirall S.A.
Members of the EMJ team were delighted to meet Mr Rajesh Gupta, the Global Marketing Dermatology Director of Almirall, S.A. (Barcelona, Spain), for an exclusive interview on Tuesday 10th October 2017 to discuss the company’s European launch of Skilarence®, an oral formulation of dimethyl fumarate used for the treatment of psoriasis. We also had the opportunity to speak about other areas in which the company engages in research and development, including rare skin conditions and education programmes.
The inspiration for the development of Skilarence lay in the success that dimethyl fumarate has already had in Germany since 1994, where it is known as Fumaderm®, which is regarded as a safe and effective therapy. Therefore, Almirall utilised the opportunity presented by Fumaderm’s success to develop an upgraded oral version that could be made available across Europe. Following recent approval from the European Commission, this target will be achieved in the near future. “It [Fumaderm] is the number one prescribed systemic drug for psoriasis [in Germany]; it is used by over 70% of dermatologists in Germany,” explained Mr Gupta. “We knew because of the history of that drug, the safety and efficacy, it would be an option that dermatologists around Europe would like to have in their armamentarium for fighting psoriasis, and the only way to do that was to do a new development, a new trial, and then place a regulatory application to the European Medicines Agency (EMA) and get it approved Europe-wide.”
The extensive use of dimethyl fumarate in Germany demonstrates why it is so important that a new formulation is available to other parts of Europe. Many countries, including the UK, have to import the drug from Germany for their patients when appropriate, which is not an ideal scenario due to the economic and logistical burden it represents. Mr Gupta informed us, that in addition to the UK and Germany, he expects that the treatment will be rolled out in other major European markets, such as Italy and Spain, over the next 3–9 months, once local pricing has been authorised.
In the UK, a major success for Almirall has been the recommendation from the National Institute for Health and Care Excellence (NICE) for Skilarence to be used when the disease has not responded to other systemic therapies, and Mr Gupta explained that this process was very straightforward, due to the significant advantages that Skilarence offers in comparison to other treatments, in addition to its already well-known safety and tolerability. Firstly, it may be taken orally rather than requiring an injection, which Mr Gupta commented: “is very attractive for patients and for physicians.” “It’s a drug that can be used straight after, when the topical therapy they might be using for their psoriasis is no longer providing the efficacy the patients need. So, you don’t have to go on to injectable drugs straight away, you can have an in-between solution now, which is an attractive option.”
The importance of having a non-biological treatment option was further outlined by Mr Gupta: “Some people do not like using biologicals because they are injectable; patients sometimes don’t like that. Secondly, they do have their own issues: they can cause side effects, like infections, and they can cause other diseases. So, it’s not for everybody and, of course, they cost a lot of money.”
The relatively low financial cost of the drug in comparison with other treatment options also makes it an excellent proposition for healthcare providers such as the NHS, particularly in the current economic climate. Mr Gupta elucidated: “Of course, the cost is very attractive, because it doesn’t cost as much as biologicals. It doesn’t even cost as much as the old Fumaderm, so we provide it at a very competitive price, which is also, in these days of budgets and the pressure on the governments, passed down to the physicians as an attractive option to use before [patients] go onto a biological drug, which can be four or five-times the price.”
Additionally, Skilarence is particularly useful for tailoring the correct dosage depending on the individual needs of the patient, again making it an attractive option for physicians and patients alike. “They can actually titrate the drug directly according to what is required for the patient,” explained Mr Gupta. “It is a highly tailored therapy, because you can titrate up and down the required dosage. So, the patient only takes in whatever they need and whatever they can actually tolerate in terms of the side effects. You have a nice balance of efficacy and safety and this is something very attractive to the patients.”
The company also received a very good reaction to the drug from physicians at the recent European Association of Dermatology and Venerology (EADV) Congress in Geneva, Switzerland. “The reaction to Skilarence was very positive; a lot of dermatologists were very thankful that Almirall took the opportunity to develop the drug on a European-wide basis,” said Mr Gupta.
We also asked Mr Gupta about the work of Almirall more generally, including the types of areas it is targeting and the company’s ambitions for the future. Mr Gupta emphasised that Almirall is very much focussed on dermatology alone and aims to be one of the leading dermatology pharmaceutical companies around the world. Founded in the 1940s in Barcelona, where it remains based to this day, Almirall’s focus shifted from respiratory health to dermatology in 2014. Explaining this concentration on skin ailments, he stated: “Dermatological diseases are huge population-based diseases, so psoriasis, for example, affects around 2% of the world’s population; 1 in 50 people will have psoriasis around the world. It’s a huge number of people; 125 million or so, which means you are always going to need more therapies, maybe not from just an efficacy point of view but more from a safety and tolerability point of view.”
Mr Gupta added: “More therapies that can provide you long-term clearance, for 5 years or 10 years when you use it, because these diseases are chronic, and once you have it there’s no cure. So, you need more things that can be used long term. Efficacy and safety, combined with tolerability; these are the kind of things that dermatologists are looking for, and as many drugs as possible that can be developed to help them is a positive from my point of view. Companies are still developing biological drugs even though we have 60%, 70%, 80% clearance on the skin. They are still developing more biological drugs because in the future you may only have to take one injection every 12 months rather than one injection every 2 weeks like they have to now. That’s the kind of innovation that people will like to see in drugs.” A particular focus of Almirall’s, as displayed by the development of Skilarence, explained Mr Gupta, is the more mild-to-moderate psoriasis patients; while biologicals are generally very effective for the more severe cases, alternatives including topical and oral therapies are required, with little innovation seen for the non-severe patient cohort.
Aside from psoriasis, which is clearly a big focus for the company, Almirall engages in research and development in many other dermatological conditions. “In the USA for example, we have products for rosacea and acne, which are very highly sought after and well sold. And then we also look at the second and third tier of diseases, like actinic keratosis; it’s a very dangerous disease and a precursor to carcinomas of the skin. So, it’s very important that we continue to work in that area. We have a drug, called Solaraze®, which is the number one drug for actinic keratosis.”
In keeping with the desire to be a leading dermatology company, Mr Gupta stated his wish for Almirall to develop treatments for rare skin conditions as well: “Because we want to be a long-term partner for dermatologists, we don’t want to just focus on the big-disease areas; we want to focus on all dermatological diseases where there are unmet needs. These include some of the rare diseases, where all the patient numbers are very low and the need is very high, because they have nothing else available for treatment. So, we have in our pipeline some work that’s been done in those areas as well.”
Mr Gupta was also happy to discuss ongoing trials of promising new treatments developed by Almirall, which could potentially yield some vital new tools for physicians tackling conditions with high unmet need. “The main one is a drug called tildrakizumab, which is a biological drug currently being studied in ongoing clinical trials for psoriasis. We will be doing some more Phase IV trials for Skilarence and we are doing trials for drugs to treat atopic dermatitis,” he informed us. “We also have trials ongoing now in Europe for a disease called nail psoriasis. It’s very difficult to treat; it’s a disease with a very high unmet need. Also for androgenic alopecia, which is hair loss that is androgenic, and we have trials in a condition called onychomycosis, nail fungus, which is also a very high unmet need disease, mainly because a lot of people are now living longer; diabetes is increasing, cardiovascular disease is increasing, and a wide range of these patient groups, the elderly and the diabetic groups especially, normally get fungal disease of the nails that goes unseen for many years. It’s a chronic disease that has to be treated, otherwise you will get complete dystrophy of your nails. These are the areas where we have the main clinical trials ongoing right now.”
Looking to the future, Mr Gupta explained his belief that treatments based in biomarkers will be the next big focus of drug therapy. “I think it will be drug therapy based on biomarkers and knowing exactly which drug works in which patient and doesn’t cause side effects. So, it will be more biomarker-led therapy, which will be fantastic. You know you can do a simple blood test and know that if this patient is given a specific therapy, it will work, rather than having to try and fail,” he stated. Almirall are looking at these types of trials for future drug development.
Education is another sphere that Almirall actively participates in. There are, of course, the various sessions and symposia that Almirall organises at major dermatological events worldwide to spread awareness of conditions and available treatments; in addition to this is the development of patient-centred education, often in conjunction with other bodies. Listening and responding to the needs of patients in this respect is key, according to Mr Gupta. Primarily, this relates to ensuring the correct usage of drugs, but also in other areas where the knowledge of patients is lacking. “We have a group, called the Patient Advisory Group, where we have invited five of the individual organisations around Europe to send their representatives to come and give us the areas where education is more needed. Based on their comments and input, together with them we then develop the programme so they know that this will be something that patients will want to listen to,” he explained. “Then, in reverse, what they do is take the information back and channel it through their sources, their websites and through their paper programmes, so that they’re going to educate their membership directly. It’s like working in partnership with them.”
It is clear from speaking to Mr Gupta that these are exciting times for Almirall, and the EMJ looks forward to seeing the company continue its far-reaching and important work in the field of dermatology in the future.