Bertil Lindmark, Almirall’s chief scientific officer, discusses the state of R&D in Spain today and outlines the key strategies the company is taking to provide valuable medicines and cutting-edge technologies to patients in Almirall’s R&D core areas of respiratory and dermatology.
How do you perceive the R&D infrastructure of Spain today?
As a company, I am very proud to say that Almirall is the first pharmaceutical and the fourth biggest investor out of all sectors in Spanish R&D. We invested 18 percent of the company´s sales in R&D in 2013. We cover all R&D phases from initial hits to registration of a new drug. However, one would like to think that a country of this size should have more companies spending even more than Almirall has. Spain has the necessary infrastructure to support R&D based business and to make this type of industry promising and profitable. The quality of secondary and tertiary education in Spain is very high, allowing us to obtain truly talented individuals for our organization. Maybe the issue is that Spain is on a curve that lags slightly behind other parts of Europe. Nevertheless, from my vantage, the Spanish government is working hard with the industry to promote R&D based industries, and to enable funding at the national, European, and global levels, and we can feel that support.
What are Spain’s strengths in the pharmaceutical/medical research area?
I am impressed by Spain, and in particular Barcelona, for its level of medical education and profession. The way hospitals are organized and the way people become experts in different therapeutic areas is a strong point for Spain and Spanish medicine, based on the country’s traditions. Barcelona has a respiratory network and looking at pharmacoepidemiology, and preclinical and pharmaceutical R&D, we can easily find expertise throughout the country.
You spent a number of years working at AstraZeneca; what attracted you to this position?
I was actually working in Japan for AstraZeneca, and I saw that Almirall was going through a phase of real positive change. AstraZeneca had opportunities with a number of products accompanied by a strong commitment to R&D. In my position at AstraZeneca I had some degree of influence, but the ability to truly influence the R&D agenda and to broaden my leadership to all parts of pharma R&D in Almirall was the real attraction to move.
What have been some of the most important achievements in terms of R&D since you joined?
We have been able to modify and evolve the R&D area into a more dynamic and agile organization. This required the invigoration and modernization of the management and leadership style in Almirall´s R&D, and allowing a new generation of leaders to progress. Today we run a program called Smart Pharma, which teaches employees how to better understand the business, how to invest, and to lead people, how to accomplish real change and how to develop and use networks for the benefit of the business.
In addition, Almirall has enjoyed successes providing innovative products to patients around the world like Eklira® Genuair®, Constella® and Sativex®. Before I came, the company had been investing in these products which are fantastic but difficult to bring to the market. For Constella, the clinical and regulatory teams in R&D innovatively used only American data to bring Constella to the European market by expressing the results in the format of the European endpoints and thus providing a very good file. Sativex is a cannabinoid-based product, which means we had to work hard to change the narcotics legislation in many countries. As such, the regulatory team here has worked tirelessly to get Sativex to patients. Furthermore, we have developed and industrialized the production of a best-in-market multi-dose dry powder inhaler, named Genuair®, which has been received extremely well by patients in the form of Eklira® Genuair®, a twice daily LAMA (long-acting antimuscarinic), which helps patients with COPD to breathe easier. That drug project started in 1996, and is a unique piece of Almirall history. No one in the company knew how the product would eventually come to fruition; after a number of strategies for creating an inhaled product, the acquisition of Sofotec allowed us to develop and improve an inhaler, and run a clinical trial program with our own compound. It was a long evolution, but now we have Eklira® Genuair® as our number one selling product. Essentially, you need tenacity, a willingness to invest and the determination to see these projects succeed.
Almirall has an interesting model that combines an R&D pipeline with strategic acquisitions. This is a trend globally; how important is the R&D strategy in Almirall compared to big pharma?
64 percent of our products come from our own R&D, which is a high rate in the industry. If you look at where big pharma products really come from, only about 20 percent originate from the company itself. Almirall employs a dual strategy of high market penetration and excellent quality through our R&D products and third party drugs. With our R&D compound aclidinium (Eklira® Genuair®) for COPD we are second LAMA to enter into the market in Europe and the US, which is impressive for this size of a company based in Barcelona. Constella and Sativex are unique first-in-class licensed products, the first one for irritable bowel syndrome with constipation and the second one for spasticity in multiple sclerosis. We do continue to invest in R&D but are constantly on the hunt for meaningful products that can add to our portfolio.
The main therapeutic areas for Almirall include respiratory, dermatology, gastroenterology and pain. What are some of the main pipeline products that you are excited about?
In respiratory we have a combination of aclidinium formoterol for COPD, in the regulatory phase in the US and Europe. In dermatology the most advanced product is a once-daily pill for psoriasis that has a degree of efficacy slightly below the biologicals, bringing major therapeutic benefit, currently finishing Phase III. Furthermore the recent acquisition of Aqua Pharmaceuticals is very exciting for our US activity and the company’s market insight and experience provides new perspectives for our pipeline in terms of which derma products they would like us to bring to the US.
What is the typical strategy for Almirall in terms of how it engages with clinical centers and how you attract patients to participate here and abroad?
Small specialized studies like SAD/MAD and early phase trials in dermatology often go to specialized centers. We recently finished a MABA program, which is another exciting respiratory product. It is a bi-headed molecule that creates two activities in one molecule which makes it possible for a triple combination when you add a steroid. We are one of the few companies in the world that has such a molecule. For larger trials we look for large contract research organizations to help carry out these complex trials.
Almirall has one research center here in Barcelona and two in Germany. What is the strategic importance of each of these centers?
The molecular brewery is here in Barcelona. This center has very good chemists and preclinical pharmacologists, as well as the core of regulatory and global clinical development with biostatisticians and clinical operations. One center in Germany focuses on dermatology through reformulation and topical formulation innovation, repositioning drugs and reformulating known molecules into topical treatments. We currently research a topical combination therapy for psoriasis, in one formulation which brings down the side effects of steroids on the skin and increases their potency. The second German centre, Sofotec, focuses on inhalation technology. There we have engineers focused on the characteristics and patient friendliness of the inhalers, and how they and the drug formulations we use compare to other product.
Would Almirall ever consider expanding those R&D activities to its other two niches?
I think we will build on these centers primarily in respiratory and in derma. Almirall has no centers that focus on gastroenterology per se. In that regard we work with partners and we are recognized for our knowledge in key markets where we are present and the ability to work with KOLs. We also have a very good contact network throughout Japan, US, Europe in our key therapeutic areas.
What do you look for in a partner? What synergies can Almirall offer?
Our inhaler and the series of compounds we have in respiratory provide many opportunities for inhaled therapy. We have one of the best pipelines globally for inhaled bronchodilators. In dermatology we have a series of oral and topical products that have unique niches and features. Furthermore, we have the chemistry that allows us to create compounds that travel to the lung, stay there, and provide efficacy in the lung. We can transfer this knowledge to understand how we can make molecules that penetrate the skin, stay in the skin and do the efficacies locally. Obviously, our capabilities for small molecules and our topical formulation technologies are our key areas of unique expertise.
How do you attract people to work at Almirall, or do you look for people?
It was always a combination. To obtain the best talent requires looking for it across many nationalities. Candidates realize Almirall is a company of good size which enables us to be agile and flexible in order to make fast decisions. You can work for many years in big pharma and still never be able to truly influence or even understand the company. In that sense a company like Almirall is more transparent. All teams, from global marketing to R&D, work very closely with one another, so that when a product becomes industrialized, people understand the product and their role in the process of its creation. Maybe our R&D output in terms of scale is the same of big pharma 50 years ago, but being able to control the central parts of the R&D process is fundamental, and something which we can do with our size.
How do you personally encourage innovation in the company?
An R&D organization by definition is an innovation organization. Having said that, who will innovate and why? You have the entire spectrum from organization to process to product innovation. We are running an organization with good discipline by looking at targets and achieving them. Additionally, last year we started Essentia, an innovation network inside the company where we elicit ideas from all of our staff. Almirall also presents innovation awards, and we have an external innovation network where we work with Spanish and European industry. Innovation in pharma means that you need empathy to understand what is problematic for patients or physicians or the healthcare system in order to innovate something valuable. So, innovation is about brains, empathy and actually daring to say anything, and start with something incomplete, that through the work of many, becomes meaningful.
What do you plan to achieve in R&D in the short-term?
We will continue working in our areas of strength in small molecules but also with other technologies, trying to create really valuable medicines in dermatology and respiratory which address the patients’ unmet needs.
What would you personally like to achieve?
I would like to be able to run an exceptionally effective R&D organization that has accomplished creating real products that make meaningful difference in people’s lives. The ones that we have taken to the market so far are great but I would like to accelerate the way we do innovation and research even more. We have tackled some large scale diseases like COPD and IBS-C, but I would like this organization to increasingly focus on even more difficult diseases to treat and with a clear specialist focus, where the therapy could potentially be transformational.
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