Read the Conversation
EF: What are PharmaMar's key priorities, and what can we expect from it in 2024?
LC: 2024 is an exciting year. We expect to receive a lot of data from our ongoing clinical trials. Our number one trial is in small-cell lung cancer. This important trial is focused on first-line maintenance therapy. We expect the top-line results of this trial to be available at the end of this year. If the results of the trial are positive, this will be transformative for patients and the company.
We are also expecting to finish the enrollment of the second clinical trial in small cell cancer in the second-line treatments. We will be pushing our pipeline more aggressively in 2024, particularly for our first-line leiomyosarcoma trial. There have been no new treatments for leiomyosarcoma first-line in more than 40 years. It is nothing new, and there is a huge medical need and a big opportunity for the drug and the patients. The other two products in the pipeline are in phase one. We are expected to finish phase one this year and prepare phase two for 2025.
In 2025, we expect an increased effort in clinical trials and new data generation. In addition, we expect new approvals around the world for our drug, Zepzelca. It is currently approved in 14 countries such as the USA, Australia, Mexico, Canada, etcetera. We expected more countries to approve it, such as China and Argentina. We hope to expand it to big countries and good markets bit by bit around the world, which could be a reference standard in second-line treatment for small cell lung cancer.
EF: In a world of synthetic medicine, gene therapy, and artificial intelligence, why are you so committed to developing products of marine origin?
LC: Developing products of marine origin is the reason why the company was founded in 1986. The original idea was to search the sea for new compounds that could be used in cancer treatment. The majority of products use elements discovered in nature, such as bacteria, trees, and plants, but not from the sea. This is absurd because the sea covers 75 percent of the earth’s surface, and about 80 percent of biodiversity is in the sea.
The probability of having new compounds or molecules in the sea is much higher than on land. We need to consider that life started in the sea. The organisms then moved to the land, and according to evolution, the original invertebrates and bacteria were in the sea. This idea was the basis on which PharmaMar was founded. We continue with this idea because every year, we organize between five and ten expeditions around the world for exploration of the oceans, including the Atlantic, Pacific, South, and North, to seek out new samples. We collect invertebrates and bacteria, but this work is not easy because we need to respect the Nagoya protocol and other rules of biodiversity conservation and sustainability.
Our divers and marine biologists go in deep, between 30 and 100 meters, to collect the samples and organize all the logistics. The samples are delivered to PharmaMar, where we start the discovery process. The discovery process is a screening process. After this process, we use the lab to reproduce what nature has offered us. If we cannot reproduce the compound, we abandon the exercise. We need to be able to reproduce these complex molecules in the lab. This is part of R&D, and PamaMar has a strong interest in R&D. It is in our DNA. If you do not invest in R&D today, it is impossible to cure tomorrow.
The company has three compounds that have already been approved for four indications of cancer. Our continuous success rate is much better than the approaches. Clinical trials are another part of R&D. Until 2007, the company was, for a long time, fully R&D oriented. In 2007, the company achieved historical approval for the first marine-origin anti-cancer drug. That was the first Spanish drug approved by a centralized procedure by EMA. Previously, no Spanish drug had been approved by EMA through a centralized procedure. It was a big success that the president of Spain and the King celebrated with us.
However, in 2007, the company shifted to being more customer-oriented and market-oriented. The company transformed into a fully integrated company. From the sea discovery to the patient. In 2009, there was the second approval for ovarian cancer treatment, Yondelis. Aplidis was approved in Australia in 2018 for the treatment of multiple myeloma. We have come a long way from when the company was founded. Our president is a former biochemistry professor, and he pushed us to where we are today.
EF: Could you elaborate on PharmaMar’s R&D capabilities and the innovation that you do in Spain? Why is Spain a good place to do this?
LC: Firstly, our founder is Spanish and logically decided to invest in Spain, his home country. A better question might be: "Why Madrid?" Because it's so far from the sea. Madrid is a very big hub for universities, with good communications around the world, a big airport, and a good quality of life that attracts and incorporates the best talent from around the world. We work with 18 different nationalities.
Our projects interest many people around the world, and we attract them to South America, Europe, North America, and Asia. This leads to different points of view and different cultures. Our push for innovation is not endogamic. The innovation is based on our drugs and their effectiveness when they arrive at the patients. The innovation in PharmaMar drugs is in the different mechanisms of action.
When we look at the screening process, the mechanism of action is different from what has already been proven to kill the cancer cell in a different manner than the other drugs. This offers more opportunities for the doctors in their fight to treat cancer. This is one of the better approaches to supporting innovation. Personalized medicine may also offer the doctor several different mechanical functions and different drugs to offer the patient. This leads to better results for the patients.
We have 19 partners around the world. All the areas of the company are involved in partnerships. Our R&D works with national R&D centers, universities, and other companies, and we collaborate on the platforms of the European Commission to access financing for our different projects. Since our inception, we have had agreements with our university, Tokyo, Mexico, Australia, and others around the world. Collaboration is so important today because you need it to open the door to other projects.
When I started working here in 1986, the idea of opening up the R&D was almost impossible. You needed a lot of effort. However, with the advancement of communication and the internet, it is now easier to collaborate and be more competitive.
EF: PharmaMar went through a reverse merger in 2015 and a pandemic in 2020. Could you talk to us about managing through these times of transition? How did the company adapt, and what did you learn from these different periods?
LC: These periods were certainly not easy because, traditionally, biotechs do not have a lot of money. Our evolution is in parallel with R&D achievements and successes. An important drug was approved in 2007, a second approval was granted in 2009, and a reverse merger occurred in 2015 because the company was too large.
Through the years, we have developed a clear picture. PharmaMar was a listed company from the very beginning. Zeltia was the headquarters. Being a listed company opened up more opportunities for capital increases and loans that enabled us to maintain the level of investment in R&D.
We have developed a clear picture throughout the years. PharmaMar was a listed company from the very beginning, and Zeltia was the headquarters. Being a listed company opened up more opportunities for capital increases and loans that enabled us to maintain the level of investment in R&D. Small biotech companies in Europe have many obligations and have to create value for investors and shareholders so that they understand the value of the company across the R&D evolution. But this isn't tangible until the drug is approved. Companies that have products have immense value. This is an intangible asset, and it is difficult for the market to understand these types of companies.
The history of Spanish biotech companies is long. Historically, the political situation has not been friendly to R&D. Bureaucracy was another hurdle to R&D. Spain is probably number two in the world for clinical trials. How much time do you need to start a clinical trial? When you complete a trial, the European Commission gives a green flag for the approval of the drug, which is then reimbursed by the authorities. It can take more than two years. The ecosystem is not favorable, but we have learned to maneuver in this arena.
To overcome this hurdle, PharmaMar's strategy is to license partners around the world. We keep Europe, and we have partners to deliver our drugs around the world. For instance, if Yondelis gets compensated in one country but not in another, it might be challenging for a lone biotech to obtain it in that other country. A biotech would not have the capability to launch in Argentina, Australia, or North America, but if you have good partners, you can enter the market through royalties. Milestone agreements are another source to finance R&D activities and be a profitable company. Profit is not common in biotech, but we expect to maintain our profitable status in the future.
EF: How do you bring the team together, and how do you instill a constant culture and motivation to push for innovation?
LC: This is an art. PharmaMar has a good mix of interaction with people. We have a total of 450 employees, with 350 working in one facility. Our door is always open to our people. Our employees can approach management easily and talk freely.
Decision-making is quick and streamlined. We do not need ten or twenty meetings to make decisions. If any employee has any problems, they can come to my office and have it resolved quickly. Our people have the chance to see a drug being born in the lab all the way through the process until it arrives at the authorities for approval. This is not normal for most companies because they are very fragmented. I think this is one of the attractions of the company.
Another factor that attracts talent to us is that we are a multinational that has relations with 19 partners around the world, regulatory authorities, and R&D centers. We attend all the meetings and congresses worldwide. This is easier to do as a company that has a worldwide presence. This is not easy for small, local companies.
Spain is a good and attractive country with a good quality of life, weather, food, and people. Europe is the region with the most expensive expectancy of life. There are higher chances of moving around with a multinational as opposed to a local company. There are possibilities for building relations outside the company. We push people to attend meetings to gain knowledge and experience. Sixty-five percent of our staff is female, and 50 percent of our management is female.
EF: Our project is called Road to Sustainable Healthcare. How can you build a sustainable healthcare ecosystem in Spain?
LC: The Spanish healthcare ecosystem is fragmented across the different regions. It is not one unified market. It is very difficult to maintain it because each region has different capabilities. Not all patients across the country have access to the same level of quality.
Spain needs to create equal access across all the regions. We have elections every four years, and politicians need to assess their priorities to determine whether they think healthcare is more or less important than other areas.
The average age of Spanish people is getting older. Spanish life expectancy will be 1.5 times higher in five to ten years. We need to prepare for that and ensure we have the right people when the time comes. We need doctors and nurses. We need to open our universities and make them more attractive to the younger generation who want to join the Spanish healthcare industry.
We also need an agreement for all the politicians to have 25-year plans that will handle large investments and a consensus on the basics we need to have and then move in the same direction. This type of agreement is what the country needs to be sustainable in the future.
EF: Do you have any final message you want to give to our readers or our colleagues from the industry?
LC: I think Spain is a great country to work in, invest in, and establish a company. We need more small businesses and a clear and stable law that eliminates unnecessary bureaucracy.
