Lucio Rovati, President,

Rottapharm Biotech

"We are scouting for those opportunities that can have a disruptive effect in the field, and that can make a real difference in people’s lives."

Can you introduce Rottapharm Biotech and walk us through some recent milestones? The roots of the company go back to Rotta Research Laboratorium, founded by my father in 1961. It was originally a small laboratory dedicated to the creation of new medications. Progressively, it became a pharma company with a strong focus on R&D, and eventually, one of the first and largest Italian pharmaceutical multinationals. In 2014, we transferred the company’s commercial operation to Meda, a major Swedish MNC later acquired by Mylan. However, we retained what I call the soul of the company: 5,000 m2 of R&D labs operated by 100 scientists. Rottapharm Biotech originates as an R&D spinoff of Rottapharm Madaus. In the last 12 months, we restructured the R&D business according to three main pillars: The first is concerned with the continuous development of in-house projects. The second is to look for external promising projects and lend support to their development. The last is to collaborate with small biotech companies that already have their own operational capabilities by providing them with our strategic and financial input, for instance by becoming a part of their board. Rottapharm is currently developing a DNA vaccine against Covid-19 with Takis. How is the development progressing? We decided to look at something different and not replicate the RNA or viral vector methods that Big Pharma pursued. We found an excellent opportunity with Takis, a biotech firm with sound expertise in the development of DNA vaccines for cancer, quickly adapting their technology for Covid-19. We helped them find the appropriate manufacturing facilities and set up non-clinical and clinical activities. Because this is the first DNA vaccine to be tested clinically in Europe, the regulatory process has been slow, but we should have the preliminary data by the end of August. Today, we are close to completing Phase 1 Studies. DNA vaccines are relatively underexplored and boast significant advantages. First, DNA information is longer-lasting than RNA genetic information, which means that the possible response from the vaccine could also be more persistent. Also, DNA is a very stable molecule, not requiring a cold chain as opposed to RNA vaccines. However, DNA is also a bulky molecule, which means it does not enter the cell by itself. We use a technique called electroporation through which we administer a small electrical input together with the injection. This opens some pores on the surface of the cell and allows the DNA to enter and to be translated into the actual protein. Therefore, the procedure of administration is slightly more complicated. Rottapharm Biotech is focused on rheumatology and osteoarthritis (OA), in particular. Could you update us on your latest research developments? We have always focused strongly on rheumatology and specifically on OA, one of the most common and most difficult to treat rheumatologic conditions. In fact, we invented the first formulation of glucosamine sulphate, approved in Germany in 1974, and which became one of the most commonly used OA remedies. We understood that there are different forms of osteoarthritis, caused by separate factors like obesity, inflammation, metabolic derangement, etc., and that a single drug cannot be effective for all kinds of patients. Today we are targeting the phenotypes (subsets) of osteoarthritis through monoclonal antibodies and small traditional molecules. We are also in Phase 2 of a clinical trial for a small molecule, an analgesic called CR4056. This is proving to be very effective against the symptoms of this disease. While working in rheumatology, we realized that one of our compounds, which originally seemed like an anti-inflammatory agent, actually had an immunological component. Since rheumatoid arthritis is mainly an auto-immune disorder, we developed a compound for this disease called CR6086. We are now developing this compound also in cancer, combining it with immune checkpoint inhibitors, to which some cancers do not respond. Specifically, we are doing a clinical trial in colorectal cancer, combining our compound with immune checkpoint inhibitors. What are Rottapharm Biotech’s priorities in the medium term? While pharma companies need to be focused on both innovation and commercial activities, we are proud to be completely devoted to the development of new and innovative medications. We are scouting for those opportunities that can have a disruptive effect in the field, and that can make a real difference in people’s lives. Rottapharm positions as a link to pharma companies wherever they may be in the world.

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