The commercial corporation of advanced therapies, an opportunity to leverage Spanish development and production capabilities in a global and highly competitive market

On Tuesday, March 12th, the Ministry of Science, Innovation, and Universities announced the approval by the Council of Ministers of Spain's first commercial corporation for advanced therapies. An initiative described as "pioneering" by the Minister of Science, Innovation, and Universities, Diana Morant, who highlighted that it "will be dedicated to the research, development, and commercialization of drugs in new advanced therapies in our country."

Advanced therapies represent a new generation of innovative medications based on genes (gene therapy), cells (cell therapy), or tissues (tissue therapy). They have great therapeutic potential as they allow the treatment of degenerative and genetic diseases, including some types of cancer, that cannot be treated using other approaches, making them a cornerstone of cutting-edge healthcare systems.

This initiative is part of the Strategic Project for Recovery and Economic Transformation (PERTE) for Advanced Healthcare with funds from the Recovery, Transformation, and Resilience Plan, and is expected to mobilize an initial public-private investment of over 74 million euros.

With the creation of this commercial society, it is expected to "bring two advanced therapies to authorization and commercialization in 2027 manufactured in Spain," in addition to "making the most of public investment, ensuring access to high-value-added medications, and contributing to the sustainability of the National Health System (SNS)."

How will the commercial firm for advanced therapies operate?

According to the information collected in the explanatory memorandum of the aforementioned PERTE, this action aims to facilitate the availability of advanced therapy medications and other emerging medications under conditions of access that promote the sustainability of the SNS (National Health System). Additionally, it is seen as an opportunity to incorporate innovation into the value chains of Spanish companies. This entity should have the capacity to diversify by betting on several advanced therapy medications and is dimensioned with the goal of being able to bring these therapies to authorization and commercialization.

The commercial society will have a 51% stake from private partners, Insud Pharma and Rovi, and a 49% public investment from the Ministry of Science, Innovation, and Universities through Innvierte. Additionally, it will involve the participation of the Carlos III Health Institute (ISCIII), which will participate in the scientific-technical decision-making bodies.

The private partners have been selected through the call for expressions of interest launched by CDTI last year. Among the requirements established for applicants is the demonstration of their industrial capacity by having the necessary infrastructure for research, development, production, and commercialization of products in the pharmaceutical-health sector, as well as experience in obtaining regulatory approvals for manufacturing and commercialization of medications in Spain and the European Union.

"This is a magnificent opportunity to leverage the existing productive capacities in the country and accelerate the transfer to the market of products and services in the early stages of development in the field of advanced therapies. These capacities are described in the Map that the Advanced Therapies Group of AseBio elaborated in 2023," declares Gurutz Linazasoro, coordinator of the Advanced Therapies Working Group of AseBio, and CEO of VIVEbiotech.
Snapshot of Advanced Therapies in Spain

Spain stands out as one of the leading countries in advanced therapies, both in terms of scientific expertise and the number of clinical trials, with the highest activity in clinical trials across all types of advanced therapies, totaling over a hundred per year, as outlined in the aforementioned "Map of capacities of advanced therapies in the biotechnological industry" in Spain.

The document reveals that the Spanish biotech industry is present throughout the value chain of advanced therapy development and manufacturing. The map identifies 47 entities working in the field of advanced therapies, with 85% involved in cell therapy, 60% in gene therapy, and 49% in tissue therapy.

An important aspect to highlight about the snapshot of advanced therapies in our country is that over 30 biotechnology companies have the capabilities for complete development, from the initial R&D phases to manufacturing, transfer, and distribution.

In this regard, 10 biotechnology companies have industrial production plants in all three types of therapies distributed throughout the national territory. By autonomous communities, the País Vasco occupies the first position (housing six of these 10 companies), followed by the Comunidad de Madrid (two companies), and Navarra and Andalucía (one company each).

The sector has R&D capabilities ranging from target discovery, cell cultures, cell design and manufacturing of scaffolds or matrices, processing and formulation, to vector development such as lentivirus and retrovirus.

It is also important to highlight the sector's capabilities in process development, including the development of conservation or analytical methods, manufacturing and characterization of cell banks, and process development, optimization, and scaling. It also has capabilities in manufacturing, such as GMP cell production, cellular therapy production, development of productive technologies, and equipment and processes for quality control and necessary certifications.

Additionally, the sector has capabilities in key services such as storage and distribution, engineering services, and specialized consultancy.

In summary, the map highlights the great potential of our country with a significant number of companies dedicated to advanced therapies that are developing disruptive innovations to address global challenges. Thus, they face a great need for innovation so that their solutions can benefit the largest number of people and remain competitive in the global market.

An early, intense, and loyal public-private collaboration is fundamental, especially considering that many of the biotechnology companies working in the field of advanced therapies are startups that have emerged from academia. This is why Spain needs to implement instruments and incentives to boost advanced therapies, allowing these companies to grow and consolidate.

"For these reasons, we offer our experience in the sector to the new entity, an experience that has positioned some of our companies in prominent positions in a highly competitive global market," concludes Linazasoro