In April 2014, the biotechnology company Oryzon Genomics announced a historic agreement with the pharmaceutical company Roche to license a family of patents on various inhibitors of Lysine Specific Demethylase-1 (LSD1; KDM1A), an epigenetic modulator that regulates gene expression. The two companies entered into a collaboration of research and development of new drugs in the therapeutic areas of oncology and haematology.
The partnership between Oryzon Genomics and Roche marked a turning point in the history of biotechnology in Spain. The sector, which has developed dramatically over the last decade, has withstood the ravages of economic crisis and the decline in public investment in R&D&i. Could the history and future of agent ORY-1001, currently in phase I/IIa clinical trials in acute myeloid leukaemia, reflect the evolution of Spanish biotechnology?
According to data submitted annually by the Spanish Bioindustry Association (ASEBIO), the success of Carlos Buesa's company is synonymous with the expansion of the biotechnology sector itself. In the presentation of the ASEBIO Index in 2000, only a year after the Spanish biotechnology platform was founded, the sector showed positive growth trends (1.03). This index, which shrank in 2001 and advanced modestly 2002 and 2003, reflected the initial hurdles faced by an industry for which accessing external funding and internationalising its operations was no mean feat.
The growth in export and access to venture capital (with initiatives such as the public-private fund Neotec funded by the CDTI [Spanish Centre for the Development of Industrial Technology]) marked a new trend which was reflected in the 2005 ASEBIO Report, 25 years after the birth of Spanish biotechnology. The first projects in the sector were launched in the 1980s, and led to the development of the Biotechnology Mobilisation Programme and the arrival of various multinational pharmaceutical companies in Spain. A quarter of a century later, several biotech companies (particularly in Catalonia, the Community of Madrid, the Basque Country and Andalusia) are continuing the trend initiated on a political level during the first years of Spanish democracy. But what factors had been key in ensuring a positive ASEBIO Index in 2005?
Figure 1. Historical evolution of the ASEBIO Index, which began to give positive results from 2005 with the growth of the sector, improved access to funding and internationalisation. Source: 2005 ASEBIO Report.
ASEBIO concluded that some of the parameters which facilitated this change were related to the entry of international companies, the level of training, access to sources of funding, the demand for products and services and cooperation with universities and technological centres. Cristina Garmendia, who was president of the Association at the time and who would go on to become the Spanish Minister of Science and Innovation, drew attention to the importance of “aligning scientific, technological, business and political expectations” in order for humankind to benefit from the advances in R&D&i.
José María Fernández-Sousa, in an interview which appeared in the 2006 ASEBIO Report, said “it was difficult to be successful doing the same thing as everyone else”. The investigator and subsequent founder of PharmaMar (Zeltia Group) is also a historical figure in the sector, since his vision enabled the firm commitment to marine biotechnology which would culminate in the development and marketing of the drug Yondelis. Backing biotechnology helps us to improve and progress as a society, given its countless applications in areas such as health, agriculture, livestock, food and the environment.
During the 2006-2010 period, the high hopes for the sector were shown to be justified, particularly in Catalonia and the Community of Madrid, which were the regions with the largest private domestic investment in biotechnology R&D. The growth of the sector, also reflected in the surge in biotech companies (305) and users of the industry (942) in 2008, was maintained, so that in 2010 the macroeconomic impact of biotechnology climbed to 1.2% of national GDP.
These positive figures were also observed in Catalonia, a region which over the previous two decades had made a serious and continuous commitment to R&D&i. It was revealed in the first Biocat Report, submitted by the Catalan biotechnology association in 2009, that the scientific production of Catalonia already accounted for 2.5% of European production and 0.87% of worldwide production. The conclusions of this report were clear: the biotechnology sector had grown by more than 30% over the previous decade.
Figure 2. Evolution of R&D&i investment in Catalonia in millions of euros. Source: 2009 Biocat Report.
Far from stagnating, biotechnology in Spain and in Catalonia in particular was producing an ever-greater impact. Subsequent analyses by ASEBIO and Biocat showed strong progress in the sector, which had grown in terms of employment, turnover, the number of patents and R&D investment. From the 1.2% of GDP which it made up in 2010, the sector has gone on to constitute more than 9% of Spanish Gross Domestic Product, according to the 2014 ASEBIO Report.
Figure 3. Evolution of turnover in millions of euros and the weight of biotechnology in Spanish GDP. Source: 2014 ASEBIO Report.
The document does not disregard the negative impact of the crisis on the sector. The biotechnology industry has seen a cutback in R&D investment and in the number of jobs; statistics which contrast with the growth in turnover and number of patents. On the one hand, the sector currently employs 172,939 people in Spain, 14% less than last year. On the other hand, the biotech industry turnover was 95,152 million euros, 20% more than the last cycle, according to ASEBIO. In the presentation of the report, Carmen Vela, Spanish Secretary of State for Research, Development and Innovation, explained that “the results are for the year 2013, a particularly difficult year for science”. Among the conclusions presented, the association again requested an increase in R&D investment, on both a public and private level, since biotechnology had been able to resist the worst effects of the crisis and has continued to give positive results.
As was the case a decade ago, Catalonia is still at the head of Spanish biotechnology. According to the results of the ASEBIO Report, almost 15% of the companies in the sector were concentrated in Catalonia, putting it ahead of the Community of Madrid and the Basque Country, which had around 12%. Oryzon Genomics was founded in a region that has made a clear and dedicated commitment to research into human health. The latest available Biocat Report, published in 2014, emphasised that diseases of the central nervous system (27%), cancer (22%), and cardiovascular diseases (19%) were at the centre of the biotech and pharmaceutical companies’ R&D. As a whole, Catalan biotechnology accounted for 5.8% of GDP in the region, generating a turnover of more than 5,000 million euros. The figures presented show that the historical agreement made by Oryzon Genomics was not an unprecedented move, but rather the result of years of work, effort and growth in a sector with a promising future.