A small company with a huge potential. That’s how the 30-year old pharmacist Fábio Cícero de Sá Galetti defines Farmacore Pesquisa & Desenvolvimento em Biotecnologia (Farmacore Research & Development in Biotechnology), the company of Ribeirão Preto, in the State of São Paulo, he and business administrator Helena Faccioli Lopes created in 2005. The young businessman’s statement is not just wishful thinking. With the aid of the Innovation in Small Businesses Program (Programa Inovação Tecnológica em Pequenas Empresas, PIPE), the program of the State of São Paulo Research Foundation (Fundação de Amparo à Pesquisa do Estado de São Paulo, Fapesp) that gives support to innovating companies, Farmacore discovered a substance that might revolutionize the treatment of tuberculosis: composite 227 (composto 227, in Portuguese), which has showed high therapeutic potential in tests with mice. Although its commercialization depends on tests carried out with humans – which may take years to happen –, Galetti says he’s hopeful. “It’s an efficient drug, easily synthesized, very cheap and with low toxicity,” he claims. “So it’s really a potential product.”

If all goes well Farmacore has a large market ahead of it. Recognized as a global emergency by the World Health Organization in 1993, TB still kills a lot of people throughout the world – in Brazil, which ranks between 13th and 15th in the ranking of countries with most incidence of the disease, die of it at least 6,000 people, most of them poor and malnourished individuals – and its treatment is long. According to Galetti, the patient must take for at least six months a cocktail of extremely strong antibiotics that under no circumstances can be interrupted. “One of the drugs currently available was discovered in 1952,” he says. “It's a composite that has been used for half a century to combat the disease. The need to discover new classes of composites that can help in the cure process of the disease is more than urgent.”

Farmacore is already preparing itself to request the patent for the antimicrobial action of composite 227. The request will be deposited together with the University of São Paulo (Universidade de São Paulo, USP), which also took part in the discovery of the substance. “Competition in this sector is very tough,” emphasizes Galetti to justify the need for patenting. “There are several large pharmaceutical laboratories also looking for new molecules for the TB market.”

A company is born

Farmacore was born out of the work of the Instituto do Milênio de Pesquisas em Tuberculose (Millenium Institute for Research on Tuberculosis, IMPT), created by professor Célio Lopes da Silva at USP’s School of Medicine of Ribeirão Preto (Faculdade de Medicina de Ribeirão Preto, FMRP). “Farmacore is the result of the perception of a group of academic researchers that in Brazil R&D&I programs on biotechnology are restricted to universities and research centers – which, due to their very nature, are not used to develop processes in scale or to promote technology transfers,” says Lopes, who is an expert in the area of biotechnology.

“On the other hand, the representatives of the sector in the industrial area, which is expanding, still face a lack of qualified human resources and don’t have a consolidated internal policy of massive investments in R&D&I,” she observes. At Farmacore, however, there’s no lack of qualified people. A total of eight professionals are involved with it: the two owners – with a degree from the Methodist University of Piracicaba (Universidade Metodista de Piracicaba), Galetti is defending his PhD dissertation in biotechnology at USP-Ribeirão Preto in April –, professor Silva, who is a consultant for all the company's projects, one holder of a post-doc, one PhD, two holders of Master’s Degrees and three undergraduate students in the area of pharmacy. The team gets the extra help of researchers of the area of R&D&I of biotechnological products and processes and benefit from partnerships with scientific and technology institutions.

Three headquarters

Farmacore is currently headquartered at the USP-Ribeirão Preto campus and has three spaces to carry out its activities. The oldest is professor Silva’s laboratory, where the first research of composites against TB were conducted. The other two became available in the beginning of 2008: a brand new lab at the FMRP building, available through an agreement with the School, and two adjoined rooms at the Supera business incubator, which Farmacore has been part of for one year. All the spaces are being adapted in order to comply with the General Requisites for Competence of Essay and Calibration Laboratories and Good Laboratory Practices (Requisitos Gerais para Competência de Laboratórios de Ensaio e Calibração e Boas Práticas de Laboratório) of the Brazilian Associationm of Technical Norms (Associação Brasileira de Normas Técnicas, ABNT), as well as to the norms of the National Institute of Metrology, Standardization and Industrial Quality (Instituto Nacional de Metrologia, Normalização e Qualidade Industrial, Inmetro).

The company is already using FMRP’s new laboratory to test composite 227 and other substances in small rodents, which are kept in cages along one of the walls. The two rooms at Supera, with a total of 48 square meters (517 sq. ft) – two times the area the incubator usually offers to its guests –, were reserved for preparing agents, sterilization, staggering and molecular engineering. They have round corners to prevent the accumulation of impurities and have the so-called passe-partout system in all of its micro-rooms – this system prevents the scientists that work there from having direct physical contact with one another, thus reducing the chance of contamination.

PIPE

Farmacore submitted its requests for funding to PIPE in July of 2006. Because Galetti had already detected encouraging results in professor Silva’s laboratory, the project, entitled “Avaliação da Atividade Antimicobacteriana e Segurança Terapêutica do Composto 227” (Evaluation of the Antimicobacterial Activity and Therapeutic Safety of Composite 227), was approved in the same year directly to the program’s Phase II. “We didn’t need to prove the technical viability of our project,” he explains. The company got approximately US$ 170,000 from Fapesp and is using the money to purchase equipment and hire outside services. “The money was important to create the infra-structure minimally required to carry out the research,” points out Lopes.

One of the state-of-the-art equipment purchased with PIPE’s money was the Bioflo 415, an imported large scale fermenter with a 20 liter (5.3 gallons) capacity. “I can say for sure that this is the only one of its kind in South America,” says Galetti proudly, showing the large machine, which is already in operation. The fermenter is important for the company because it’s capable of working with pharmaceutical products in large scale and with precision in the flow of oxygen, in temperature and in the pace of shaking.

Future

In 2007 alone Farmacore tested more than 2,000 composites of Brazil’s biodiversity – fungi, algae, bacteria and plants –, in addition to composites of chemical synthesis, in its quest for new potential anti-TB drugs. It succeeded in extracting 46 composites that combat the TB bacillus, and, among those, discovered two new molecules with better activity against the disease than those of the medicines currently available in the market – and one of them is precisely composite 227.

For the time being the company’s focus will continue to be the development of research such as that. But in the short run its objective is to work performing services in pre-clinical and clinical studies of vaccines and pharmaceutical and biopharmaceutical products. It also plans to develop composites for vaccines from DNA, cell therapy and immunotherapy of illnesses such as cancer, AIDS and TB.

Another of the company’s plans for the future is to consolidate itself in the project of the Ribeirão Preto Technology Park (Parque Tecnológico de Ribeirão Preto, PTRP). The project is an initiative of the Secretary of Development of the State of São Paulo (Secretaria de Desenvolvimento do Estado de São Paulo), the Ministry of Science and Technology (Ministério da Ciência e Tecnologia, MCT), the Ribeirão Preto City Government and USP to turn the city into a large technology center in human, animal and vegetal health, biotechnology, agribusiness, information and communications technology, and in the medical-hospital sector. Ribeirão Preto already ranks fourth in the State in the area of health development and hospital technology.