PHARMACEUTICAL INDUSTRY: National company stands out in the research scenario

By Célia Piovan

The clinical research in Brazil has grown and still has room to expand.

The activities taken by pharmaceutical industries located in Brazil in relation to the ones in developed countries have been seriously impacted by technological innovations and by public policies concerning industrial development strategies. For the Minister of Health, José Gomes Temporão, Brazil is known as an emerging country concerning pharmacy, opinion shared by the Research, Development and Innovation Director at Cristália Produtos Químicos Farmacêuticos, Roberto Debom, who highlights the advancement in the company within this area.

Top Team: What is the focus of the research and what area does it seek?
Roberto Debom: Research, Development and Innovation at Cristália (RD&I) are at the core of the knowledge-based society model in developed countries concerning pharmaceutical industry. Despite standing out in the anesthesia and analgesia, Cristália has around 350 products and different presentations which are produced and traded in the Brazilian market besides over 30 countries. Soon, therapeutic classes highlighted by Cristália RD&I cannot be limited by its portfolio, gathering from anesthesia to analgesia, as well as antivirus, anti-inflammatory, anticoagulants, anti-asthma, cardiology and metabolism products, besides biopharma products (hormones, antibodies, etc) and new active principles (pharmochemestry). The biggest example of diversification is the recently launched Lodenafil Carbonate, Helleva®, which acts in a diverse segment, that is, against erectile dysfunction. Such product was internally developed at Cristália, from its active principle to its final product, the first 100% synthetic national product.

TT: How far have you advanced?
RD: A new range of products has been developed, from generics to similars (around thirty products just in Brazil), most considered innovative, patented in the US and Europe. However, the biggest advancement is to be constantly upgrading human and business skills for the development of products, what has been recognized by by several institutions and by the prizes received by the company in the technological and organizational innovation segment in Brazil, like FINEP Award (Cristália was considered, in 2007, the major Brazilian innovative country). It makes us believe that we will be not only the first company to entirely implement the first synthetic medicine totally new to the world, but also that we will keep launching and standing out in the products pioneer market, gradually increasing our innovative portfolio.

TT: How much do you intend to grow?
RD: We intend to be a national reference concerning technological innovation in the pharmaceutical sector and become increasingly independent from the international market in order to manufacture finished pharmaceutical products and expand the possibility of practicing more reasonable prices within the national market and promote the access to such treatments.

TT: What has been done so far?
RD: The new ones include HELLEVA, NOVABUPI, KETAMIN S+, SEVOCRIS, ALIMAX and FENTANEST. The new ones in Brazil exclusively by Cristália are Aramin, Brevibloc, Clonidin, Codein, Difenidrin, Dimorf, Dormire, Droperdal, Endofix, Fenilefrin, Flufenan, Flufenan Depot, Frutovitam, Mytadon, Narcan, Neocaína 0,5%Isobárica, Nepresol, Nilperidol, Nubain, Revia, Tanohalo, Tridil, Xylestesin 2% gel and Xylestesin 5%. The antivirus products developed include Efavirenz (Evir), Ritonavir (Ritovir), Saquinavir (Svir), Stavudina (Svudin), Lamivudina (Lami), Zidovudina, Tenofovir and Lopinavir. The technological portfolio developed by the company through those patents has already reached twenty in INPI and over sixty in other territories (around 20 PTCs), approaching central countries like the USA, Japan and European countires, besides emerging countries like China, Korea and India. We export our products to over thirty countries and we have over 95% of the Brazilian hospitals as our customers.

TT: Due to high cost to carry out the research, does Cristália afford all the investment or do you have any partners? Which ones?
RD: Yes, there are state partners. The main ones are FINEP and BNDES, whereas the first one stands out in the technological segment, BNDES focuses on fabric infrastructure. We can also mention FAPESP and CNPq, who support our projects, directly or not, through our technological partners, such as the unversity or research centers.

TT: How do you see research in Brazil?
RD: I see that the Brazilian research has been growing. The amount of Brazilian Masters and Doctors has grown, what mirrors the ratio belonging to Brazil within the world research, with still good quality. We have published journals and our surveys have been recognized worldwide, like the case of Xilela fastidiosa genome sequencing, as we were the first country in the southern hemisphere to complety unveal the genetic code of phytopatogen due to its complex research, supported mainly by FAPESP, which is the main financial source to research in Brazil. I may assume that Brazilian Science is respected all over the world and our researchers are required in all research centers, not only due to their qualified work but also for optimizing solution of problems, which are generated by diverse conditions they have to work in Brazilian universities, obtaining good results, though.

TT: Can you mention other Brazilian strengths ?
RD: Another differentiation of our researchers is the wide view in relation to Science. Science, which has become increasingly more complex, making them go into specializations and work within just one segment. However, in Brazil, the way of teaching and the entering exams, despite having well known problems, provide a general view, regardless the segment chosen, enabling our professionals to have wider knowledge (though not so deep), generating a unique profile that draws the interest within national and international fields. Such uniqueness of the Brazilian researcher is especially important for the technological innovation segment, where both knowledge, flexibility, open mind and capacity of improvising are similarly important to reach their targets. We are still concerned about the fact that such human resource has not moved from the university to the companies, and around 90% of our doctors are in public institutions and research centers. Therefore, applied research from private laboratories identify such assimetry of placing professionals able to carry out high quality level of research, as it deeply affects our production able to impact our market.

TT: Speaking about skills and professionals, what kind of personnel do you count on ?
RD: Cristália has stood out in the national productive sector, where we own a hundred and six contributors working with Research, Development and Innovation (RD&I), counting on a group of twenty-one doctors, eight masters and twenty-five specialists. We try to reach excellence in applied research, acquiring highly qualified professionals majored in our universities and research centers.