Innovating Medical Biotechnology
PROBIOMED, a first-rate Mexican company with a global reach, is one of Mexico’s key biotechnology players.
The Latin American Pharmaceutical Industry Federation (FIFARMA) has estimated that by 2012, biotechnological drug products will account for 12% of global prescription drug sales. In Mexico, PROBIOMED leads the way in the manufacture of this kind of product.
With over 40 years in the market, PROBIOMED started out by manufacturing active ingredients for drug products, originally known as pharmacons and now called active pharmaceutical ingredients. The company now focuses on research and development of biotechnological and generic products.
PROBIOMED’s history is closely tied to medical innovations that have been fostered in Mexico. Since the company began its operations in the mid-1970s in Tenancingo, in Estado de México, “we have manufactured all kinds of active ingredients and drug products. We produced the whole range of sulfa drugs when they were still used and which were subsequently replaced by improved antibacterials. In Mexico we were pioneers in chorionic gonadotropin, heparin, chloramphenicols –a synthetic antibiotic drug once used to treat typhoid–, dipirones, vitamin B12, iodine and its derivatives," says Jaime Uribe, CEO of PROBIOMED.
In 1986 the company started producing drug products and by the 1990s it was manufacturing generic oral, injectable and cephalosporin products. PROBIOMED flourished in the 1970s with the support of various government programs for integration, decentralization and exports, as part of a scheme for companies that complied with certain quality standards. When the country opened up to trade in the mid-1980s, many Mexican pharmaceutical companies went under. “Of the 130 pharmachemical companies, only 10 survived. The ones who remained were those that complied with all the quality programs and requirements. We withstood the test of trade liberalization and we proved that we were internationally competitive," explains Uribe.
At that time, innovation was key to staying competitive and so, at the end of the 1980s, PROBIOMED entered the bio-tech market with the aim of manufacturing proteins that were identical to those produced by the human body but using recombinant DNA technology that freed the company from its dependence on the supply of raw materials. “There are no quantity limits for producing recombinant proteins such as heparin or interferon,” Uribe explains.
Also, biotechnological products carry no risk of viral contamination. “It was a safer manufacturing process to create a product that was identical to that produced by the human body,” he continues.
“Our objective is to save lives and improve the quality of life for people, in a way that is more accessible to society, the government and institutions,” says the CEO of PROBIOMED. And this objective has been met. For example, with the launch of its signature BIOYETIN – rHu-erythropoietin– product in 2000, that increases the production of red blood cells and is mainly used by sufferers of chronic renal insufficiency, it increased competition in the market, playing a major part in driving down prices of these drug products.
Its first biotechnology product, launched in 2007, faced a number of challenges from both within the industry and from government authorities. “No-one could believe that this technology could come from Mexico. People thought it could only be done in Europe or the US," says Uribe.
Ever since, PROBIOMED has set about proving that to be untrue. The company continues its steady growth and is currently producing nine recombinant proteins from gene to biomedication. It is currently in a strategic alliance with the Center for Disease Control (CDC), based in Atlanta in the US, to develop vaccines for Hepatitis C and E, for which no such vaccinations yet exist. It has also entered into agreements with various Mexican institutions such as the National Council on Science and Technology (Conacyt), the National Autonomous University of Mexico (UNAM) and the National Polytechnic Institute’s Center of Research and Advanced Studies (CINVESTAV), as well as with research centers in Europe and Israel.
PROBIOMED currently meets 80% of global demand for the Hepatitis B vaccine – produced 100% in Mexico– and is preparing to launch a totally new product, developed by UNAM scientists and technicians. They chose the company for its production given that it had the infrastructure to handle all the research and development stages: a basic research department, a research and development center exclusively focused on recombinant proteins, a technological development center for drug products which uses chemical synthesis to create an active ingredient, the pharmaceutical development to produce the drug product and achieve its bioequivalence and make interchangeable generic products and preclinical and clinical research centers. “I can’t go into any more details, other than saying that we have already carried out all phase 1 tests and we are currently on phase 2," says Uribe.
Despite strong competition from countries such as China and India, PROBIOMED now has a firm international footing. It sells its products and active ingredients in 12 countries: Guatemala, El Salvador, Honduras, Panama, the Dominican Republic, Peru, Bolivia, Paraguay, Uruguay, Thailand, Pakistan and Ukraine. It is currently at the development stage for registrations in nine other countries: Costa Rica, Ecuador, Colombia, Venezuela, Brazil, Syria, Libya, Russia and Uzbekistan.
PROBIOMED generates over 1,000 direct jobs and provides continuous training and incentives to its researchers. In 2008 it sold around 58 million usd and the company estimates sales of over 60 million usd in 2009 in three different areas: institutional –public health institutions–, the private sector through its distributors and the export market.
“In 2000, government departments were our main client. We felt this was an excessive risk. So we embarked on a change strategy, in order to balance out our sales three ways, 33% for each market segment. In the future we expect our strongest segment to be the export market," says Uribe.