Hellen Berger

The pharmaceutical market in Brazil has been growing steadily and strongly in the past five years. The country is eying production and innovation, relying on the key support of the government. According to industry associations, biopharmaceutical innovation in Brazil will increase in the future as the country starts facing its challenges and participating globally with local and multinational companies.

According to Abifina, Brazil’s Fine Chemicals, Biotechnology, and Specialty Industries Association, Latin American countries are still planting seeds to develop and compete in the global biopharmaceutical market. Brazil, however, plays a key role in the sector with a series of universities and institutes promoting research and development actions, a public health system capable of sustaining part of the local pharmaceutical industry, and a large consumer population at more than 200 million Brazilians.


  “Brazil has definitely been growing steadily over the 10% mark in the past five years and we should continue seeing sales increasing annually by 12-15%,” Nelson Mussolini, executive president of Sindusfarma, told 

Sindusfarma is the São Paulo state pharmaceutical products industry association.

According to Mussolini, citing IMS Health figures for the past five years, Brazil’s growth is considered relevant if compared with data for Europe and the US, whose growth levels were around 1%. Mussolini says that the increase is especially due to the fact that the local job market has heated in the past five years and has been transforming the lower classes into active consumers of goods and services.  The country’s impact, however, within the biological products market is limited to production and sales and does not necessarily include relevant innovations, according to Reinaldo Guimarães, intellectual property director of Abifina.

“Our increase of the biopharmaceuticals market share is mainly a result of public investments for the government’s health system,” Guimarães told 

. The government is acting as a main buyer, currently responsible for as much as 25% to 30%, with an estimated participation reaching as much as 50% in the next few years, according to Guimarães. The government is establishing key partnerships with local and multinational, private, and public companies, and is funding local production capacity expansions for public and private companies. Brazil is also controlling the efficacy and safety of pharmaceutical products through market regulation. 

According to Guimarães, considering government expenditures with health products, biopharmaceuticals correspond to only 5% in terms of units sold and as much as 40% in terms of sales.

“The government is definitely investing on the development of the local biopharmaceutical sector through partnerships and by obtaining technology,” says Mussolini.

According to Sindusfarma’s executive president, however, companies face challenges to become profitable and still lack large production scales. It seems that Brazil-based companies seek to increase production scales and profitability, while government seeks less dependence on imports and a stronger local market, establishing a strong pharmaceutical partnership intended for growth.

With the economy still under control and regulation equivalent to those of developed nations, challenges now lie within high taxes and costs as well as strict price controls, according to Mussolini. Such issues impact profitability and affect future R&D actions as well as most companies’ long-term survival.

“Brazil competes globally in terms of market share …however, to become a global competitor in terms of new products or better products we still have issues to face,” adds the official. In terms of R&D, for example, challenges are attributed to the country’s lack of technological capacity to produce relevant innovation, says Guimarães.  

The Brazilian government through its Health Ministry has the goal of substituting imports for locally produced products by establishing technology transfer deals. Such measures have traditionally been used for vaccines and most recently for synthetic drugs as well as biopharmaceutical products.       


  The global financial crisis, which started in 2008, did not affect Brazil as severely as it affected the US and Europe; therefore, the local pharmaceutical market faced a smaller impact as well. During the past eight years (2003-2011), Brazil went from occupying the tenth position among global pharmaceutical companies to being the sixth largest pharmaceutical market, according to IMS Health. By 2016, a year in which the country will host the Olympic Games, IMS estimates Brazil will occupy the fourth position, with an estimated growth between 1415%, only behind the US, China, and Japan and surpassing the highly established markets of France and Germany. 

“I personally believe those estimates to be very optimistic, however, we are indeed heading in the direction of a 12% growth, which would include Brazil in the fifth position …,” says Mussolini.  

Nonetheless, “I am sure IMS Health knows exactly what they are saying,” adds Mussolini. “I believe there are no reasons for serious concerns,” concludes Guimarães.


Hellen Berger is a business news correspondentbased in São Paulo, Brazil.

Articles

Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator.

Innovation and Market Growth in Brazil

Brazil’s Health Surveillance Agency (Anvisa) published a new regulation, Resolução da Diretoria Colegiada (RDC) 38/2013, on Aug. 14, 2013 that implements patient access to new drugs before they are officially approved and available for purchase. The new regulation offers drug options for patients with rare, severe, or debilitating illnesses for which there are no treatments available or where the existing medication is insufficient. 

  According to Anvisa, the resolution will provide promising access to new drugs without agency registration under a public health program that will be requested by the patient’s doctor. Patients who previously would not have access to treatments before drug registration will now be able to get their medicines through three programs: compassionate use, expanded access, and post-study program.

Medicines access programs
  The compassionate use program will benefit patients with serious or rare diseases. These cases can involve importing new, unregistered drugs if needed. Patients with serious life threatening illnesses may participate through the expanded access program in cases that lack satisfactory treatments, Anvisa told 

. This program will offer new drugs that are not registered with Anvisa, but are undergoing, or have concluded, Phase III clinical trials. The post-study drug-supply program guarantees free drug supply to volunteers who benefited from the drug during clinical trials. 

  According to Anvisa, the authorization approval for the expanded access and compassionate use programs will be evaluated according to the severity of the illness. The current state as well as the absence of satisfactory treatment alternatives available for the patient’s condition in Brazil will also be assessed before issuing an authorization. Anvisa says RDC 38/2013 will benefit patients in Brazil because it guarantees innovative drug supplies to those whose illnesses are chronic or severe according to medical request.

Access to unregistered drugs was already available previously by RDC 26/1999 to patients in Brazil through the expanded access program, Anvisa told Pharmaceutical Technology. The program, however, did not include compassionate use or post-study access and, therefore, had to be updated. 

All three programs were included and are regulated by RDC 38, dated Aug. 12, 2013. “The process for obtaining the drug authorization will not be complex or bureaucratical,” says Anvisa. “The patient’s doctor will need to make a formal request to obtain the drug from the company funding the assistance program and the company will place a request with Anvisa, following RDC 38/2013 ruling.” Anvisa, however, points out that the negative point of the program from the industry’s perspective is the high cost of the assistance program. On a more positive note, data collected through the program may be used by the company as additional information for product registration. 

“It is important to note that the data collected though the expanded access and the compassionate use programs will not substitute clinical trials for drug registration or delay the development of clinical trials for such drugs,” the agency adds. 

Anvisa said the program would not pose any kind of risk or impact to the local pharmaceutical market and that patients will not have access to drugs without medical authorization and request. According to RDC 38/2013, chapter VIII section 18, the company funding the treatment will offer the complete treatment and medication at no cost for the patient under the expanded access, compassionate use, or post-study programs. The company will also be fully responsible for the products used in the program, including adequate stocking and distribution processes, according to the new rules. 

Considerations for patients requesting access to new drugs


  This improved medicines-access initiative has been positively viewed by many industry players and patients; however, patients should bear in mind some key considerations before requesting authorization to access new drugs. First, the efficacy and benefits of these drugs have not been proven considering that they have not been registered with Anvisa. Second, the risks and complete range of side effects of experimental drugs are unknown. Also, while physicians in Brazil tend to be open to patients’ requests, the doctor may not grant access to the new drug if he/she believes that the experimental drug could be dangerous for a specific condition, for example. It is always important to seek advice and ask for a second opinion on specific medical cases, if needed. 

Hellen Berger is a business correspondent based in São Paulo, Brazil.

New regulation offers patients in Brazil greater access to experimental drugs.

Report from Brazil November 2013

In Brazil, there are indications that the pharmaceutical industry has been living relatively comfortably despite global difficulties. Due to improved wages and jobs created over the past few years, thousands of Brazilians who never had access to drugs have been investing in healthcare and purchasing medicines, not only to treat illnesses but also as a means of prevention.

According to the Brazilian Association of National Laboratories Distributors (Abradilan), figures from IMS Health show that sales of pharmaceutical drugs in Brazil are expected to rise 15-20% this year compared to (Brazilian Real) R$49.6 billion (approximately US$21.6 billion) in 2012. The Gross National Product (GNP) for 2013 is expected to be 2.28% higher this year, according to Brazil’s Central Bank.

In 2011, the so-called “C class,” which represents 53% of the 200-million population in Brazil, contributed to 42% of the domestic sales of pharmaceutical drugs in 2011, while the wealthy “A and B classes” were responsible for 48% of total sales, according to IMS Health. Companies operating in Brazil are beginning to understand that it is important to target the middle class as they outnumber the wealthier classes and are willing to pay for all types of goods, including pharmaceuticals. As a result, production of pharmaceutical drugs is on the rise despite the high costs and taxes in Brazil. Investment plans, however, are ongoing with opportunities seen ahead, especially for biological drugs. 

Government plans include local production 


  Biological drugs are cellular- or tissue-based medical products. They include, among others, vaccines, blood components, and living cells used to treat various diseases. The production is mainly though gene-modification processes, rather than synthetic. Producers have reported that biological drugs have greater accuracy to treat illnesses according to the Industry Syndicate of Pharmaceutical Products in the State of São Paulo (Sindusfarma).
  
  In an interview with 

 Nelson Mussolini, executive president for Sindusfarma, said that “there is no doubt that biological drugs have great potential in Brazil. They will add to other drugs offered by the country’s public health system to treat illnesses such as rheumatoid arthritis, asthma, and various types of cancer. This fact can be proven by the actions developed by the Brazilian government to implement local production of biological drugs, through its Health Ministry and the Bank of Economic and Social Development (BNDES).” 

According to Mussolini, Sindusfarma associates correspond to more than 90% of Brazil’s pharmaceutical market share, hosting companies that promote both national and international research as well as commercialize biologics and biosimilar products. “The health ministry would guarantee purchasing these drugs under the public health system and the BNDES would guarantee funding and financing for research and production of biological products,” added Mussolini. 

The topic of biologics production has definitely caught the interest of policy makers, and the pharmaceutical industry sees it as an opportunity given that the government in Brazil is developing the biologics market. The Brazilian government strongly supports research partnerships in this field and is encouraging local production of biological drugs. According to Sindusfarma, the government is willing to pay as much as 25% more for locally produced biological drugs compared to what it pays for imported products. 

Mussolini noted that while Argentina is also taking steps to localize production of biologics, Brazil will likely be the main player in Latin America for these products because of its growing pharmaceutical market. Although the biologics market is in its infancy and, therefore, specific figures are difficult to obtain, investments in this area have already been officially confirmed. 

 that the company will be building a new facility to produce biological drugs in Brazil. The Swiss pharmaceutical company will invest R$1 billion (approximately US$ 435 million) in a unit located in Jaboatão dos Guararapes, in the Northeastern state of Pernambuco, to produce vaccines against Hepatitis B. 
  Novartis Brazil said this plant will be the company’s first vaccine production site in Latin America. Construction is expected to be completed by June 2014, while production has been scheduled to start in 2016 according to the company. 

According to Novartis, the company plans to export part of its vaccines output from the new plant and gradually transform the unit into a full-scale biologics producer. Novartis and Brazil’s federal government have signed transfer-of-technology (TOT) deals to produce drugs in government-owned facilities, hence, making the country less dependent on imported products and technologies. 

Novartis is not the only company to sign TOT deals with the federal government. The country’s health ministry stated that it is negotiating approximately 27 deals with public and private laboratories to produce as many as 14 biological drugs nationally. The ministry’s objective is to increase the number of locally produced biological drugs for the treatment of breast cancer, leukemia, rheumatoid arthritis, and diabetes among others. According to government figures, the country would save around R$225 million (approximately US$ 97.8 million) a year with local production, using transferred state-of-the-art technology. With so many incentives, perhaps many other eyes will soon turn to the biological products market in Brazil.


Hellen Berger is a business news correspondent based in São Paulo, Brazil.

Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.

Report from Brazil September 2013

Pharmaceutical demand in Brazil continues to grow steadily with sales figures expected to reach $87 billion in 2017 according to IMS Health. It is anticipated that the country will become the fourth largest global market for pharmaceuticals by 2016, leading the Latin American region. 

Brazil has come a long way since its era of high inflation, achieving low national debt, with a rapidly growing middle class hungry for almost anything money can buy, including top-notch electronics, imported automobiles, international vacations, and MBA courses. In addition, access to private healthcare, an expansion of the generic-drug market through government policies, as well as the increased national healthcare services along with better business regulations have attracted the eyes of international pharmaceutical companies. 

"Brazil, compared with its emerging counterparts, presents an important advantage [for international companies] because we are a democratic country with knowledge in the law field, have institutions that work properly as well as [the benefits of] free press and judicial resources," says Antônio Britto, executive president of São Paulo-based Interfarma (a pharmaceutical research industry association). Britto adds that this environment presents Brazil's main differential, followed by the fact that emerging markets have been expanding mainly on common or popular pharmaceutical products amid the rising purchase powers in these regions. 

Pharmaceutical companies around the world are aware that the industry is currently facing a strategic crisis. According to Roland Berger Strategy Consultants, this crisis means that business models must be adjusted given the shrinking margins of pharmaceutical companies as a result of increasing pricing pressure, regulatory changes, and expiring patents.  

Emerging markets show strong growth despite the lower margins, driven heavily by non-patent-protected products. According to data from Roland Berger Strategy Consultants, the biggest growth opportunities for the pharmaceutical industry would be in such markets because these regions are set to rise to nearly 40% by 2016. The firm believes that greater efficiency in research and more collaboration with third-party providers will become increasingly important given that R&D costs have risen by more than 80% worldwide over the past 10 years, while the number of new product launches has dropped by 43%.  

Interfarma's Antônio Britto notes that there has been a rise of global pharma dynamics in the past five years, moving from the US, Europe, and Japan towards emerging markets such as Brazil, Mexico, Russia, and Turkey. Brazil, China, India, and Russia have been experiencing above-average growth rates with emerging markets expected to account for nearly 40% of the global market for pharmaceuticals by 2016. Focusing on high-growth markets could, therefore, be a solution to the crisis for the pharmaceutical industry. Figures from Roland Berger Strategy Consultants show that the market for pharmaceutical products will grow by 4.5% annually on average through 2016, while growth in emerging markets will increase by approximately 12%.  

As the country's economy becomes more stable, Brazilians now face "wealth-related" health issues including obesity, diabetes, and cancer. Consequently, the best opportunities found within the local industry will be from common illnesses as well as complex diseases, says Antônio Britto. 

Another opportunity cited by most pharma analysts is related to the local generic-drug market, which currently accounts for more than 20.5% of generic-drug sales. Analysts agree that the expansion of the generic-drug market in Brazil and the expiry of various blockbuster drugs have attracted international manufacturers overseas. Moreover, the government of Brazil supports local generic-drug manufacturers, and production figures have growing quickly as a result.  

Of the 540 pharmaceutical companies in the country, 90 produce generic drugs. International manufacturers including Roche, Pfizer, and Sanofi-Aventis for example, have developed facilities in Brazil to compete with local companies despite the strong government support towards the domestic players. Nevertheless, the need for research and innovation continues as the region presents many growth opportunities for access and consumption of pharmaceutical drugs and products, according to Interfarma.  

			"Brazil shows important advantages [compared with other countries]; however, there are also issues to be faced," says Britto. For example, the local taxes are an issue to be dealt with when entering the market as well as well-recognized infrastructure problems, which have always been a concern to companies because the transportation infrastructure has not been able to keep up with demands.  

While the local government has in the past invested in this area and is set to invest further to cater for upcoming international sports events that will be staged in Brazil, goods, including pharmaceutical products, still continue to pile up at airports and ports. According to Britto, new players must be prepared to bear the high costs of regulatory delays and taxes, of which Brazil is among the highest in the world, as well as put up with infrastructure challenges that pose difficulties in ports and airports. He also mentions challenges in recruiting highly technical employees for specific jobs due to the country's education deficiencies, mainly in the areas of science, chemistry, and engineering.  

International press reports have stated that the regulations in Brazil tend to be confusing; hence, partnering with a knowledgeable supply-chain provider would be best for new companies entering the local market. In fact, the government has suggested that new companies partner with a local firm to enter the Brazilian market. However, Britto does not believe in a formula that applies to all companies. "It all depends on the type of company and product to be developed in Brazil and it depends on the market it will be competing in," he says.

Britto considers Brazil to be well regulated and states that the system is rigorous. "Brazilian regulation is as good as the best global regulations on average. The problem is not the lack of regulation, but the lack of professionals capable of putting the existing regulation in practice."

It is clear that to succeed in this complex market, pharmaceutical companies will need to rethink their strategies carefully. Roland Berger Strategy Consultants agree that there is no such thing as a generally valid strategy but a multi-dimensional plan to thrive in such an unknown environment.

Hellen Berger is a business writer based in São Paulo, Brazil.

Brazil offers opportunities and challenges for global pharmaceutical companies.

Report from Brazil July 2013

Brazil's regulatory chamber of pharmaceutical products market (Anvisa-CMED) has authorized pharmaceutical products in the country to have prices adjusted by up to 6.31% starting on March 31, 2013, according to Anvisa, an agency that monitors drug prices and gives technical support for the definition of drug prices. One of the agency's attributions is the Executive Secretariat of the Drug Market Regulation Chamber (CMED), which is an interministerial body responsible for drug market regulation and for establishing criteria of drug prices definition and their adjustments.  

 FLAVIO CONCEIÃÃO FOTOS/FLICKR/GETTY IMAGES			

Anvisa, led by the Ministry of Health, has set percentages for raising the price of antibiotics, anti-inflammatory agents, diuretics, and other drugs. Homeopathic and naturopathic products are not subject to such price increase. The cap-price determined will be frozen either for a one-year period or until March 2014. According to the Brazilian Pharmaceutical Wholesalers Association (Abafarma), the percentages vary between 2.70%, 4.59%, and 6.31%, and were stipulated based on the market share of each product in the local market in comparison with generic brands of the same drug. As Abafarma executives note, the only products in Brazil to have price controls are pharmaceutical drugs. 

Since 2003, Anvisa's regulatory chamber has managed price controls of pharmaceutical drugs commercialized in Brazil by setting price-cap standards. The "production" price-cap defines the maximum wholesale price at which a pharmaceutical drug may be sold in the Brazilian market, while the "consumer" price-cap is the maximum price at which it can be sold to the customer at drugstores and pharmacies around the country.     

The regulatory authority defines the maximum price of pharmaceutical drugs through CMED's Resolution 2/2004. New drugs entering the market will be put in categories and priced according to their use and scientific evidence according to the regulatory authority. When considering the price-cap for new pharmaceutical products, the local authority will also evaluate the lowest international price for that product using certain countries as a parameter, including the country where the drug was produced, as well others such as the United States, Canada, Spain, Italy, Portugal, Greece, France, Australia, and New Zealand.  

The study, released in January 2013 by Anvisa, analyzed pricing standards in the past years and concluded that the current pricing regulation has enabled Brazilians to purchase pharmaceutical drugs at prices that are on average 35% lower than the values initially requested by the pharmaceutical industry. The study analyzed cap-prices established by CMED between March 2004 and December 2011 for 1115 formulae/presentations and 433 pharmaceutical drugs.   

According to the management of Anvisa, the prices of pharmaceutical drugs entering the Brazilian market ended up lower than those presented to Anvisa by pharmaceutical companies because of the established price-cap market regulation, which impeded companies from charging higher values. The study evaluated the prices of pharmaceutical products containing new molecules, drugs to be sold in new pharmaceutical forms, and new associations for known active ingredients. The study showed that new associations of active 

ingredients already existing in the country and drugs in new pharmaceutical forms (category V) had a difference of 38% between the final price and the price requested by the industry. Other pharmaceutical products that could not be included in any category established by the government had their prices "reduced" by an average of 35% and 45%. 

For products carrying innovative molecules patented in Brazil and those that have been proven to offer therapeutic benefits compared with drugs already being applied for the same use (category I), the study showed that the final cap-price was on average 19% lower than the value requested by the pharmaceutical industry, Anvisa stated. Other new products that were not patented in the country, or that had not been proven to offer therapeutic benefits (category II), had a reduction of 37% on average compared with the original price suggested. 

Of all the pharmaceutical drugs studied, 45.03% were category II products. New associations of active ingredients already existing in the country and drugs in new pharmaceutical forms (category V) made up 36.72% of all products analyzed. Drugs carrying innovative molecules patented in Brazil and that have been proven to offer therapeutic benefits compared with drugs already being applied for the same use totaled to only 3.24% of all drugs studied. The other "unclassified" categories totaled to 15.01%, according to Anvisa. A relevant aspect of the study was on the number of foreign companies and Brazilian firms that were granted pharmaceutical authorizations by Anvisa for drugs carrying new molecules. According to data from the study, foreign capital firms represented nearly 82% of the total number of companies that had authorizations issued under categories I or II. However, the study showed that there were no domestic companies offering pharmaceutical drugs under category I. 

Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years.

Report from Brazil May 2013

In 1898, an outbreak of Bubonic plague struck the port of Santos in São Paulo, Brazil. A year later, a local bacteriological institute set up a unit to produce anti-plague serum in a government-owned farm known as Butantan, which was renamed the Butantan Serumtherapy Institute in 1901.  

The institute started gaining global recognition as it ventured into research on animal venom, which consequently led to the production of anti-venom. In 1915, the institute was renamed Butantan Institute. Known as Butantan, the institute currently conducts technical and scientific activities in two major areas—the production of serum and biomedical research.  

The institute claims to be Latin America's biggest vaccine producer, with an output of more than 300 million doses every year. Today, Butantan is considered a major contributor to Brazil's public health, having approximately 1700 staff members, including 180 scientific researchers specializing in innovation. 

"I believe Butantan Institute is an important partner to [Brazil's pharma] companies as 80% of all vaccines used in Brazil are produced by this institute," says Irina Kerkis, director of the genetics laboratory at Butantan Institute. Despite its struggles in a globally competitive market, the institute reaches for innovation while balancing research and production according to its researchers.   

In its search for local and global recognition, Butantan has developed major research capabilities at its genetics laboratory, including the expertise to retrieve stem cells from milk teeth. Nelson Foresto Lizier, a scientific researcher working at Butantan's genetics laboratory, says that this project is vital given that stem cells have the ability to generate almost any human cell. The study, which is considered the first of its kind in Brazil, is being developed with "100% Brazilian technology" according to Lizier.  

The development of the technology started in 2004. It was initially privately funded; however, six years later, investment from major public agencies began pouring in according to Kerkis.  

Implications for the pharmaceutical sector

Private pharmaceutical companies in Brazil acknowledge the importance of stem-cell research. "Butantan and the national pharmaceutical industry are major partners and the institute is willing to develop research studies together with the private sector," says Henrique Uchió Tada, executive technical director for the National Pharmaceutical Laboratories Association (Alanac). 

According to Tada, the various potential benefits and applications of the stem-cell project include, among others, treatments for diabetes, heart illnesses, liver problems, multiple sclerosis, brain lesions, Parkinson disease, inflammatory diseases, and the recovery of human skin and organs. "However, the development of related pharma products is still a little far away for the national pharmaceutical industry," he adds. Tada explains that stem-cell studies conducted by national pharmaceutical laboratories focus on a type of treatment that is not considered traditional. He says that treatment is obtained through the retrieval of stem cells from the individual's body and not through a synthetic drug applied for treating an entire population with the exact same illness or disease.  

Several bioethics experts in Brazil believe that there may be a gap between the pharmaceutical industry and stem-cell treatments. The future might not require the use of drugs as we know them, they say. For example, patients would be able to use their own cells to cure diseases, and as a result, the pharmaceutical industry would be affected because of profit loss from the steep drop in sales. Tada, however, believes that pharmaceutical firms could benefit from stem-cell advances if they develop a method that makes use of stem cells in treatment procedures.  

According to both Kerkis and Lizier, the pharmaceutical industry has shown great interest in stem-cell research because of its potential as "biotools" for developing and testing new products. "The development of new drugs through the study of stem cells could become a reality by conjoining findings from pharmacology and cellular biology studies as the variety of substances produced by cultured stem cells could open new doors for pharmacology in general," says Kerkis, whose statement was supported by Lizier.  

Embryonic stem cells, obtained by a special technique developed by Butantan researchers, are already being tested in humans. According to the institute, results from these clinical studies, which involve reconstruction of the tissue that covers the human eye cornea for example, are expected to be reported during the second half of 2013.  

Butantan's biggest finding is that, through the method developed, it is possible to obtain sufficient quantities of cells to be applied in humans. According to Lizier, one of the advantages of working with stem cells from milk teeth is that these teeth are biological materials that are generally discarded and children have an average of 20 milk teeth that are changed during their lifetime. Moreover, the extraction of the internal material from the teeth is simple and not as painful when compared with other techniques. 

With the method developed at Butantan, it is possible to obtain cells that are considered immature compared with other populations of adult stem cells found in other tissues. According to Lizier, the technique uses cells that are similar to embryonic cells, but without the bioethics issues involved or the possibilities of inducing tumor growth during treatments. Using Butantan's technology, researchers can retrieve approximately 100 billion cells from a small fragment of dental pulp. "The figure is big enough for treating up to 100 patients," says Lizier.  

Butantan has scientific proof that stem cells from milk teeth could play an important and safe role in treatments involving bone, cartilage, muscle, and neural tissue regeneration as well as in therapies for immune and metabolic disorders and dentistry. As the research develops, other applications of the institute's technology could prove useful in the near future.  

—Hellen Berger is a business writer based in São Paulo, Brazil.

Brazil's major vaccine producer innovates with stem-cell research.