In recent months, scientist Tatiana Sampaio has become a celebrity. After about 30 years of studies, her discovery, still in the testing phase, has enabled quadriplegic people to move again, and some even to walk. If approved, the medication could change the lives of millions of people around the world. But not only the patients.
Polylaminin, discovered by a biology professor at UFRJ (Federal University of Rio de Janeiro), promises to radically change the history of the Brazilian pharmaceutical company Cristália. The laboratory has been investing in Tatiana's research since 2018 and has already allocated more than R$ 100 million to the development of the drug. And, while awaiting authorization from Anvisa (Brazilian Health Regulatory Agency), it is preparing for an exponential leap. After all, it has patent applications in Brazil and worldwide.
“I am fully aware that polylaminin will be a major star for the company. It will be transformative and will change the laboratory's level,” said Dr. Ogari de Castro Pacheco, co-founder and chairman of the board of Cristália, in an interview with NeoFeed.
Not surprisingly, Cristália, which is projected to have a revenue of R$ 4.5 billion in 2025, is expected to announce this Monday, February 23rd, the purchase of a manufacturing unit for approximately R$ 500 million. NeoFeedhaslearned that this is the Takeda laboratory's factory in Jaguariúna, in the interior of São Paulo state. The investment is intended to meet the demand that Cristália will face.
“My expectation is that the final registration will come out between the end of 2026 and the end of 2027. Until then, I will continue producing at maximum capacity. I can't keep waiting,” he says. “If Anvisa authorizes it tomorrow, I want to be able to supply the medication right away.”
Although further steps are still needed in clinical studies, Cristália has already been storing the produced active ingredient as if it were already about to be launched on the market.
Thus, the company has been stockpiling the active ingredient for two years in a cold chamber at a temperature of minus 20 degrees Celsius at the company's main factory in Itapira (SP). In just a few days, the laboratory is able to transform the raw material into the actual medication and have it ready for distribution.
In this regard, Cristália has already begun talks for international distribution agreements, mainly with companies in Europe and the United States. The local partner will be responsible for the regulatory approval strategy and the commercialization of the drug in the country.
In Brazil, the co-founder of Cristália hopes that the federal government will include polylaminin in the list of medications provided by the Unified Health System (SUS) soon after its final registration with Anvisa (the Brazilian health regulatory agency). He also hopes it can be sold directly to public hospitals, primarily municipal and state hospitals, through emergency contracts.
The businessman does not reveal the cost of the medication, but says that, for the sake of fairness, it is important that the government finances the acquisition. "It's a matter of public health. Otherwise, we would have something unfair, where some could pay and others could not. That's why I believe the SUS (Brazilian public health system) will fund the medication."
As a clear sign that the release will indeed come much sooner than the conventional timeframe, Anvisa also authorized the compassionate use (exceptional release of the drug) of polylaminin in patients who met the conditions according to clinical studies, based on an assessment of their medical condition.
As of last Saturday, February 21st, 57 requests for the medication had been made, and 24 applications of polylaminin had already been performed on patients in Brazil. On Sunday, February 22nd, the Cristália medical team performed five more surgeries on patients eligible to receive the innovative medication.
The hope is to achieve results like those of Bruno Drummond, patient number 01 of the polilaminina program. He became quadriplegic after an accident in 2018. Today, he has regained all movement and can share his daily routine on social media, including workouts at the gym.
However, there are caveats, as with any experimental treatment. In this case, polylaminin is not suitable for everyone with a spinal cord injury. It is important, at this stage, that the application be done within 72 hours of the injury. That is why, at this time, it is not indicated for patients with chronic injuries, older than 90 days.
According to the laboratory, at the end of this initial three-day period, scar formation and other biological processes may hinder the effectiveness of the medication.
With no debt, Cristália ended the year with R$ 5 billion in cash. And a significant portion of these resources will be used to expand polylaminate production. "I will spare no effort and will spend everything necessary to guarantee the product. If I need to spend R$ 2 billion to build another factory, I will do it," says Pacheco.
That's precisely why the company decided to buy an already-built factory. "Since I'm at the limit of my capacity, this plant will temporarily get me out of this situation. I'll be getting a car that's already running, with a driver and all the employees. This shows that we are preparing for the enormous demand that will come," says Pacheco. "I'll now have the breathing room to expand production."
Today, Cristália has nine factories in Brazil, both for the production of medicines and raw materials, in the states of São Paulo and Minas Gerais. The company operates in three areas: hospital (with products such as anesthetics), pharmaceuticals, and the ophthalmological line. It currently has more than 350 medicines in its portfolio, with approximately 500 pharmaceutical presentations.
According to Pacheco, plans also include the construction of another unit near the main factory in Itapira by 2026, exclusively for the production of the active pharmaceutical ingredient (API), the main component of the medication.
The investment for this new factory, which should take between a year and a half and two years, should not be less than R$ 400 million. “I have already received the studies and we are finalizing the project. The idea is to create this autonomous unit for this purpose. We are still defining the budget, but it will fit within our means,” he states.
In addition to the growth potential that the innovative drug will bring to the pharmaceutical company on its own, the trend, according to Pacheco, is that the emergence of this new global market will help expand sales of Cristália's entire portfolio.
“If I can produce a unique medicine in the world, it’s not difficult to see that this issue will extend beyond polylaminin. People will understand that Cristália has many other good products. In practice, this will boost sales of our other medicines,” says the co-founder of Cristália.
Last year, the company opened a factory in Montes Claros, Minas Gerais, with an investment of R$ 300 million, to produce botulinum toxin, Botox, used for aesthetic and therapeutic treatments. It also plans another plant in the city to increase the production of biopharmaceuticals.
Medicine made from the placenta.
Polylaminin is produced by extracting a protein that the body already produces, laminin, which is obtained from the human placenta. To do this, the company collects these placentas from hospitals in Itapira and surrounding cities. One placenta is enough to produce at least three vials of polylaminin.
“We take care to analyze the prenatal care of placenta donors, because the pregnant women cannot have contracted any viral infection that could cause contamination. It is only used after all the tests have been carried out,” explains Pacheco.
And it is this extraction process that was created by Cristália. With the laminin molecules separated, a chemical reaction called 'polymerization' occurs, and that is when it actually transforms into polylaminin. "Today we master this technique with ease."
Before Cristália arrived, the researcher's tests were conducted using imported laminin in a kind of tea bag. Initial results were promising, and the laboratory refined the technique, developing it nationally, precisely so that it could be applied to humans.
With the advancement of studies and the increase in the production of raw materials, the trend, according to the president, is that this area for placenta collection will grow significantly and reach the main hospitals in the city of São Paulo, such as the Hospital das Clínicas.
"Obviously, at some point it will be necessary to attract other hospitals. But this will grow gradually. I can't accelerate it too much," he says.
Does the patent expire or not?
Although Tatiana Sampaio recently stated that a national patent will expire soon and the international one was lost due to non-payment by UFRJ, Pacheco assures that there is no risk of Brazil losing its exclusive production rights to polylaminin.
Currently, Cristália holds the exclusive rights to produce the active ingredient. According to him, the company applied for the national patent in 2022 and the international patent in 2023. This means Cristália will be able to produce the medication independently until 2042 in the Brazilian market and until 2043 for international sale.
"We have applied for a patent for the manufacturing process and the finished product. We have extensive experience and hold more than 140 international pharmaceutical patents. I can guarantee that polylaminin is protected," says the president of Cristália.
Pacheco also says that polylaminin could benefit patients with other diseases. To that end, the president of Cristália has already revealed that there is an intention to soon request registration from Anvisa (Brazilian Health Regulatory Agency) for testing other functionalities, which he prefers not to disclose yet.
"If it promotes regeneration wherever this type of problem exists, I can use polylaminin, not just in the bone marrow. It may have other uses."
