04/22/2026 | César Ferro | Panorama Farmacêutico

https://panoramafarmaceutico.com.br/cristalia-promete-investir-o-que-for-necessario-na-polilaminina/ 

The laboratory has already allocated approximately R$ 150 million for the development of the molecule

Even after investing R$ 150 million in the development of polylaminin, Cristália continues to spare no effort in advancing the molecule through clinical trials. In an interview with Valor Econômico, the pharmaceutical company’s founder and chairman of the board, Ogari Pacheco, stated that the laboratory will contribute “whatever is necessary for the success of the innovation.”

The drug, which aims to regenerate spinal cord injuries, has sparked mixed reactions. On one hand, patients are seeking access to the experimental treatment through legal action. On the other, scientists outside the project are raising questions.

Led by scientist Tatiana Sampaio of the Federal University of Rio de Janeiro (UFRJ), the research has been supported by the company for eight years. The company’s funds financed the study and covered the cost of administering the drug to approximately 30 patients under compassionate use—when Anvisa authorizes its use in specific cases, even before formal approval.

Polylaminin patent is the first point of controversy
Cristália filed for a patent for the polylaminin manufacturing process at the national level in 2022. The following year, the application was also filed abroad, in markets such as the U.S., Europe, India, China, South Korea, and Latin America.

These applications are still under review, with no timeline for a decision. “Today, we are covered by this application, which provides us with protection both here and abroad,” says Rogério de Almeida, the laboratory’s vice president of research and development.

On the other hand, UFRJ lost the international protection it had applied for in 2007—about ten years later—due to failure to pay maintenance fees. That exclusivity specifically protected the molecule. Nationally, the patent expires in 2027.

Publicity for the project raises questions
Another controversy involving polylaminin concerns the way the project was publicized. For most researchers, there is no doubt about the molecule’s efficacy or Tatiana’s competence as a researcher, but the publicity is said to be generating “disproportionate expectations.”

In a joint letter, the Brazilian Academy of Sciences (ABC) and the Brazilian Society for the Advancement of Science (SBPC) stated that the case highlights “strengths” and “weaknesses” in how Brazil innovates in the field of health.

“Spinal cord injury is a clinical condition; each patient has their own motor and emotional characteristics, which influence recovery. There is also physical therapy, which plays a fundamental role in this type of recovery and is being neglected,” says Dr. Linamara Batistella, full professor of physical medicine and rehabilitation at the University of São Paulo (USP) School of Medicine and founder of the Lucy Montoro network.

For the specialist, promoting the drug as a general treatment is risky due to the specificities of the tissue, which vary from patient to patient. “It is possible to deny compassionate use even with preliminary injunctions, because the risk assessment—a step following Phase 1 of clinical research—has not yet been conducted,” she adds.

In January, Anvisa approved the start of this phase of the study, four months after Cristália and the researcher presented the drug to the press as “a protein capable of regenerating bone marrow cells, partially or fully restoring mobility.” “The question that remains is: should this process have gone to the media and taken up all that space, or should it have waited a little longer?” asks Francilene Garcia, president of the SBPC.

Cristália has already received about 8,000 requests for compassionate use
The number of patients using polylaminin may seem small, but it does not reflect the number of requests for compassionate use that the pharmaceutical company receives. To date, there have been about 8,000 requests, but most did not meet the predetermined conditions, such as injuries occurring between 72 hours and 90 days.

The laboratory has already registered approximately 170 people, and 58 received the medication as of April 16. The process involves a pre-selection conducted by the company, which submits patients for review by Anvisa. The agency is expected to review the requests within two days.

Compassionate use is free of charge to the recipient, as it is funded as a donation by the manufacturer. Through this agreement, it has been possible to reduce the number of requests for treatment through the courts.

According to the vice president, if clinical trials maintain the 75% success rate that has been observed, the final registration application should be submitted in about a year. At the same time, the company is building a biotechnology plant in Itapira (SP), with an estimated investment of up to R$ 400 million. “All of the polylaminin that will be produced will be at this facility,” he says.