Did you know that an anti-nausea medication accounts for 90% of the royalties received by USP?

https://bit.ly/2Zw7P3h | 08/19/2019
08/19/2019 — Many people assume that research studies conducted by Brazil's public universities are of no practical use. Well, you should know that one of these studies conducted by the University of São Paulo (USP) found the "solution" to nausea and vomiting and has brought a return of around BRL 10 million in the last 13 years.

Have you heard of the Vonau Flash? It is a medication whose patent was awarded to USP last year, and which has become its largest ever source of royalties (payments received for the right to sell a product), accounting for approximately 90% of the fees earned by the university to date.

That statistic was provided by Professor Marcos Martins, coordinator of the university's innovation agency, Auspin. In other words, the result of a single research study is generating more money than all the other patents owned by USP.

The university currently has 1,299 patents involving technologies and/or products developed by different departments. Data from Auspin show that royalties earned through exploitation contracts reached BRL 3.44 million in 2018, with Vonau leading all other products.

Why has Vonau been such a success for USP?

The financial success of Vonau Flash is due to two outstanding features: it does not cause sleepiness and it dissolves in the mouth. Consequently, absorption is faster than with pills that need to be swallowed, says Professor Humberto Gomes Ferraz, the pharmacist who led the drug's development.

The research study of what would become Vonau Flash began almost 15 years ago and relied on the financial support of Biolab Farmacêutica, an organization that owns part of Vonau's patent and exclusive marketing rights.

"We knew that there was a demand in Brazil for an anti-nausea and anti-vomiting drug that would dissolve in the mouth, but we also had to make sure that the production technology was much cheaper than abroad. That's why we sought out the university," recalls Dante Alário Júnior, Biolab's Chief Scientific Officer. The amount invested in the Vonau Flash research study was not disclosed.

Experts explain that the patented innovation involved improving the medicinal properties of an existing substance — ondansetron — and using a cheaper technology for its production.

The issue with some anti-vomiting and anti-nausea medications administered orally is that the fluid needed to take them can cause even more reactions. As a result, they are usually vomited right after administration. Consequently, the medication cannot take effect. Vonau also acts faster.

More than BRL 135 million in revenues for the company

The contract between USP and Biolab was signed in 2005. The following year, after the drug was authorized by Anvisa (the Brazilian Health Regulatory Agency), it began to yield results for the institution and the company. A fixed percentage (unspecified) of each box of the drug sold is passed on to the university.

According to Biolab, the company's earnings from Vonau Flash in 2018 stood at BRL 135 million. For 2019, it expects to bring in between BRL 160 to 165 million — solely from this USP-developed product. "For Vonau Flash alone this year, I have to pay more or less between BRL 3.5 to 4 million," says Alário Júnior. That amount makes up roughly 2.5% of the company's revenues.

"There's no miracle in research. You have to seek out investment. Partnerships are fundamental to both sides. The university is an innovation partnership. I can't just watch all of this knowledge being developed here and not let it reach society due to a lack of resources."

Amid budget cuts at Brazilian public universities, Professor Ferraz stresses that initiatives such as patents can be a valuable alternative to budget control. In addition to the amount invested in the laboratory itself, the university can channel the incoming funds towards equipment, scholarships and other research studies that are costly to the institution. "I think that the partnership between the university and private enterprises could — and should — be much bigger than it is today.

I think everyone would gain from this, because companies would gain specialists who would help them develop solutions, processes and products, while the university would gain problems to be solved and sources of funding to solve them," Martins concludes.

How does the royalties division work?

Under the agreement with the USP, the fees are paid to the dean's office (the finance department), which redistributes them to:

USP overall
The university's Innovation Agency
The School of Pharmaceutical Sciences
Deinfar (The Pharmaceutical Development and Innovation Laboratory)
The patent's inventor (the leading research scientist)

The percentage for each was not specified

Under current Brazilian regulations, USP can collect royalties associated with the sale of the drug until 2028. Afterwards, the agreement with Biolab provides that the company will pay a reduced fee.

Although it has become a profitable product for the university, Ferraz criticizes the delays in the patent process. The application was filed in 2005, but USP's and Biolab's rights were not granted until March 2018. "It took over 13 years. That's a long time and, unfortunately, this has become routine in Brazil."

Commercialization of the drug up to that point relied on the "expectation of rights." Imagine that you have a product with a patent under review. If anyone wants to sell it during this process, you can only file a lawsuit once the patent has been granted (even if that takes years). A company will hardly ever want to take that risk.
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