Success of Vonau Flash drug points way to university
The royalties from Vonau Flash, a motion sickness drug, earn USP more than its other 1,298 patents combined. What lesson can universities learn from this?
"It's not that way. You need to publish more." Since the mid-1990s, when he became a professor at the University of São Paulo's Faculty of Pharmacy, Humberto Gomes Ferraz heard this admonition from colleagues and some of his bosses. The relationship has begun to change in recent years. "Today, few people have the courage to criticize openly, because what I did worked," he says.
And rightly so. Ferraz is the author, together with the pharmaceutical laboratory Biolab Sanus, of a patent that made it possible to create the anti-sickness drug Vonau Flash. Last year, this patent alone accounted for 58% of all the royalty income of the country's largest university. In total, the 1,299 patents held by all of USP's departments brought in 2.49 million reais; Vonau Flash was responsible for 1.44 million reais of that amount. And the numbers are set to grow. In the first three quarters of this year, Biolab claims to have already transferred 2.29 million reais to the university, a 59% jump in revenue, with one quarter still to go.
USP will be able to use this source of income until 2028. The patent was only granted this year, 13 years after the application was filed with the National Institute of Industrial Property (INPI). According to the law, a patent is valid for 20 years from registration or ten years from approval, whichever is longer. For the Vonau Flash, this is the second case. Until now, it had been sold under the protection of a provisional patent, which has ensured Biolab a sensational trajectory: in 12 years, Vonau has dislodged Plasil from market leadership and is experiencing growing sales, with projected revenues of 132 million reais this year and 160 million next year. What allowed Vonau Flash to rise was precisely the object of the patent that Ferraz holds jointly with Biolab: the medicine dissolves in the mouth and can be swallowed without water.
The advance is not just in convenience. If it were only that, it would be enough: a more palatable pill, for those with children, can be the difference between a medicine being swallowed and a medicine being refused. But there's another feature that Biolab has translated into the name Flash. "The advantage is speed," says Dante Alario Jr, Biolab's scientific president. "In the stomach, the medicine takes 15 to 20 minutes to act. If the person is suffering from nausea, vomiting expels the product before it takes effect." Dante saw the potential of such a drug during a trip to England. There, the drug Zofran was sold for something like 200 dollars a box, containing ten pills. The active ingredient, Ondansetron, was patent-free. It would be difficult to replicate the process of making the tablet soluble in the mouth. The British used lyolization (dehydration in the laboratory), but it was too expensive. It was this problem that Dante presented to Ferraz in 2004.
Ferraz was a different professor from the average: he had always been interested in products and had always worked with the private sector, something that is still viewed with suspicion in academic circles. His vocation for pharmacy began, according to him, as a child in the Minas Gerais town of Cataguases, when he sucked on a yellow pill and realized that it was white inside.
From then on, his interest only grew: he was a child who read medicine leaflets. He went to university in Juiz de Fora, where his family lived, and worked for a year at the Eli-Lilly laboratory. In the 1990s, he did a master's and then a doctorate at USP, where he also became a professor. Ferraz's doctorate was sponsored by the pharmaceutical company EMS, which was interested in the tests needed to launch the first generic drugs in the country. "It was a combination of academic interest, company interest and national interest," he says.
The project was modest, something like 100,000 reais, according to the professor. To develop the product, Ferraz began to carry out various dissolution tests. They had to get the taste right, the dose of the substance to be released in the mouth right, the right dose to release in the stomach when the pill was swallowed. It was a back and forth job: "We tested it here in the lab, then passed on the production conditions to the company," he recalls. The process took a year of testing plus two years for registration with the National Health Surveillance Agency (Anvisa). From Biolab's point of view, the result could hardly have been better. "We launched a box of Vonau Flash at a tenth of the price of the English product," says Dante. "We spent six or seven years fighting with Plasil, which was the clear market leader." Today, according to his calculations, Plasil has fallen to 10% market share. Vonau has 40%.
Taking into account the entire period since the product began to be sold, USP received 8.66 million reais by the end of last year, just for the collaboration of one of its 5,900 professors with a company. Of course, this money is a long way from solving USP's financial difficulties, whose budget is around 5 billion reais (three orders of magnitude higher). But it's tempting to think how much the university's revenues could increase if it were to get closer to the world of business.
Ferraz's success is a case in point. His Pharmacotechnical Development and Innovation Laboratory had six people in 2009, and today has 23. The equipment is more modern and the space is privileged, all thanks to the results of his partnerships with companies. "I've always been different. I've always thought about the market, about management." In the university culture, he says he was somewhat marginalized. He didn't become a full professor, a step up in academic status. "I've had hierarchical superiors say: 'What you're doing isn't right, do what the university wants'. And what the university wants, according to them, is for us to publish articles." Ferraz has almost 80 publications. But applied research isn't worth the same number of points in the rankings as pure research.
"I don't think there just has to be applied research. But I think there has to be applied research as well," he says. "How is it that the largest and most respected university in Brazil, where a phenomenal amount of basic and applied science is produced, has such difficulty turning its inventions into products sold in partnership with industries?"
This is, to a certain extent, the path that the university is now planning to follow. To a certain extent. "We mustn't forget that the university exists to generate and transfer knowledge," says Professor Antonio Carlos Marques, who was appointed coordinator of the USP Innovation Agency this year. "Most of this knowledge the university transfers via classes, by training people."
USP also operates within certain limits. For example, it does not profit from services for public entities. The research that helped invent the ethanol combustion engine didn't lead to licenses; the development of the Nota Fiscal Paulista didn't lead to patents. "USP has more than 7,000 agreements, and only about 400, far less than 10%, involve intellectual property and money," says Marques. "We also have four business incubators and we're building a fifth. There are hundreds of incubated companies." According to Marques, patents attract attention, but they don't bring in as many resources anywhere. "Even at the University of Florida, which created a hit like Gatorade isotonic, royalties are between 10% and 20% of revenue.
Nor is USP that far behind model institutions. The 53 patents that USP generated in 2017 would put it in 43rd place in the international patent ranking. This is much less than the first-placed University of California, with 524 patents, or than MIT, with 306, but it is more than the University of Tokyo (48) and almost the same as Yale (51). Which only puts the matter in its proper place. It doesn't matter so much how many patents are produced, but their quality. And this is where USP is trying to improve, according to Marques. "USP has around 1,300 active patents today. But how many are licensed? In other words: I have 1,300 answers, but I don't have the questions," he says. "The philosophy we're implementing now is to stop proposing answers and look for the questions."
In July, the university launched the Technology Partners Program to seek out the demands of companies. On the other hand, there is an effort to contact departments and understand the offers that exist at the university. Preparations are also being made to adhere to the Legal Framework for Science, Technology and Innovation, a law that allows public universities to share space with the private sector and establishes rules so that a professor can leave their chair, explore a market opportunity and then return.
"In many countries, the first thing you have to do when you become a teacher is start your own company," says Ferraz. "Here it's forbidden to receive more than your salary." In his case, the income from Vonau's patent is shared with USP, the department, the innovation agency and the laboratory he runs. "But I have nothing to complain about," he says. His laboratory continues to work on projects with the private sector. It's not just because of the possibility of bringing welcome resources to the university. Marques says that this keeps him constantly learning. And the students are prepared to face the practical reality of the market where most of them will work.