The Girona pharmaceutical is waiting for news from the EMA, which has been evaluating the formula for months so that it can start marketing

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The Hipra pharmaceutical company, based in Amer, has worked hard to push ahead with a covid vaccine and compete alongside giants in the sector. He was able to develop the drug, the trials showed good results and the company is ready to manufacture millions of doses. However, it has long been stuck in the last step, the approval of the European Medicines Agency (EMA, for its acronym in English). After several setbacks and postponements, it will end in 2022 without being able to go to market. This is the story of the Selvatan company's bet and its biggest bet.


From animal to human health


Hipra was originally a pharmaceutical company based in Madrid , but it was partially acquired by the Catalan veterinarian and chemist Joan Nogareda in 1971 and moved its headquarters to the Selva region. Twenty years later, the Nogareda family gained control of the entire company, which has had a horse in its logo since its inception and owes its name to the surnames of the two military vets who founded it: Hidalgo and Prado. The Nogaredas have been very active in the sovereignist business foundation Femcat, and the president of Hipra, David Nogareda, is a member.



Until before the pandemic, it was dedicated solely to the manufacture of drugs for animals, a sector in which it has achieved very solvent and continuous growth. But Amer's group had been considering making the jump to human drugs for some time, and the pandemic accelerated plans. As I already had extensive experience in animal vaccination, I was not starting from scratch when moving to human vaccines, as the early stages of development are almost identical.


Rehearsals begin


The Spanish Agency for Medicines and Health Products (AEPS) gave Hipra the green light to start clinical trials of the antidote on August 11, 2021. However, they already started them a little later than it was expected The wild group hoped to obtain authorization earlier, around June, and carry out the first tests in October, but following the predominance of variants different from the Wuhan original, it was decided to extend the deadlines and open the range of protection



Last summer, the Josep Trueta Hospital in Girona and the Clinic in Barcelona received hundreds of volunteers to test the medicine. The Catalan pharmaceutical company chose the first thirty, who, among other requirements, had to be between 18 and 39 years old and not have had the virus or received any other covid vaccine. Since the first phase did not present any safety problems, the AEPS authorized to proceed to phase two of the clinical trial, in which more than 1,100 volunteers participated. This time the volunteers already had to have the double dose of the BioNTech/Pfizer vaccine.


Stuck on the last step


After successfully completing the third and final phase of the clinical trial, which began in February this year with more than 3,000 people and seven Catalan hospitals involved, the EMA began studying the antidote last March. The European Union Medicines Agency's review did not set a deadline, but instead assessed the data as Hipra collected and submitted it. Now, although the company from Selva handed over all the documentation—thousands and thousands of pages—at the end of October, it still does not have the final green light.


Hipra had hoped that the EMA would respond quickly and receive the go-ahead around March, but it has had to postpone the forecasts because it has been asked for additional information about the drug and its production process. In the last press conference held by Hipra in Brussels, the company explained that it had sent the last required details and that it estimated that it would have the authorization at the end of November, just in time to join the winter vaccination reinforcement campaign.


However, the Girona company has had no further news from the EMA since then. Hipra sources point out that the "emergency context" in which other covid antidotes that are already on the market were evaluated and approved is not the same as now, and they remember that "evaluators have a lot of work and documents to to study" and that vaccines against covid have ceased to be such an "urgent and priority" issue as it had been some time ago.



Prepared to manufacture millions of doses


Despite the fact that the size of Hipra is not comparable to companies like Pfizer, the Girona pharmaceutical company has grown a lot in recent years and right now has around 2,500 employees - around 1,500 of whom are in Catalonia - and around forty subsidiaries spread out in countries like Canada, the United States, China, Brazil or Peru. In fact, the company assures that a week after receiving the yes from the EMA, it could start manufacturing doses and calculates that, in the first months, it could produce about fifty million and, in the long run, about a thousand millions a year.


By now, up to fourteen European Union states, including Spain, France and Austria, have already agreed with Hipra to purchase up to 250 million vaccines. This contract, however, is not like those signed by Brussels with Pfizer-BioNTech, Moderna or AstraZeneca during the first months of the pandemic, which already bought the doses even before the EMA authorized them, but simply each country has the right to acquire them on a priority basis. Beyond Europe, the pharmaceutical company assures that the antidote has aroused interest in countries all over the world, especially in Asia and Latin America.


The vaccine remains competitive


Although Hipra will arrive on the market later than other pharmaceuticals, the company maintains that it has characteristics that will make it more competitive. It will be slightly cheaper than those that have been administered in the European Union until now: it will cost around 10 euros, and the others, according to Unicef, cost between 12 and 21 euros per dose. In addition, the company claims that it provides superior immunity for longer and causes fewer side effects, and can be stored in a normal refrigerator without the need for ultra-freezing like ARN's (Pfizer and Moderna).


The company believes that these factors could make it easier to sell to poorer countries that have less logistical capacity to get the covid vaccine to all their citizens. On the other hand, because it has fewer side effects, the company points out that people in richer countries now think twice before taking booster doses for a headache or a fever they might have for a few hours, she will probably be more willing to get the Catalan vaccine.