Biocuba is optimistic about a future without barriers

SAO PAULO, Brazil – Now working without the hurdle of a trade embargo, Cuba's largest biopharma group is forging ahead with renewed optimism about the future.

During the recent BIO Latin America conference, a representative from Biocuba Farma, of Havana, said that positive outlook was built since the administration of U.S. President Barack Obama lifted a long-standing embargo against the Caribbean island.

"It is very important to say that we have a very high potential to grow with the opening of the U.S.," said Yodira Pérez, legal and commercial advisor from the commercial policy directorate of business and international cooperation at Biocuba.

Pérez shared with an audience of participants the perspectives for the publicly owned scientific holding that owns 32 companies in the Caribbean country. Biocuba Farma employs 21,768 workers. Out of them 6,325 hold higher education degrees, 1,170 masters in science degrees and 262 have PhDs.

"We have a very high innovative capacity; more than 100 research and development projects, international recognition all over the world and we have validated comprehensive health programs, not only in Cuba, but also in Venezuela and in Brazil," she told the audience.

In an interview with BioWorld Today, Pérez said that Biocuba's perspective is to increase the impact of Cuban biopharmaceutical products.

And to achieve that objective, the country is working to offer the international community a strong legal framework to guarantee and capture foreign investment.

"Our country opened the policy to allow the investment in the biotech sector," she explained. "Biocuba Farma is working in the same areas that biotech is looking for. We have 91 [biotech] products," said Pérez.

The company currently manufactures 1,099 products out of 78 manufacturing facilities across the country.

The state-owned company is immersed in important developments around the world. Nowadays Biocuba has a partnership with Daiichi Sankyo Co. Ltd., of Tokyo, in a clinical trial currently in phase III, for the use of nimotuzumab, recombinant humanized monoclonal antibody for head, neck and esophagus cancer.

"We are trying this indication for stomach cancer," said Pérez.

"We´ve got a lot of expectations with this one. The clinical trial should end next year, but it takes about two years of follow-up," said Pérez. "The advisory committee has not recommended halting the trial and that means that result are going well, or at least, the trial is not affecting the patients."

Meanwhile, Biocuba is moving forward in other fronts.

With the announcement of the end of the embargo, the Cuban company is partnering with Roswell Park Center, from Buffalo, N.Y., to jointly develop Cimavax-EGF, a vaccine against lung cancer that has shown positive results in Cuba. (See BioWorld Today, June 24, 2015, and Oct. 28, 2016.)

In fact, last week the U.S. FDA approved the recruitment of volunteers for the clinical trial.

"We're at an early stage in the development of this vaccine, which has never before been given to U.S. patients, so we have a lot to learn through this study, but the evidence so far is encouraging," said Grace Dy, chief of thoracic oncology in the department of medicine at Roswell Park.

And the U.S. is not the only partner the Cuban company has in mind.

It is also in the process of registering its Heberprot-P to treat diabetic foot ulcer in Russia. The product is already registered in about 20 countries around the world.

"We'll start next year a clinical trial for data validation in Brazil," said Pérez. Heberprot-P is one of Cuba´s best known medicinal products.

And despite the ongoing crisis in Brazil that is also affecting the biotech sector, the Cuban biotech company is willing to expand its footprint. (See BioWorld Today, Oct. 28, 2016.)

"We've got a company in Belo Horizonte and we are thinking on opening a new branch in Brazil, but we have not yet decided in which state it will be," Pérez said. "However, the idea is to increase the holding´s presence here."

Cuba is making great efforts to attract foreign investment in the biotech sector.

"Cuban biotech is open to the world," said Pérez. "We've got a very important zone for the development of biotechnology in Mariel, with a special legislation in Cuba to promote the foreign investment."

The Cuban message to foreign investors is that it will treat them with special care by offering taxation incentives as well as investment guarantees to help in the development and growth of the Cuban biotech sector.

"What we want is to build productive facilities to keep opening to the world, to keep increasing our research and development capacity, as well as our production capacity and also to keep growing from a technology perspective," said Pérez.

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