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Developing a global vaccine supply

Having established itself as a center of excellence for the development of biotech products, Sinergium Biotech is fast becoming the go-to place for vaccine supplies across Latin America.

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Jun 01, 2017
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Sinergium Biotech specializes in the high-tech manufacturing and supply across Latin America of highly complex biotech products and vaccines. Its innovative production model, which involves part­nerships with multinational vaccine companies for cutting-edge technology, enables a rapid response to endemic infectious diseases while fostering autonomy.

It was the realization that Argentina was very vulnerable to pandemic flu that first sparked the concept of Sinergium as a solution. More than 5,000 people were dying every year from respiratory dis­eases alone, and worldwide vaccine availability at the time could not satisfy the demand that would emerge during a pandemic of flu. The country was continually reliant on imports, with no know-how or vaccine investment.

So in 2009, two Argentine companies, ELEA (the country’s third-largest pharma) and Biogénesis Bagó (the world’s largest producer of vaccines for foot and mouth disease) formed Sinergium Biotech SA. The idea was that Sinergium would—under a deal with multinational pharmaceutical firm Novartis—manu­facture Novartis’s influenza vaccine in exchange for full technology transfer to Argentina, including primary production of the antigens by Sinergium and self-sufficiency in the long term. The state later declared this concept, an idea of interest through a presidential decree.

The Argentine state put local flu vaccine produc­tion out to a public international tender, offering ten years of exclusive purchase in exchange for priority delivery in the event of a pandemic, as well as the construction of a manufacturing facility. It set stiff penalties for failure to deliver the vaccines and for construction delays. Sinergium won the contract and, in 2010, began building a state-of-the-art facil­ity capable of producing vaccines and other biologi­cal products under good manufacturing practices (GMP). Production of Novartis’s inactivated flu vaccine began in 2013, and today the company produces between 9 million and 12 million doses of trivalent influenza vaccine per year—enough to vaccinate the at-risk population (Fig. 1).

“The idea was to leverage the country`s govern­ment procurement power to bring technology to the country,” explained Fernando Lobos, Sinergium’s director of business development. “It has worked, and we are building momentum.” Sinergium has expanded the model, striking similar deals with Pfizer for a 13-valent pneumococcal conjugate vaccine and with Merck for a human papilloma virus vaccine. “Our manufacturing facility, which meets the highest stan­dards in construction, processes and equipment, has an extra capacity of up to 30 million doses, enabling us to secure these major deals with leading compa­nies. At the same time, we are learning from their huge experience and expertise,” added Lobos.

Figure 1: Sinergium Biotech’s ViraFlu in production.

Encouraging vaccine uptake

With a strong public health ethos, Sinergium not only supplies vaccines but also provides bespoke sup­port to increase their uptake, as part of the contracts with the state. With the flu vaccine, for instance, it set up a call center and works with opinion leaders to coordinate promotional strategies and key mes­sages. For the pneumococcal vaccine, Sinergium built cold chambers in each province in Argentina to strengthen cold chain distribution. “Our commit­ment is with the Argentinean state to improve the immunization results accomplishing the actions requested in the tenders, impacting in uptake rates high,” said Lobos.

Results are impressive. Influenza vaccine cover­age, for example, is now above 80% in Argentina (in the United Kingdom it is less than 75%, and it is much lower than that in other European countries), and cases of bacterial pneumonia in children above 5 years old have diminished by 50%.

Meanwhile, by using its platform to formulate, fill and package in-licensed products (with or without suppliers’ branding), Sinergium is fast becoming the go-to place for access to Latin American mar­kets. Its supply portfolio currently includes vaccines against polio and varicella, the pentavalent vaccine, Bacillus Calmette-Guérin (BCG) for bladder cancer, and production for third parties of other biologics, such as monoclonal antibodies (e.g., rituximab and bevacizumab) and other recombinant proteins (e.g., erythropoietin).

“We have built a center of excellence in biotech production and have a high reputation with regula­tory authorities,” said Lobos. “We are capable of fulfill­ing domestic requirements of the national state for the public market and have significant potential to export regionally, which in turn will benefit the coun­try’s trade balance.”

The next phase is to export and expand the busi­ness in Latin America, Europe and the Middle East, and to tackle other endemic diseases such as Zika virus, chikungunya virus, yellow fever and others. “We are also building a new manufacturing site of 5,000 m2 for antigen production, the next necessary step for developing our own, broader portfolio for the longrun,” said Lobos.

In April 2016, Sinergium struck a deal with Protein Sciences Corp (USA) to codevelop a vaccine against Zika virus and, together with other companies from Mexico, Japan and Brazil, plus the Mundo Sano Foundation, is expected to start phase 1 clinical trials in August 2017.

Partnering with Sinergium

Sinergium Biotech is interested in establishing tech-transfer agreements for additional vaccines needed for Latin America and the Middle East. Additionally, with its network of sites across these markets, the company is ideally positioned to in-license vaccines and other prequalified World Health Organization or appropriately approved products related to infec­tious diseases (antivirals, diagnostic kits and so on) for part processing and distribution across the region.

“Latin America and the Middle East are interesting markets but difficult to access for many companies,” said Lobos. “We have headquarters in Argentina, are well recognized across the regions and are very flex­ible with the business model needed in each case. We believe in collaboration and partnerships—it’s our essence and a way of bringing much-needed products to this part of the world.”

Contact

Fernando Lobos,
Director, Business Development
Sinergium Biotech S.A.
Buenos Aires, Argentina
Tel: +54 (0) 11 3220-7300
Email: fernando.lobos@sinergiumbiotech.com
Website: www.sinergiumbiotech.com

Go to the profile of Sinergium Biotech S.A.

Sinergium Biotech S.A.

Sinergium Biotech is an Argentine biopharmaceutical company specializing in the research, development, production and marketing of high complexity vaccines and biopharmaceuticals. With unique characteristics worldwide, it carries out an innovative productive model of strategic alliances with national and international laboratories that allows: the transfer and availability of state-of-the-art technologies, autonomy in production and provision of strategic products that were previously to be imported, Generation of new sources of work with highly qualified professionals, the replacement of imports and the generation of significant export potential.

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