Madrid, 31 March 2023
31-03-2023.- The Spanish pharmaceutical group Insud Pharma has just announced a collaboration agreement with the biotech pharmaceutical company HIPRA to accelerate and facilitate the access to the COVID-19 vaccine in different countries in Europe and Latin America.
As a result of this agreement, Insud Pharma’s division, Exeltis, which has more than 4,000 employees worldwide, will be responsible for distributing the vaccine in Argentina, Uruguay, Colombia, Mexico, Chile, Peru, Paraguay, Venezuela, Bolivia and Ecuador. In Europe, the alliance between HIPRA and Exeltis will provide market access services for Poland, Portugal, Norway, Sweden, Iceland, Denmark and Finland.
This agreement is announced after yesterday 30 March, the European Medicines Agency (EMA), through its Committee for Medicinal Products for Human Use (CHMP), gave its positive opinion for the marketing authorization of BIMERVAX®, the COVID-19 vaccine developed by HIPRA. It is a new generation vaccine designed 100% in the European Union, using recombinant protein technology.
With this agreement, Insud Pharma, through Exeltis and its local distributors, reinforces its position in the field of vaccines in Latinoamérica where it already had extensive experience thanks to its subsidiary company Sinergium in Argentina, specialised in the research, development, production and marketing of vaccines, as well as for its collaboration with different companies in the production and filling processes of the Covid-19 vaccine, at the beginning of the pandemic.
Salustiano Pérez, CEO of Exeltis, added that “this agreement ratifies the potential of our subsidiary as a global player and reinforces our position in a key therapeutic area such as vaccines. Leveraging Exeltis’ global network and expertise will be a huge benefit to citizens and health systems in all our countries.”
According to Carles Fàbrega, director of HIPRA’s Human Health Division, “Having a portfolio of vaccines of different technologies is a key aspect for the control of any pandemic. BIMERVAX® is based on a technology widely tested and known to be used in vaccines such as influenza, among others. Thus, people who are reluctant to be vaccinated with other vaccines now have an alternative, thus achieving higher rates of vaccination.
It is a bivalent adjuvanted vaccine containing a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2 and is indicated as a booster dose for people over 16 years of age. It is the first bivalent recombinant protein vaccine to be authorised in the European Union against the virus.
The EMA’s positive opinion comes after concluding that it has sufficient solid data on the quality, immunogenicity and safety of the vaccine. Phase IIb and III studies have shown that it is a safe, low-reactogenic vaccine with ample capacity to neutralise the main variants of concern of SARS-CoV-2, including the Omicron variants. Furthermore, in the comparative study versus mRNA vaccine as required by the EMA, 6 months after receiving the booster dose, people vaccinated with the HIPRA vaccine showed higher levels of neutralised antibodies compared to all variants studied, suggesting longer-lasting protection. In the same comparative study, it was shown to have less reactogenicity than mRNA vaccine.
BIMERVAX® is stored at a refrigerated temperature between 2ºC and 8ºC, facilitating storage and distribution. It is a “ready-to-use” vaccine, that is, it is not necessary to reconstitute it before its use, unlike others that do require it, thus facilitating the work of health personnel.
In addition, it is a vaccine that has been shown to be safe and with very low reactogenicity (side effects milder than mRNA vaccines). Due to its characteristics and the results demonstrated to date, it is a vaccine that fits very well with current needs considering the state of the pandemic.
About Insud Pharma
Insud Pharma is a leading Spanish company with more than 45 years of experience in the pharmaceutical and healthcare industry. With 7300 employees in more than 40 countries, Insud Pharma contributes to global public health through medicines and active ingredients that are developed and manufactured in its business areas: Industrial (Chemo), Brand (Exeltis), Biotechnology (mAbxience and Algenex) and Animal Health (Vetpharma).
Insud Pharma is part of the top 100 pharmaceutical companies in the world and is one of the groups with the greatest investment in R&D in Spain, so much so that it has received for the third consecutive year, the rating “EXCELLENT” in the Profarma Plan of the Spanish Ministry of Industry, Energy and Tourism.
The Spanish multinational, with headquarters in Madrid and present in more than fifty countries, has a strong presence in Europe and Latin America, where it is a leader through its division Exeltis in Women’s Health and Central Nervous System.
Exeltis is a fast-growing division of the integrated health sciences group, Insud Pharma. Exeltis has a global leadership position in the area of Women’s Health, where it continues to innovate and look for new treatments and devices. Also, in recent years it has diversified its portfolio to other areas such as Central Nervous System, Ophthalmology and Endocrinology. With a global presence spanning more than 40 countries, Exeltis has more than 4,000 professionals and a global manufacturing network.
HIPRA is a biotech pharmaceutical company focused on prevention for animal and human health, with a wide range of highly innovative vaccines and an advanced diagnostic service. With its claim “Building immunity for a healthier world”, HIPRA affirms its commitment to contribute to solutions that improve global health.
HIPRA has a strong international presence with 40 subsidiaries of its own (including Argentina, Brazil, Colombia, Mexico, Peru and Uruguay). 3 R&D centres and 6 production plants strategically located in Europe (Spain) and America (Brazil). In addition, its extensive international distribution network keeps marketing channels open with nearly 100 other countries, thus covering all 5 continents.
Research and development are at the core of their know-how. HIPRA dedicates 10% of its annual turnover to R&D activities that focus on the creation and application of the latest scientific advances for the development of innovative vaccines of the highest quality. To add value to its vaccination expertise, the company also develops medical devices and traceability services.
HIPRA performs and monitors all stages of production of its services and biological products in its state-of-the-art facilities. HIPRA is the company that has launched the most biotechnological vaccines in the last 10 years, with a total of 22 vaccines.