Scandinavian Biopharma is pleased to announce another year of significant growth. For the full year 2023, the revenue increased by over 33 MSEK, corresponding an organic growth of 27%. The total revenue for 2023 amounted to 154 MSEK.
It is with great pleasure that we present another really good year of growth. The figures for the full year 2022 add up to an increase in sales equivalent to 30% in organic growth. In total, sales amount to approximately SEK 122 million. Our ETEC vaccine candidate, ETVAX, is about to enter phase 3.
In 2020, Scandinavian Biopharma entered into an agreement with USAMMDA to fund manufacturing and development activities for its ETEC diarrhoea vaccine, ETVAX®. The agreement has now been extended, providing additional financial support. The objective is to accelerate the development and approval of the vaccine in the United States.
2021 was another successful year for Scandinavian Biopharma. The company took important steps in the development of the ETEC vaccine candidate and the distribution business set a new sales record by reaching SEK 93.8 million. The company continued to grow organizationally and expanded the team in both production, QC and QA, this expansion in turn required the business to expand its office space.
We are expanding the business so much that we need larger premises. During the pandemic, the company has hired many new employees in research, clinical development, registration, manufacturing and sales. The space is specially adapted for Scandinavian Biopharma's operations and has a tailor-made, state of the art laboratory with a process development unit as well as a modern meeting place.
An improved user-friendly formulation of the world's most advanced ETEC vaccine candidate, ETVAX®, has been developed to meet commercial requirements. We want to ensure that the new formulation gives rise to immune responses that are non-inferior (i.e. not worse) to the previous formulation of the vaccine that underwent earlier testing. This is done in a phase II double-blinded, randomized study.
The Vaccines Against Shigella and ETEC (VASE) Conference, on September 28 & 30, will provide key updates on vaccines being developed for Shigella, ETEC, and other emerging diarrheal pathogens. 2 of the 18 presentations at VASE is highlighting our ETEC vaccine candidate ETVAX®.
Welcome Fernanda, to our team at Scandinavian Biopharma.
We are pleased to welcome Günes Uysal to our team at Scandinavian Biopharma.
The year we have left behind us has been different in many ways. Despite the major impact the pandemic had on operations in 2020, Scandinavian Biopharma reports largely unchanged revenue for the distribution operations and important progress has been made in the development of the ETEC vaccine candidate ETVAX®.
The documentary, People We Come Across follows Scandinavian Biopharma’s vaccine study in Benin where more than 700 Finnish tourists travelled on a holiday as research volunteers. The documentary describes the interactions between the inhabitants of the fishing village of Grand Popo and the Finnish participants.
We are proud to announce that all participants have now received the third and final vaccination dose in our Phase 1 trial in Zambia. The completion of the enrolment in the Zambian study is another important milestone towards making a vaccine available for children in low- and middle-income countries. An ETEC-vaccine is prioritized by WHO.
Encouraging results from a Phase 2b study. The trial enrolled adult volunteers from Finland who travelled to Benin after receiving ETVAX® or placebo. The study results confirm the excellent safety and overall positive immunogenicity of ETVAX®, as well as a significant protective efficacy of 56% against all severe diarrhea, independent of pathogen.
We are proud to announce that the first cohort of 40 adults was enrolled in our Phase I study in Zambia. The study is part of a late phase development program in Africa funded by EDCTP with 7,4 million Euro. The program consists of two clinical trials and is initiated with a Phase I trial in Zambia to evaluate the optimal dose of ETVAX® and the benefits of a booster dose in young children.
We have refreshed our brand identity for it to better align with our business model, core values and vision. The whole team has been engaged in the rebranding process and together we have formed the basis of Scandinavian Biopharma’s new graphical design that is being launched today.
Scandinavian Biopharma will present at the Nordic Life Science Days event 2019. The conference will take place on 10-12 September in Malmö, Sweden. The presentation will be held in Room C at 15:30pm on September 11th and we would like to invite you to listen to an update on progress of the most advanced diarrhoeal vaccine against ETEC and our commercial strategy forward.
Scandinavian Biopharma can look back on a very successful 2018! The company was granted 7,4 MEUR from EDCTP for testing the protective efficacy of the ETEC vaccine candidate ETVAX® in children below five years of age in Low- and Middle-Income Countries. The distribution business achieved a very strong organic sales growth of 58%.
Scandinavian Biopharma continues to expand and has now recruited Dilek Merdol as new head of QC. Dilek has a PhD in infectious biology and has 20 years’ experience in R&D and laboratory operations. She comes from a position as manager in the unit of Clinical Microbiology at Karolinska University Laboratory.
“I am looking forward to the challenges and opportunities that this fast-growing co
In record time we completed a phase IIB randomized, double-blind, placebo-controlled trial in Finnish travellers going to West Africa. In total 743 travellers spent a fortnight in Benin. Half of the group were given the ETEC vaccine candidate, ETVAX®, and the other half placebo. The aim of the study was to evaluate safety and estimate the protective efficacy in a naive population.
This trial will establish the exact safe and immunogenic dose of the vaccine in young children (6-23 months of age) as well as to explore the potential benefits of a third booster dose. The study will be initiated in healthy adults and followed by young children (6-23 months of age) in Zambia starting from May 2019.