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Year-end report 2012

Regulatory information

Financial information

  • Net sales for the Group amounted to SEK 2.6 (1.3) M
  • The Group’s net loss was SEK -16.5 (-24.6) M
  • Operating income for the Group amounted to SEK -16.8 (-24.5) M
  • Earnings per share were SEK -0.78 (-2.26)

The year in brief

  • Hansa Medical’s collaboration partner, Axis-Shield, launches CE-marked HBP assay
  • Patents granted in the USA and Europe for the medical use of IdeS
  • European patent granted for the diagnosis of severe sepsis with HBP
  • Clinical research results indicate that HBP is a good biomarker for the diagnosis of urinary tract infections.
  • Private placement to the venture capital company, NXT2B, followed by a subsequent preferential rights issue, contributing SEK 46 million to the company

Significant events after the end of the year

  • Hansa Medical receives approval from the Swedish Medical Products Agency to begin clinical Phase I study with IdeS

CEO’s comments

During 2012, we intensified our efforts preparing our biopharmaceutical candidate IdeS for a clinical phase I study. To commence clinical trials with a completely novel drug candidate requires extensive documentation and experimental support to be in place beforehand. Our rigorous preparatory work has proven to be worth our while, as the Swedish Medical Products Agency (SMPA) has granted us approval for our application to commence a clinical phase I study.

The approval is a major advancement for the IdeS project and for the company in general. We are both proud and pleased to have reached this stage in the project. The IdeS project holds the potential to effectively, and safely; help thousands of patients with kidney failure to get transplanted. These patients would otherwise be kept waiting more or less without hope for a suitable transplant. The Swedish Medical Products Agency’s approval of Hansa Medical’s proposed studies represents a large step forward for the IdeS project and this group of patients.

We will initiate the clinical phase I trial with healthy volunteers as soon as possible, and our goal is to complete the study during 2013. Primary objectives are to study tolerability and safety of IdeS, as well as its effect and pharmacokinetics. A Phase II study with transplantation patients is planned for 2014.

Parallel to our work with the IdeS project, our collaboration partner, Axis-Shield has launched a CE-marked HBP assay. The HBP-assay is possible to order through the HBP-product website www.heparinbindingprotein.com. As of now, emergency physicians, intensive care specialists and infectious disease specialists all over the world, can evaluate HBP as a biomarker for severe sepsis, for themselves. Broad credibility of the HBP-assay for diagnosis of severe sepsis will be generated through independent clinical studies. We anticipate the results from a clinical multicenter study with HBP to be published in 2013.

Emanuel Björne, CEO Hansa Medical AB (publ)