Year-End Release 2010
• Net sales for the Group amounted to SEK 4.4 M (3.0)
• The Group reported a loss of SEK 18.8 M (loss: 15.8)
• The Group’s operating loss amounted to SEK 20.0 M (loss: 15.7)
• The loss per share was SEK 2.44 (loss: 4.1)
The year in brief
• Rights issue totalling SEK 27 M oversubscribed
• Full-scale production process for IdeS developed
• Toxicology and safety studies initiated with IdeS
• Patent granted for IdeS in the USA
• Research studies with IdeS and EndoS published in scientific journals
• License agreement entered with Human Genome Sciences Inc., regarding anti-alpha-11 patents
• Milestone payment of USD 500,000 received from collaboration partner Alere Inc.
• Anti-alpha-11 antibodies generated through collaboration with Alere Inc.
• Optimised version of HBP assay developed in collaboration with Axis-Shield plc for pivotal clinical study
Significant events after the end of the financial year
• Hansa Medical’s collaboration partner Axis-Shield plc entered into an option agreement with Bio-Rad Laboratories for the commercialization of HBP
An oversubscribed rights issue has enabled an offensive investment in project IdeS and has allowed us to retain the pace of development in project anti-alpha-11 and HMD-301. In cooperation with a contract manufacturing organization, we have brought our internally-developed production process to full scale for the fermentation, purification and quality control of the drug candidate, IdeS. The upscaling work has developed positively and we have now produced a first batch of IdeS with high yield and high purity. This batch will be primarily be used for pre-clinical toxicity and safety studies. These studies have been initiated and we plan to have them completed during the spring of 2011. If the outcome of these studies is positive, we will initiate Phase I at the end of 2011 or at the beginning of 2012.
Within project anti-alpha-11, a number of promising antibodies have been identified and the patent portfolio has been consolidated. We have entered a license agreement with Human Genome Sciences Inc. regarding anti-alpha-11 antibodies, and a strong patent position for the anti-alpha-11 program and upcoming pharmaceutical products, has been established.
Our collaboration with Axis-Shield plc has developed successfully. Using Hansa Medical’s prototype assay (HMD-301) for quantifying HBP in plasma, Axis-Shield has developed an optimized version. The registration based trials with this optimized assay will commence at the beginning of 2011. In January 2011, Axis-Shield entered an option agreement with Bio-Rad Laboratories regarding HBP as bio-marker for severe sepsis. This option agreement confirms the potential of this exciting product candidate, as well as strengthening the possibilities of reaching the global market.
These are exciting times for Hansa Medical. During the next 12 months, our plan is to initiate introductory clinical studies with IdeS, to achieve the registration of HMD-301 and to identify an anti-alpha-11 drug candidate suitable for clinical development. Emanuel Björne, CEO of Hansa Medical (publ).