CEO Statement

 

 

2017 was a successful year for Hansa Medical, during which we reached several important milestones in our clinical studies and broadened our long-term investor base to include specialist international healthcare funds. We also gained increased attention from the medical research community following the publication of IdeS clinical data in The New England Journal of Medicine.

A lot of the progress achieved during the year should be attributed to the groundwork of our late CEO Göran Arvidson, who unexpectedly passed away in November. Through his inspirational leadership and dedication, he evolved Hansa Medical into a strong, emerging biopharmaceutical company with a clear, ambitious strategy and a dedicated organization capable of executing and delivering on milestone targets. We are firmly dedicated to continuing the development in the direction outlined by Göran and the board of directors. We are currently recruiting a new CEO for Hansa Medical.

During the year, we received further evidence of the potential of our lead compound IdeS as a new and innovative treatment to enable life-saving kidney transplantation. Our two ongoing clinical Phase II studies in Europe and the US completed enrollment in January 2018, and a total of 35 patients were treated with IdeS prior to kidney transplantation. IdeS effectively reduced the level of donor-specific antibodies (DSAs) in all patients and turned the cross-match tests from positive to negative, thereby enabling transplantation for all patients. Safety, kidney function and DSA levels will be monitored for all patients during a six-month follow-up period in 2018.

We received further validation of the increasing medical need for IdeS as a new treatment option to enable kidney transplantation in highly sensitized patients, when the European Medicines Agency (EMA) granted our IdeS development program access to its Priority Medicines (PRIME) scheme. This allows us to continue to accelerate the development of IdeS. Access to the PRIME scheme was granted on the basis of data from both our finalized and ongoing Phase II studies in sensitized patients.

In line with the clinical progress, we also gained increased attention from the medical research community. In August, data from three of our clinical Phase II studies with IdeS was published in one of the leading medical journals, The New England Journal of Medicine. The article, titled IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation, concluded that treatment with IdeS effectively reduces DSA and thus enables lifesaving transplantation for highly sensitized kidney transplant patients. The publication is an important peer review of our novel treatment concept and now also forms the basis for interactions with global key opinion leaders, both in transplantation and within several autoimmune indications.

In parallel with our work in organ transplantation, we have taken the first important clinical steps to broaden the use of IdeS for both transplant-related indications and acute autoimmune diseases. A phase II study is ongoing in anti-GBM antibody disease, a rare and acute autoimmune kidney disease, where approximately 2/3 of the patients lose their kidney function, resulting in the need of chronic dialysis. We are also planning a Phase II study in Guillain-Barré syndrome (GBS), a rare acute autoimmune neurological disease.

In the third quarter, we announced that five patients had been included in the investigator-initiated Phase II study in severe anti-GBM. Limited follow-up data is currently available from three of these five patients who have all responded favourably. IdeS appears to be well tolerated. The study aims to enroll approximately 15 patients at clinics/centers across Europe. Also, prior to site initiation of this study, three additional patients were treated on a so called named patient basis in Sweden.

GBS is another promising indication in which IdeS’ mode of action has the potential to make significant treatment improvements. Early in 2017, preclinical in vivo data with IdeS was published in the scientific journal Experimental Neurology, demonstrating that treatment with IdeS could be a promising new therapeutic strategy for GBS. A clinical Phase II study in GBS is currently under design.

We made significant investments in the IdeS manufacturing process during 2017. The processes have been transferred to manufacturers in Europe suitable for commercialization. The IdeS product intended for launch is lyophilized for convenient and effective world-wide distribution.

We are in a strong and unique position in the development of our novel immunomodulatory enzymes. Our vision is to become a world-leading IgG-modulating company and bring our products to patients across a range of conditions where IgG plays a key role in disease progression or forms a barrier for patients to receive appropriate treatment.

With this vision in mind, in November, the Board resolved the company to undertake a directed share issue that raised SEK 545 million. The proceeds from this offering are being used to fund the continued development of our existing product portfolio and to expand our medical affairs and commercial capabilities, ahead of a potential US and European approval and subsequent launch of IdeS. We received strong interest from several reputable US, UK and Swedish institutional investors and the share issue was fully completed by December 29, 2017.

During 2017, we continued to build a strong and experienced team expanding our capabilities in R&D, medical affairs and marketing, and we now have a dedicated team of approximately 40 co-workers. We will continue to add more expertise to the organization, particularly within regulatory affairs, medical affairs and commercial competencies.

Looking ahead, we will continue to build on the progress we have made in recent years. The successful financing event enables us to continue implementing our strategy. Our focus will be on completing the development of IdeS in highly sensitized patients and the ongoing Phase II study in anti-GBM as well as initiating additional Phase II studies in closely related transplant indications and in Guillain-Barré syndrome. In addition, we will continue the development of our novel IgG-eliminating enzymes, as well as explore development of potential applications in oncology of these enzymes.

We still have a number of milestones to reach before IdeS is potentially available on the market. During 2018 we plan to continue discussions regarding the regulatory path to approval for IdeS in transplantation with both the FDA and EMA. In addition to the convincing data demonstrating the efficacy and safety of IdeS in enabling kidney transplantation, important items for these discussions will be six-month follow-up data, further improvements of the manufacturing process, and the significant medical need for these highly sensitized patients who today have very limited chances, if any, to be transplanted.

We have made progress in our strategy, the foundations are now in place and we are on track to achieve our vision of becoming a world-leading IgG-modulating company delivering important, life-saving products to patients across a range of conditions where IgG plays a key role in disease progression or forms a barrier for patients to receive appropriate treatment. I look forward to updating you on our continued progress.

Ulf Wiinberg
Acting CEO of Hansa Medical
Lund, Sweden
February 14, 2018