CEO Statement

 

We are very grateful for the time we had Göran at the helm of Hansa Medical. Through his inspiring and genuine commitment, he has built a strong growing biopharmaceutical company with clear and ambitious strategic plans and a dedicated organization capable of executing and delivering on milestone targets. Göran will be greatly missed by all of us, as a true professional and as a warm and inspiring person. We are  firmly dedicated to continue the development of our company in the direction outlined by Göran and the board of directors. Göran’s work in collaboration with the team in Lund and in the US, has taken us to a very strong position in the development of innovative immunomodulatory enzymes.

During the third quarter, we received further evidence that IdeS has great potential as a new and innovative treatment to enable life-saving kidney transplantation. In our ongoing clinical Phase II studies with IdeS a total of 42 patients have been transplanted, which reinforces our view that IdeS could represent an entirely new approach for eliminating HLA antibodies to enable transplantation for highly sensitized patients.

In line with the clinical progress, we have also gained increased attention from in the medical research community and among other stakeholders. In August, data was published from three independent clinical Phase II studies with IdeS in the high impact medical journal The New England Journal of Medicine. The article, titled “IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation”, concludes that treatment with IdeS effectively reduces donor-specific antibodies (DSAs) to levels that enable life-saving transplantation for highly sensitized kidney transplant patients. This is a very important milestone for highly sensitized patients awaiting a kidney transplant and for us as a company.

In October, we hosted Capital Markets Days in Stockholm and in London, where we shared these important study results with our shareholders and provided details of our strategy for the company’s next phase of development. During the events, senior management from Hansa Medical and leading transplant experts gave an update on our projects and the latest research  findings. The interest from both our shareholders and the research community, further sup- ports the relevance and medical importance of our research and development of immunomodulatory enzymes.

This year, in parallel with our innovative work in organ transplantation, we have taken the  first important clinical steps to broaden the use of IdeS. We believe there is significant therapeutic potential for the fast and efficient IgG cleaving mechanism of action of IdeS in both serious transplant-related indications and acute autoimmune diseases, such as anti-GBM antibody disease.

As of today (November 14, 2017)  five patients have been treated with IdeS in an ongoing investigator-initiated Phase II study in severe anti-GBM antibody disease, a rare and acute autoimmune disease in which the kidneys often are irreversibly damaged resulting in the need for dialysis treatment or kidney transplantation. Limited follow-up data is currently available from three of these  five patients, who have responded favorably. IdeS appears to be well tolerated so far in these patients. In addition, prior to initiation of this clinical study, three patients with anti-GBM antibody disease were treated on a named patient basis in Sweden. Hence, a total of eight patients with anti-GBM disease have been treated with IdeS as of November 14, 2017.

In total, approximately 15 patients will be recruited to the anti-GBM study at up to 15 clinics in Europe. This may provide evidence that IdeS has the potential to be an important treatment in additional serious, acute IgG-mediated diseases for which no approved treatments exist today.

During this year, we have continued to build a strong and committed team expanding broadly in both R&D and marketing as well as in the medical department to which we recently hired two seasoned senior medical science liaisons in the US, to support our increasing presence in this important market for future anticipated launches. We have increased the number of co-workers significantly and are now around 40.

We have made significant investments in the IdeS production pro- cess during 2017 and we continue to prepare product supply for commercialization of IdeS. The processes have been transferred to manufacturers in Europe suitable for commercialization and the product we are preparing for launch is going to be a lyophilized product for easy off the shelf use and for convenient and effective world-wide distribution.

Naturally, we still have several milestones to achieve until we have a product on the market, but the overall progress in recent months is very encouraging and has further strengthened our belief in the future of IdeS. Our position to become a pharmaceutical company with important, life-saving products on the market is becoming more prominent for every milestone we reach and I look forward to updating you on our continued development.

Ulf Wiinberg
Acting CEO
September 30, 2017