January–December 2017 Business Highlights
Publication of clinical data in The New England Journal of Medicine
Combined data from three independent clinical Phase II studies with Hansa Medical’s lead candidate IdeS was published in The New England Journal of Medicine 2017;377:442-53, August 3, 2017 issue. The published results demonstrate that treatment with IdeS is effective in reducing donor-specific antibodies (DSAs) to levels allowing lifesaving kidney transplantation of highly sensitized patients.
Raised SEK 545 million and broadened the investor base
Hansa Medical successfully raised SEK 545 million (USD 65 million), gross, through a directed share issue to a number of US, UK and Swedish specialist healthcare investors. The proceeds will enable the timely completion of ongoing clinical studies with IdeS evaluating the efficacy of this drug candidate to enable kidney transplantation in highly sensitized patients. The proceeds are also being used to expand the company’s commercial and medical affairs’ capabilities. Hansa Medical will also carry out several clinical studies in related transplant indications and in selected acute autoimmune diseases.
Access to PRIME granted by EMA
The European Medicines Agency (EMA) granted Hansa Medical access to its Priority Medicines (PRIME) scheme for IdeS in enabling kidney transplantation for highly sensitized patients. PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need.
Continued patient enrollment in Phase II study with IdeS in anti-GBM
Continued patient enrollment in the investigator-initiated Phase II study with IdeS in anti-GBM. The study began in June 2017, and as of March 21, seven patients have been recruited and treated with IdeS. Limited follow-up data is currently available from five of these seven patients who have all responded favorably and IdeS appears to be well tolerated. Patients enrolled in the study will be monitored for six months.
Ulf Wiinberg served as Acting CEO November 9, 2017 to March 20, 2018
Ulf Wiinberg, the company’s Non-Executive chairman, was appointed Acting CEO, following the tragic and unexpected death of the company’s CEO, Göran Arvidson. Board member Birgit Stattin Norinder was appointed chairman.
Significant events after the end of the reporting period
Søren Tulstrup appointed new President and CEO
Søren Tulstrup appointed new President and CEO of Hansa Medical effective March 20, 2018. Hansa Medical’s acting CEO Ulf Wiinberg reverts to his former role as Chairman of Hansa Medical and Birgit Stattin Norinder reverts to her former role as member of the board of directors. Søren Tulstrup has a broad and extensive background as senior executive in the global biopharma industry. Recently, he served as CEO of Vifor Pharma AG (VTX:VIFN), a Swiss-based global pharmaceutical company with a market-leading position within chronic kidney disease, annual sales of approximately USD 1 billion and 2,000 employees.
Completed enrollment in Highdes study
Completed enrollment in Hansa Medical’s international multicenter Phase II study Highdes. The primary objective of the study – to turn a positive crossmatch test into a negative and thereby enable kidney transplantation - was accomplished in all 18 treated patients. All patients will be monitored for six months.
Finalized enrollment in US investigator-initiated Phase II study
Finalized enrollment in US investigator-initiated Phase II study with IdeS in highly sensitized patients. IdeS effectively reduced the level of DSAs in all 17 treated patients and turned the crossmatch tests from positive to negative, thereby enabling transplantation for all patients. All patients will be followed for six months to monitor safety, kidney function and DSA levels.
US orphan drug designation for IdeS in Guillain-Barré syndrome
The FDA granted orphan drug designation to IdeS (INN: imlifidase) for the treatment of Guillain-Barrés syndrome. The FDA Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease that affect fewer than 200,000 people in the US. Orphan drug designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits, protocol assistance and up to seven years of orphan drug exclusivity.