Hansa Biopharma and Medison Pharma announce marketing authorization in Israel for Idefirix® (imlifidase) for desensitization treatment of highly sensitized kidney transplant patients

• Israel is the first market outside of Europe to grant regulatory approval for Idefirix^®
• The decision by Israel’s regulatory authority provides highly sensitized patients in Israel with the opportunity to receive Idefirix^® as desensitization treatment
• The approval to use Idefirix^® as defined in indication approved by the European Medicines Agency (EMA)^1,2

Lund, Sweden and Petach Tikva, Israel March 28, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), the pioneer in enzyme technology for rare immunological conditions, and its partner Medison Pharma (“Medison”), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, today announce that the Israeli Ministry of Health has approved Idefirix^® for desensitization treatment of highly sensitized kidney transplant patients in Israel.

Idefirix^® is the first and only medicine licensed for desensitization of highly sensitized patients prior to kidney transplantation, allowing these patients to access a life-changing kidney transplantation from a deceased donor.

“The regulatory approval of Idefirix^® in Israel represents the first marketing authorization outside of Europe and is a milestone for our collaboration with Medison and more importantly for the highly sensitized patients we are dedicated to serving,” says Søren Tulstrup, President and CEO, Hansa Biopharma. “The approval in Israel further demonstrates our commitment to expanding the reach of Idefirix^® internationally to patients who are in need of this novel treatment.”

Highly sensitized kidney patients have previously had very limited access to kidney transplants due to the lack of effective desensitization treatments, and they often have no alternative but to remain on long-term dialysis. Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality, hospitalizations and additional costs.^3-5

“The approval of Idefirix^® in Israel is the result of both companies’ shared efforts to improve the lives of kidney transplant patients”, says Meir Jakobsohn, Founder and CEOof Medison Pharma. “This milestone is the first step in our joint commitment to provide access to this breakthrough therapy to patients across international markets.”