April– June 2018 briefly
” Lasting follow-up data from the 17 people treated with imlifidase in the investigator-initiated Phase II research study in extremely sensitized patients existed at the 2018 American Transplant Congress in early June by Teacher Stanley C. Jordan, M.D., Director of Nephrology, Cedars-Sinai Medical Facility.
- ” Clients show good renal feature as well as marginal evidence of antibody-mediated being rejected (AMR) at a mean 19 months article kidney transplantation, with graft as well as person survival at 94%.
- ” Two-year follow-up data show excellent client and also graft survival without boosted infection danger which no major unfavorable events related to imlifidase have been reported in the study.
- ” The board of directors strengthened its know-how in biopharma commercialization and R&D through the visits of Anders Gersel Pedersen and also Andreas Eggert.
” Anders Gersel Pedersen, MD, Ph.D, currently serves as Executive Vice Head Of State, Research Study & Growth at H. Lundbeck A/S and is a member of the boards of Genmab A/S and Bavarian Nordic A/S.
” Andreas Eggert, MBA has more than two decades of crossfunctional leadership experience in biopharma commercialization, consisting of Senior citizen Group Vice President, Global Item Strategy & Profile Advancement at H. Lundbeck A/S as well as Vice Head Of State & Global Manager at Wyeth/Pfizer in the United States.
” Hansa Medical created the United States subsidiary Hansa Medical Inc. for the continued build-up people organization as well as visibility.
Significant occasions after the end of the reporting period
” The United State Fda (FDA) approved orphan medicine designation to imlifidase for the treatment of the unusual and alsointense kidney illness anti-GBM antibody illness, likewise called Goodpastures disease.
” Orphan medicine classification qualifies the enroller of the medication for various advancement incentives, consisting of tax obligation credit ratings, method assistance as well as approximately 7 years of US marketing exclusivity from time of approval of Biologics Certificate Application (BLA).
” The authorization confirms the high unmet medical requirement and also additional motivates proceeded scientific examinations with imlifidase in this ruining condition in which less than one third (5) of the people endure with a managed kidney feature after 6 months follow-up.
- Hellmark et al., Journal of Autoimmunity 48-49 (2014) 108e112. “Diagnosis and also category of Goodpasture’s disease (anti-GBM)”.
Financial recap for the Team.
KSEK, unless or else stated.
- Net revenue.
- Running profit/loss.
Revenues per share prior to and after dilution (SEK).
Capital from operating activities.
Cash and also money matchings consisting of short term investments.
Chief executive officer statement.
It has actually been an enjoyment to join Hansa Medical. I am impressed by what has actually been achieved to date, and the extra I find out, the more I see exactly how highly placed we are to bring a special treatment to market and build a global biopharma venture. This impression has not just been gained via communications with our teams in Sweden and the United States, yet also with my conferences with crucial point of view leaders and also with health care expert financiers throughout the United States and Europe.
Detailed we have remained to proceed our method and also I feel confident that we will be able to launch a lifesaving product. Considering that I joined Hansa Medical in March, we have continued to increase the company in order to develop our capabilities to release imlifidase (formerly called IdeS) on our very own. We have actually also remained to grow the R&D group in order to initiate and also finish extra scientific studies in antibody-mediated kidney transplant rejection (kidney AMR) as well as the damaging acute neurological condition Guillain-Barré disorder.
The growth of imlifidase remains to proceed according to plan. To day, we have actually efficiently made and also handled a series of scientific research studies, showing its capacity to allow lifesaving kidney transplantation in very animated patients, a sign where there is substantial unmet medical requirement.
Earlier this year, we completed person registration in the two ongoing Phase II studies with imlifidase in very sensitized kidney transplant people. An overall of 18 individuals were enrolled in the worldwide multicenter research Highdes, and 17 individuals were registered in the United States investigator-initiated study at Cedars-Sinai Medical Center, led by principal investigator Teacher Stanley Jordan.
The goal, to allow kidney hair transplant for highly sensitized clients with donor-specific antibodies, was achieved in all 35 people in both studies. The individuals’ cross-match tests for contributor specific antibodies have actually all been moved from positive to unfavorable complying with the therapy with imlifidase. At the 2018 American Transplant Congress in very early June, Teacher Jordan offered follow-up information from the 17 patients dealt with in the Cedars-Sinai research. The arise from the study show that clients show good kidney feature as well as very little proof of antibody-mediated rejection (AMR) at a mean 19 months article kidney hair transplant, with graft and also client survival at 94 percent. Additionally, Professor Jordan highlighted that the two-year follow-up information show great patient as well as graft survival, without any proof of raised infection danger. Furthermore, no significant unfavorable events pertaining to imlifidase were reported in his research study.
These outcomes are extremely encouraging. The clients treated in the Cedars-Sinai study showed substantial sensitization with a mean computed Panel Reactive Antibody (cPRA- a step of sensitization for transplant prospects) rating of 95 percent and also we have taken care of to allow hair transplant for individuals who have gotten on dialysis for more than two decades.
We remain to follow the 18 people who have actually been treated with imlifidase as well as ultimately transplanted in the Highdes research. All cured individuals are to be kept track of for 6 months to collect follow-up information with respect to security, kidney feature and also monitoring of being rejected episodes. We expect to have access to six-month follow up data from the 18 clients in the Highdes study and the 17 individuals in the Cedars Sinai study, by the end of the 3rd quarter this year. This is going to be a very essential milestone for us as well as the continued development program with imlifidase.
Ahead of this, we are preparing conferences with both the US Fda (FDA) and also the European Medicines Agency (EMA) to go over a potential route towards filing of a Biologics Permit Application (BLA) in the US and the declaring of an Market Permission Application (MAA) in Europe at the end of 2018 or very early 2019. Along with the six-month follow-up data, essential products for these conversations will certainly be the favorable data demonstrating the effectiveness and also safety of imlifidase to allow kidney transplantations, the validation of the production procedure for imlifidase, and also most importantly, the substantial medical demand for these extremely sensitized patients who today have really minimal chances, if any, to be transplanted.
We are figured out to bring imlifidase to market in kidney transplant asap. Our long-term vision is to bring imlifidase to a variety of clients experiencing acute IgG-mediated illness. To us as well as several essential viewpoint leaders, it is fairly apparent that imlifidase has the possible to considerably add to the vital treatment in acute autoimmune diseases as well as numerous added transplant-related indicators. Today, a lot of these conditions are acutely treated with plasma exchange or immunoglobulin therapy in order to get rid of or regulate pathogenic IgG, which can be prolonged and inefficient procedures. We believe imlifidase can possibly get rid of pathogenic IgG dramatically quicker and more effectively in these intense diseases.
Consequently, we remain to increase our involvement in the examination of imlifidase in these problems. Currently, a Phase II research is recurring in the intense kidney disease severe anti-GBM, a disease in which two-thirds  of the individuals lose their kidneys, calling for chronic dialysis as well as the need for kidney transplantation. This research is recurring in Denmark, Sweden as well as Austria and also quickly centers in France, UK and the Czech Republic will sign up with the research study. Around 15 individuals are to be enlisted and to date 7 individuals have been treated as well as reacted positively with an excellent safety and security account. In very early July, the FDA authorized our application for orphan medication classification for imlifidase and also the therapy of anti-GBM (Goodpastures disease). The approval verifies the high unmet clinical requirement and more motivates us to proceed clinical examinations with imlifidase in this ravaging illness.
Additionally, we are preparing the initiation of two even more Stage II researches in the fall. The first research to be launched is likely to be therapy of antibody-mediated kidney transplant denial. We are targeting at signing up 15-25 people to this study in the US and in Europe. The 2nd research study will be a Stage II research in the intense neurological condition Guillain-Barré syndrome (GBS), to which we intend to enroll around 30 individuals, mainly in Europe.
With an expanding body of scientific evidence, different possibilities to broaden using imlifidase to a wide variety of indications, as well as a variety of next-generation medicine candidates in growth, I believe we are well-positioned to come to be an international biopharmaceutical business offering special, proprietary as well as life-saving IgG-eliminating medications to patients throughout a range of problems where IgG plays a vital duty in condition development or develops a barrier for patients to obtain appropriate therapy. I anticipate updating you on our ongoing progression.