AiCuris-Team receives German Future Prize 2018

• Prof. Dr. Helga Rübsamen-Schaeff, Founding-CEO, and Dr. Holger Zimmermann, CEO of AiCuris Anti-Infective Cures GmbH, were awarded the German Future Prize 2018 (German President’s Award for Innovation in Science and Technology) presented by the German Federal President, Frank-Walter Steinmeier
• “Protection in the Absence of the Immune System - a Life-Saving Innovation against Dangerous Viruses” named as the winning project amongst 2018 nominees
• Together with their team, the two scientists developed the world’s first and only drug to prevent infections with a common virus in bone marrow transplant patients, generating a paradigm shift in this field of transplantation medicine

Wuppertal, Germany, November 29, 2018 - AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs targeting infectious diseases, is pleased to announce that Prof. Dr. rer. nat. Helga Rübsamen-Schaeff, founding-CEO, and Dr. rer. nat. Holger Zimmermann, CEO of AiCuris, have received the German Future Prize (Deutscher Zukunftspreis) 2018, one of the most prestigious prizes conferred for science and innovation within Germany.

The two scientists received the award for their groundbreaking research and development achievements in the field of anti-infective research. Their project “Protection in the Absence of the Immune System - a Life-Saving Innovation against Dangerous Viruses” was shortlisted as one of three outstanding German research and development projects by a jury of independent experts in science and industry. Prof. Dr. Rübsamen-Schaeff and Dr. Holger Zimmermann received the award yesterday evening presented by the German Federal President Frank-Walter Steinmeier as part of a festive awards ceremony.

Prof. Dr. Rübsamen-Schaeff and Dr. Holger Zimmermann together with their team were the first to identify and develop an active substance (Letermovir) that effectively protects patients with a weakened or ineffective immune system against human cytomegalovirus (CMV) infections. In a newly founded company, AiCuris, they further developed the drug, opening up new perspectives in transplantation medicine. In 2012, AiCuris licensed the drug to MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA), which became AiCuris’ commercialization partner. Today, the drug is approved and globally available to patients undergoing bone marrow transplantation and for whom a CMV infection poses a life-threatening risk.

“Being awarded with this prestigious prize is a great honor for us and one of the highlights in my scientific career,” said Prof. Dr. Helga Rübsamen-Schaeff, founding–CEO and today member of the Scientific Advisory Board of AiCuris Anti-infective Cures GmbH. “A decade ago, many pharmaceutical companies stepped away from anti-infective research leaving a growing gap between newly approved, innovative medicines and an ever-increasing medical need. We, on the contrary, decided to found AiCuris to serve this medical need in a globalized world and now are thrilled to see that our vision has paid off and that our product has made it to market as a new treatment that protects patients’ lives and substantially increases survival rates of bone marrow transplanted patients. The German Future Prize is an endorsement of the importance of our work and its impact on society - I would like to take this opportunity to thank the jury for recognizing our work and those who supported us on this journey. A very special thank goes to Dr. Andreas and Dr. Thomas Strüngmann. Their far-sighted investment in our newly founded company, their ongoing support and trust in our work and their financial backing have made the further development of Letermovir into a marketable product possible. For a young biopharma company, this is a very rare event and now allows to build the company further.”

The project: Protection in the Absence of the Immune System - a Life-Saving Innovation against Dangerous Viruses

For many patients with blood cancer, bone marrow transplantation is the last hope for a cure. In this process, the patient’s bone marrow, including cancer cells, are destroyed and replaced by stem cells from a donor. In order for the patient’s body to accept the foreign cells, the immune system must be “switched off” in preparation for the transplant. Due to the severe immune deficiency following transplantations, recipients of a stem cell graft, who carry a latent CMV infection have an extremely high risk of developing a CMV infection, which can lead to transplant failure and death.

The innovative drug developed by the AiCuris team offers for the first time the possibility of a prophylactic treatment against CMV infections. Its active substance Letermovir belongs to a new chemical class and thus uniquely differs from all substances previously used against CMV infections. The drug is therefore, not simply another development, but works via a completely new mechanism: It attacks a virus-specific structure, which does not naturally occur in the human body, and thus prevents the replication and therewith the spreading of the virus.

CMV is a common and widespread virus. Today, about 50% of the population in the developed world are CMV seropositive, meaning they have CMV antibodies in their blood, indicating a previous exposure to, or primary infection from CMV. In developing countries, that figure rises to 90-100% of the population. Individuals with an intact immune system rarely show symptoms after their initial infection, but the virus remains dormant in the body throughout their lifetime. In a weakened immune system, however, CMV can reactivate and lead to serious diseases in various organs, including damage to the gastrointestinal tract, pneumonia or eye infections (retinitis) that can cause blindness. While therapies against CMV are available, strong side effects make them unsuitable for protecting bone marrow recipients.

An innovative drug with great potential

For patients receiving bone marrow transplantations, Letermovir is the only approved treatment that is effective in preventing CMV infections, holding great potential to help patients as the number of bone marrow transplants worldwide is steadily increasing. It is estimated, that 40,000 of the 60,000 patients worldwide receiving bone marrow transplantations are at risk to develop a CMV infection. Additional patient groups could include: AIDS patients, newborns, recipients of other donor organs and patients in other conditions in which the immune system is weakened. Currently, a study is being conducted in kidney transplantation. To date, AiCuris has received upfront and milestones payments of 260 million Euro. In addition, AiCuris receives royalties on world-wide net sales. Analysts estimate world-wide peak sales to be in the high three-digit million Euro range. The company also has the option to co-promote the drug in some European countries.

“I am honored to be part of the team that has been chosen amongst many significant and important projects to receive this prestigious award”, said Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH. “For AiCuris, this project has been a breakthrough in many ways. Beside the medical achievement which is a validation of our scientific approach and ability to successfully discover and develop innovative therapies that have the potential to truly make a difference in the treatment of patients suffering from infectious diseases, it was also a financial success that truly takes the Company to the next level of development. With a total of 260 million Euro in upfront and milestone payments from MSD to date, we are now in a position where we have the necessary experience as well as the financial resources to driving future growth through investing in the further development of our pipeline of promising drug candidates and the Company’s infrastructure. I am excited about the next steps and am looking forward to the future with confidence in our growth prospects.”

About the winners

Prof. Dr. rer. nat. Helga Rübsamen-Schaeff
Prof. Rübsamen-Schaeff was CEO of AiCuris since its establishment in 2006 as a spin-out from the infectious disease unit of Bayer Healthcare, also previously led by her. In March 2015 she stepped down from the CEO position and has taken over the chair of AiCuris’ Scientific Advisory Board. Before her time at Bayer, she was the scientific and executive director of the Chemotherapeutical Research Institute Georg-Speyer-Haus in Frankfurt. A chemist by training, Prof Rübsamen-Schaeff was awarded the venia legendi from the University of Frankfurt and has been professor of biochemistry since 1988. Prof. Rübsamen-Schaeff has served on numerous committees, such as, the Senate of the Fraunhofer Society, the University Council of the University of Vienna and the jury for the Innovation Prize of the Federal President. Presently, she is a member of the board of partners of E. Merck KG and the chair of its research council, a member of the supervisory board of Merck KGaA, and a member of the scientific panel for health under the Horizon 2020 program of the EU. She also is a member of the National Academy of Science, Leopoldina.

Dr. rer. nat. Holger Zimmermann
Dr. Holger Zimmermann took over responsibilities as CEO of AiCuris in 2015 after two years as the Company’s managing director and deputy CEO. Prior to this he served for six years as Chief Scientific Officer (CSO) of AiCuris. He was part of the spin-out which formed AiCuris in 2006. Dr. Zimmermann was originally head of virology and project leader for the HCMV-portfolio (out-licensed to MSD in 2012). Prior to AiCuris Dr. Zimmermann worked at Bayer Health Care as the laboratory head and project leader for virology. He obtained his PhD in Biology in Cologne and worked for seven years in a variety of academic institutions, including three years at the Institute of Molecular and Cell Biology (IMCB) of the National University of Singapore. Dr. Zimmermann is author/co-author of numerous scientific publications and has been named inventor in more than 25 patent applications. He is member of national and international scientific societies and serves on several boards including the International Society on Antiviral Research and the German Society of Virology (GfV) on Antiviral Therapy. Dr. Zimmermann is also a member of the executive board of BioDeutschland.

About German Future Prize (Deutscher Zukunftspreis)

The German Future Prize has been awarded annually since 1997 and recognizes projects, which, based on excellent research, lead to marketable products that are ready for application and create jobs. Endowed with 250,000 Euro, the award honors scientific innovations and ideas that gave rise to commercial success with the potential to impact lives, making them easier, improve them, and sometimes even save them.

It is a sign of recognition for achievements and an investment in the creativity, courage and perseverance of researchers – qualities that are indispensable when it comes to conquering new scientific territory also in the future and finding answers to the pressing questions of today and tomorrow.

For more information on the German Future Prize, please visit: https://www.deutscher-zukunftspreis.de/en/.

About Letermovir

Letermovir is a member of a new class of non-nucleoside CMV inhibitors (3,4 dihydro-quinazolines) and inhibits viral replication by specifically targeting the viral terminase complex. Cross-resistance is not likely with drugs outside of this class. The drug is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors and it has no activity against other viruses. Letermovir has been granted orphan designation for the prevention of CMV disease in at-risk populations in the USA, Europe and Japan.

Under an agreement signed in 2012, MSD (through a subsidiary) purchased worldwide rights to develop and commercialize Letermovir (PREVYMIS™) from AiCuris GmbH & Co KG (www.aicuris.com). The drug is approved for use in bone marrow transplants in the EU, Switzerland, the USA, Canada and Japan.

About AiCuris Anti-infective Cures GmbH

AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs targeting infectious diseases. SANTO Holding is the Company’s majority investor. PREVYMIS™ (Letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor acting via a novel mechanism of action that was licensed to MSD in 2012, is approved for use in bone marrow transplants in the EU, Switzerland, the USA, Canada and Japan. for prevention of CMV infections in adult recipients of an allogeneic hematopoietic stem cell transplant. The Company develops drugs for the treatment of viruses such as human CMV, herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses. In the field of antibacterials, AiCuris seeks to develop innovative treatment options for life-threatening, (multidrug)-resistant hospital-treated pathogens.

For more information, please visit www.aicuris.com.

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