Dear Shareholder, 2017 was another successful year for Genmab during which the determined Genmab team continued to work effectively towards our vision of transforming cancer treatment. We saw great progress with DARZALEX, tisotumab vedotin and with our early stage product pipeline, and exceeded our financial goals.
DARZALEX reaches new heights
DARZALEX continued its success in 2017. Three new approvals came during the year - in Europe, the U.S., and Japan. We reported another strong set of clinical data for daratumumab - the ALCYONE study treating newly diagnosed multiple myeloma patients, for which regulatory applications were submitted in the U.S. and Europe in November. And many new studies - including a number of pivotal trials - were started during the year so that there are now over 50 daratumumab studies running.
DARZALEX became a blockbuster drug, reaching over USD 1 billion in sales in 2017. It was the first year where the drug had a broader label both in the EU and the U.S. Our collaboration partner, Janssen Biotech, has done a fabulous job commercializing this ground-breaking medicine, making DARZALEX the best multiple myeloma drug launch in history and one of the top five most successful launches in cancer. Most importantly, that means more patients with multiple myeloma are getting help.
In 2018, we expect to see additional progress for DARZALEX, including potential new label expansions, early clinical data in solid tumors and topline data from the MAIA and CASSIOPEIA Phase III studies treating patients with newly diagnosed multiple myeloma.
Expanded proprietary pipeline
Last year we reported promising cervical cancer data from the Phase I/II study of tisotumab vedotin. Based on the data we are starting a potentially registrational Phase II study for patients with advanced cervical cancer. Excitingly, this study will be conducted together with Seattle Genetics following their decision to opt in to co-develop and co-commercialize tisotumab vedotin with Genmab this past August. We plan to further expand development of tisotumab vedotin with two Phase II studies in cervical cancer this year, as well as a new study in different solid tumors. The HuMax-AXL-ADC Phase I/II study in solid tumors remains ongoing and we expect to start the expansion phase in the study this year.
In 2017, we doubled our proprietary clinical product pipeline with the submission of investigational new drug applications (INDs) for the HexaBody-DR5/DR5 and DuoBody-CD3xCD20 programs. These are innovative antibodies that have the potential to treat different types of solid tumors and hematological cancers. Phase I studies are planned to start this year. These are the first Genmab proprietary antibodies developed with the DuoBody and HexaBody technologies to enter the clinic and we are excited to complete the step from invention to clinical product.
Building a strong Genmab
We are a team of knowledgeable, focused, determined and passionate individuals all working towards the same goal of improving lives for cancer patients. Our growing revenue from DARZALEX royalties allows us to continue to invest in our innovative product pipeline and we are now also building our commercialization and launch capabilities. As we work towards our 2025 vision, we will continue to grow and build the company to add the skills and competencies necessary so we can market our own product in the future.
2018 promises to be another energizing year at Genmab during which we will continue to strive to fundamentally transform cancer treatment and create value for patients and shareholders. I would like to take this opportunity to thank all our shareholders for your continued support.
Jan van de Winkel, Ph.D. President & Chief Executive Officer