Geron, a Menlo Park, Calif.-based clinical stage biopharmaceutical company, has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech to develop and commercialize imetelstat, Geron`s telomerase inhibitor product candidate, for oncology, including hematologic malignancies and other human therapeutics uses.
Imetelstat is a modified oligonucleotide that currently is in early phase clinical development for myelofibrosis (MF) and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML). Geron will receive an initial payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales.
"By leveraging Janssen`s ability to fully integrate and strategically align global oncology development and commercialization, we expect this collaboration to expand the development of imetelstat across a range of hematologic malignancies and potentially increase the speed with which imetelstat can be made available to patients with these serious, life-threatening diseases," said Dr. John Scarlett, Geron`s president and CEO.
Development of imetelstat will proceed under a mutually agreed clinical development plan, which is expected to include phase II studies in MF and MDS as initial studies, additional registration studies in MF and MDS, and exploratory phase II and potential follow-on phase III studies in AML. Geron expects the initial phase II study in MF to be initiated in mid-2015, followed later by a phase II MDS study. Development costs for these two studies will be shared between the companies on a 50/50 basis.