On November 13, 2014 Geron Corporation reported that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (“Janssen”) to develop and commercialize, imetelstat, Geron’s telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses (Press release Geron, NOV 13, 2014, View Source [SID:1234500961]). Imetelstat is a modified oligonucleotide that is currently 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). Under the terms of the agreement, Geron will receive an initial payment of $35 million due after the applicable waiting periods under the Hart-Scott Rodino Act 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. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.

“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 Chief Executive Officer.

Development of imetelstat will proceed under a mutually agreed clinical development plan, which is expected to include Phase 2 studies in MF and MDS as initial studies, additional registration studies in MF and MDS, and exploratory Phase 2 and potential follow-on Phase 3 studies in AML. Geron expects the initial Phase 2 study in MF to be initiated in mid-2015, followed later by a Phase 2 MDS study. Development costs for these two studies will be shared between the companies on a 50/50 basis.

Additional details regarding the collaboration can be found in Geron’s Form 8-K filed today with the Securities and Exchange Commission.