Date: 2014-11-13
Type of information: Licensing agreement
Compound: imetelstat
Company: Janssen Biotech, a J&J company (USA - NJ) - Geron (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: development licensing collaboration commercialisation
Action mechanism: Imetelstat is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary data suggest disease-modifying activity by imetelstat is by affecting the malignant clone associated with hematologic malignancies.
Disease: myelofibrosis, myelodysplastic syndrome, acute myelogenous leukemia, hematologic myeloid malignancies
Details: * On November 13, 2014, Geron announced that the 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 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). 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.
Financial terms: 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.
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