Geron Announces $935-Million Global Strategic Collaboration With Janssen
Geron Corporation recently announced it has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize, imetelstat, Geron’s telomerase inhibitor product candidate for oncology, including hematologic malignancies, and other human therapeutic uses. 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 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.
Imetelstat (GRN163L) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, 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. Imetelstat has not been approved for marketing by any regulatory authority.
Geron is a clinical-stage biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information, visit www.geron.com.
Total Page Views: 1525
