Post by imz72 on Mar 29, 2017 0:28:08 GMT
Key BioTime Patents Upheld by European Patent Office
EPO Rules Patents for OpRegen® are Valid and Remain in Force as Granted
OpRegen® is in Development to Treat Dry-AMD
ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 28, 2017-- BioTime, Inc. (NYSE MKT:BTX), a clinical stage biotechnology company developing and commercializing products addressing degenerative disease, today announced the successful defense of two key patents from challenge before the European Patent Office (EPO) Opposition division. A large pharmaceutical company and an anonymous filer challenged the EPO’s previous grant of two European patents (EP2554661 and EP2147094), which cover the proprietary directed differentiation methods to produce pluripotent stem cell-derived cell replacement therapies being developed to treat retinal degenerative diseases such as age-related macular degeneration (“AMD”). BioTime addressed the challenges at the EPO headquarters in Munich, Germany during public oral hearings, which took place March 16 -17, 2017.
“The EPO's decision to uphold these patents protecting OpRegen reinforces BioTime’s ability to defend its intellectual property and patent portfolios, which is one of the largest in the pluripotent cell therapy industry,” said Stephana Patton, General Counsel of BioTime, Inc. “The patents in question are a key component of the intellectual property (IP) assets our subsidiary, Cell Cure Neurosciences Ltd., secured through license from Hadasit Medical Research Services and Development Ltd. They have broad and significant claims describing directed differentiation, which we believe are critical for the development and commercialization of pluripotent cell-based therapeutics aimed at the dry form of AMD. BioTime’s IP estate remains a cornerstone in our efforts to advance the development and commercialization of pluripotent cell-based therapies for patients in need.”
OpRegen is an investigational therapy in which retinal pigment epithelial (RPE) cells are transplanted into the subretinal space, where they are intended to replace missing RPE cells. The ongoing trial is a Phase I/IIa dose-escalation study evaluating the safety and efficacy of three different dose regimens of OpRegen in patients with the advanced form of dry-AMD accompanied by geographic atrophy. Data recently presented from the first patient cohort indicate that, at the first dose, OpRegen caused no serious adverse events, and retinal imaging suggests the presence and survival of transplanted cells in the subretinal space for up to one year. Data from the cohort were presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) in Rome, on December 2, 2016 and at Bascom Palmer Eye Institute’s annual Angiogenesis meeting in Miami, Florida on February 11, 2017. Additional data will be presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Baltimore, Maryland on May 8, 2017. OpRegen has received Fast Track designation from the Food and Drug Administration (FDA) for treatment of the advanced form of dry age-related macular degeneration (dry-AMD). Details of the trial and about a patient’s eligibility are available at clinicaltrials.gov/ with the following Identifier: NCT02286089 (dry-AMD).
investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-newsArticle&ID=2256827
EPO Rules Patents for OpRegen® are Valid and Remain in Force as Granted
OpRegen® is in Development to Treat Dry-AMD
ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 28, 2017-- BioTime, Inc. (NYSE MKT:BTX), a clinical stage biotechnology company developing and commercializing products addressing degenerative disease, today announced the successful defense of two key patents from challenge before the European Patent Office (EPO) Opposition division. A large pharmaceutical company and an anonymous filer challenged the EPO’s previous grant of two European patents (EP2554661 and EP2147094), which cover the proprietary directed differentiation methods to produce pluripotent stem cell-derived cell replacement therapies being developed to treat retinal degenerative diseases such as age-related macular degeneration (“AMD”). BioTime addressed the challenges at the EPO headquarters in Munich, Germany during public oral hearings, which took place March 16 -17, 2017.
“The EPO's decision to uphold these patents protecting OpRegen reinforces BioTime’s ability to defend its intellectual property and patent portfolios, which is one of the largest in the pluripotent cell therapy industry,” said Stephana Patton, General Counsel of BioTime, Inc. “The patents in question are a key component of the intellectual property (IP) assets our subsidiary, Cell Cure Neurosciences Ltd., secured through license from Hadasit Medical Research Services and Development Ltd. They have broad and significant claims describing directed differentiation, which we believe are critical for the development and commercialization of pluripotent cell-based therapeutics aimed at the dry form of AMD. BioTime’s IP estate remains a cornerstone in our efforts to advance the development and commercialization of pluripotent cell-based therapies for patients in need.”
OpRegen is an investigational therapy in which retinal pigment epithelial (RPE) cells are transplanted into the subretinal space, where they are intended to replace missing RPE cells. The ongoing trial is a Phase I/IIa dose-escalation study evaluating the safety and efficacy of three different dose regimens of OpRegen in patients with the advanced form of dry-AMD accompanied by geographic atrophy. Data recently presented from the first patient cohort indicate that, at the first dose, OpRegen caused no serious adverse events, and retinal imaging suggests the presence and survival of transplanted cells in the subretinal space for up to one year. Data from the cohort were presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) in Rome, on December 2, 2016 and at Bascom Palmer Eye Institute’s annual Angiogenesis meeting in Miami, Florida on February 11, 2017. Additional data will be presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Baltimore, Maryland on May 8, 2017. OpRegen has received Fast Track designation from the Food and Drug Administration (FDA) for treatment of the advanced form of dry age-related macular degeneration (dry-AMD). Details of the trial and about a patient’s eligibility are available at clinicaltrials.gov/ with the following Identifier: NCT02286089 (dry-AMD).
investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-newsArticle&ID=2256827