BTX: Teva Terminates Agreement to Develop OpRegen

8K on the termination:


www.sec.gov/Archives/edgar/data/876343/000115752315000580/a51041198.htm


Section 1 - Registrant’s Business and Operations

Item 1.01 - Entry into a Material Definitive Agreement.

On February 15, 2015, the option granted by our majority owned subsidiary Cell Cure Neurosciences Ltd. (“Cell Cure”) to Teva Pharmaceutical Industries Ltd. (“Teva”) under a Research and Exclusive Option Agreement (the “Option Agreement”), dated October 7, 2010, to license-in rights to complete the development and to commercialize Cell Cure’s OpRegen® product expired without having been exercised by Teva. As a result the Option Agreement has terminated. Cell Cure is continuing the clinical development of OpRegen and will be pursuing discussions with potential strategic partners, including those that have already indicated interest in participating in development and commercialization of the product.

See Item 8 below for additional recent developments concerning Cell Cure’s development of OpRegen.

Section 8 - Other Events

Item 8.01 - Other Events


On February 16, 2015, Cell Cure’s clinical trial of OpRegen opened at Hadassah University Medical Center in Jerusalem. The clinical trial is entitled “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy.” Patient enrollment is expected to begin shortly. OpRegen consists of animal product-free retinal pigment epithelial (RPE) cells with high purity and potency that were derived from human embryonic stem cells (hESCs) using a proprietary directed differentiated method, for which a new US patent No. 8,956,866 is expected to issue on February 17, 2015.

The Phase I/IIa clinical trial, will evaluate three different dose regimens of OpRegen. Following transplantation, the patients will be followed for 12 months at specified intervals, to evaluate the safety and tolerability of the product. Following the initial 12 month period, patients will continue to be monitored at longer intervals for an additional period of time. A secondary objective of the clinical trial will be to examine the ability of transplanted OpRegen to engraft, survive, and moderate disease progression in the patients. In addition to thorough characterization of visual function, a battery of ophthalmic imaging modalities will be used to quantify structural changes and rate of geographic atrophy expansion.

The new U.S. patent, entitled “Retinal Pigment Epithelial Cells Differentiated from Embryonic Stem Cells With Nicotinamide and Activin A” claims a proprietary method of enhancing the yield of retinal pigment epithelial cells which are the active ingredient of OpRegen.