Robert Blum, President and Chief Executive Officer
Thank you Sharon and thank you all for joining us, this morning! On December 23rd, 2014 we announced that Cytokinetics and Astellas expanded our collaboration to enable the development of CK-2127107 or CK-107 in spinal muscular atrophy or SMA and also to provide for its potential development in other neuromuscular indications. We have previously been jointly conducting research and development activities with the objective to advance novel skeletal sarcomere targeted therapies for diseases and medical conditions associated with muscle weakness in non-neuron muscular indications. With the expansion of our collaboration, we have agreed that Cytokinetics will conduct a phase 2 clinical trial of CK-107 in patients with SMA. This trial is planned to begin later this year 2015. Under the expanded collaboration Cytokinetics and Astellas will jointly develop and may jointly commercialize CK-107 and other fast skeletal troponin activators in neuromuscular indications.
Additionally we have extended our joint research program focused on the discovery of noble scalpel sarcomere activators to the end of 2016. Cytokinetics and Astellas initially entered into collaboration in 2013 when we exclusively licensed two Astellas’ rights to co-develop and commercialize CK-107 for potential applications in non-neuromuscular indications. In accordance with initial scope of the collaboration Cytokinetics completed 5 Phase 1 clinical trials and other Phase 2 readiness activities and delivered a data package pertaining to these activities to Astellas in 2014. Following Cytokinetics and Astellas joint review of this data and subsequent to market research, regulatory manufacturing and clinical development planning, the companies agreed to advance CK-107 in to Phase 2 clinical development initially in SMA in connection with the expanded collaboration. The development program for CK-107 under the collaboration may also include other neuromuscular as well as other non-neuromuscular indications in the future.
Under the amended collaboration Astellas has exclusive rights to commercialize CK-107 and other fast skeletal troponin activators in non-neuromuscular indications and certain neuromuscular indications including SMA and other novel mechanisms skeletal muscle activators in all indications. All subject to certain Cytokinetics development and commercialization rights Cytokinetics may co-promote and conduct other certain commercial activities in both North America and Europe under agreed scenarios. The moment Fady would elaborate on objectives and key activities in both research and development under our expanded collaboration with Astellas and Sharon will review the financials of this expanded deal. However before they do so, I should point out that Tirasemtiv is not a part of this collaboration. Cytokinetics will continue to independently develop Tirasemtiv our first in class fast skeletal troponin activator which recently completed a phase 2 clinical trials program for the potential treatment of Amyotrophic Lateral Sclerosis or ALS.
To be clear, this expanded deal does not represent a departure from our potential commitment to Tirasemtiv nor to our resolve to bring forward the potential next treatment for ALS rather instead this collaboration affords us the opportunity to continue to expand our research and development of next generation skeletal muscle activators with the leading pharmaceutical company dedicated to this area biology and with commitment to investigate it’s broader potential that we could practically do ourselves. We are very pleased with the progress of our collaboration with Astellas and with Astellas’ strategic vision associated with the R&D of skeletal muscle activators increasing the scope of our collaboration to include the treatment of neuromuscular diseases that may also benefit from our novel mechanism approach. Provides us with an opportunity to continue to fully explore this new frontier of muscle biology. With that I will now turn the call over to Fady.
