ViaCyte Inc., a privately held regenerative medicine company announced today that it has entered into a Rights Agreement with Janssen Research & Development LLC (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01(TM) combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01. ViaCyte received $20 million from Janssen and Johnson & Johnson Development Corporation (JJDC). The payment included a rights fee and a note convertible into equity at a later date. JJDC has been a long-standing investor in ViaCyte.
This new infusion of capital, together with the recently announced $5.4 million private equity financing transaction, provides substantial additional resources for the further development of the Company’s stem cell derived islet replacement therapy for insulin-dependent diabetes. The Company plans to use the funds primarily to accelerate the clinical development of the VC-01 product candidate.
ViaCyte recently announced the allowance by the U.S. Food and Drug Administration of an Investigational New Drug application for the VC-01 product candidate, which will permit ViaCyte to begin clinical evaluation of the VC-01 product candidate for type 1 diabetes. ViaCyte plans to promptly initiate clinical development directly in patients with type 1 diabetes, seeking to evaluate both safety and efficacy in this first clinical study.
“These important transactions provide us with additional resources we need to pursue the further development of the VC-01 product candidate as a potential new treatment option for patients with type 1 diabetes,” said Paul Laikind, president and chief executive officer of ViaCyte. “We are pleased to be extending our relationship with Janssen and JJDC in this area of mutual interest.”
ViaCyte’s VC-01 product candidate consists of pancreatic progenitor cells, called PEC-01(TM) cells, which are derived from a proprietary human embryonic stem cell line, encapsulated in ViaCyte’s proprietary Encaptra device. When implanted under the skin, the PEC-01 cells are specifically designed to mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose in a manner similar or identical to the islets that normally comprise the endocrine pancreas.
Date: August 21, 2014