CorMedix Inc. ("CorMedix") (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced it has amended its agreement with Shiva Biomedical, LLC ("Shiva").
Under the amended license agreement, CorMedix and Shiva have mutually agreed to extend the development obligation milestone for the initiation of patient dosing in a phase III pivotal trial for CRMD001 from September 30, 2011 to March 31, 2012 and in addition enable the development of the diagnostic technology (CRMD002) independently of CRMD001. Additionally, the amendment extends and reallocates an existing $1 million milestone payment by the Company to Shiva upon the dosing of a patient in a phase III pivotal study. Now, under the terms of the amendment, the Company is obligated to pay Shiva $100,000 in September 2011, with additional payments of $450,000 to be made on or about December 31, 2011 and March 31, 2012, provided the Company elects to pursue the phase III pivotal development of CRMD001. As consideration for the extensions, the Company has granted Shiva a first security interest to the Company's licensed intellectual property from Shiva.
The Company recently completed the CRMD001 phase II biomarker, proof of concept study for the prevention of contrast induced acute kidney injury in high-risk patients with chronic kidney disease.
"We are pleased to have obtained extensions to both the development and financial obligations with Shiva. These extensions will enable us to effectively analyze the phase II data for CRMD001 that is expected to be announced by the end of the third quarter 2011 and pending those results, it will allow us to prudently plan for the potential phase III pivotal trial expected to begin during the first half of 2012," commented John C. Houghton President and Chief Executive Officer.
Phase 3 trial assesses clazakizumab in kidney transplant recipients with caAMR