On August 13, 2014 TNI BioTech reported the signing of a supplemental agreement with Hubei Qianjiang Pharmaceutical on behalf of Cytocom, TNI BioTech’s wholly owed subsidiary. The signing of the supplemental agreement accelerates clinical trial development in both America and China, for IRT-101 ("MENK") (Press release TNI BioTech, AUG 13, 2014, View Source [SID:1234501362]). In the hope of moving clinical development forward the parties agreed to the following:
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– The parties agree to immediately initiate 3-mo GLP Toxicology Studies within 30 days of the signing of this agreement. GLP Toxicology Studies Trials will be run in China in accordance with international standards and acceptable to the FDA
– Qianjiang Pharmaceutical has raised the funds necessary for clinical development and marketing of MENK. Expenditures are subject to full budget approval by both Qianjiang and Cytocom and will be approved by Mr. Ye Jige, of Qianjiang Pharmaceutical, and, authorized by Noreen Griffin, CEO of TNI BioTech of the United States.
– Cytocom and Qianjiang Pharmaceutical will meet immediately with the SFDA to determine that PK and Dosing Trials completed in the US will be acceptable to the SFDA. All developments and trial results run by Cytocom in the United States or EU will be used for requesting registration approval in China
– Based on PK, Dosing and Existing Trial results in US, Qianjiang pharmaceutical and Dr. Graham Burton and Dr. Joseph Fortunak will meet with the SFDA to determine what additional data will be required to initiate corresponding trial in China.
The partnership will leverage the expertise and distinct assets and capabilities of each company in its respective field, namely Cytocom’s expertise in drug development, and Hubei’s financial, manufacturing and distribution capabilities.
Integrating these capabilities, the companies will utilize the collaboration’s joint assets to develop and commercialize products. The parties have agreed on revenue sharing from all MENK products developed through the collaboration.
Noreen Griffin and CEO of TNIB states, "This expansion of our agreement with Hubei today allows Cytocom to immediately move forward with our development plan for MENK. We expect our joint efforts will result in significant product and revenue opportunities for both Cytocom and Hubei."
Chairman and President of Hubei Mr. Ye Jige, commented, "This collaboration with TNIB and Cytocom continues Hubei Qianjiang Pharmaceutical’s strategy to develop new products and to speed up the product commercialization process for our partners. This is the first step of the collaboration."