The amended agreements provide ProMetic back with the effective control of NantPro and a greater portion of the future value and revenues associated with the development and sales of IVIG in the US market.
Pursuant to the original agreements and NantPharma’s expected additional capital contribution, ProMetic’s equity ownership position in NantPro would have been diluted down to 10% upon filing of the Investigational New Drug (IND) application for IVIG expected to take place in the second half of 2014.
As a result of the revised and amended agreements, ProMetic’s equity position in NantPro now exceeds 60%, and said position shall further increase by the time this milestone is achieved.
This follows the recent announcement of the successful Pre-Investigational New Drug (Pre-IND) meeting with the US Food and Drug Administration (FDA) focusing on ProMetic’s proprietary ssPlasma Protein Purification System (PPPS) manufacturing process as well as the clinical and regulatory pathway for IVIG.
ProMetic president and CEO Pierre Laurin noted that regaining control of NantPro and its IVIG development program is representative of our transition towards becoming a vertically integrated specialty biopharmaceutical company.
"As we step up our manufacturing and development activities, we anticipate advancing ourselves more of our high value plasma-derived therapeutics," Laurin added.
The production of GMP bioequivalence clinical trial material is currently underway in ProMetic’s plasma purification facility and the corporation expects to commence enrolling patients for the clinical trial in the fourth quarter of 2014. Following its Pre-IND meeting, Prometic is targeting market approval in the US for IVIG in the second half of 2017.
As part of the NantPro restructuring, NantPharma has assigned to ProMetic all of its intellectual property rights in connection with another plasma derived biopharmaceutical product under development with ProMetic.
The parties have agreed that some financial considerations related to said product will be rolled into NantPro. ProMetic remains responsible for the development and manufacturing of this second plasma derived biopharmaceutical product, for which the current global market is estimated to be worth $500m per year.