CytoDyn, Samsung BioLogics Enter Mfg. Agreement

CytoDyn, a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, has formed an agreement with Samsung BioLogics for the clinical and commercial manufacturing of leronlimab. The quantity of new leronlimab to be produced under the agreement is anticipated to be sufficient to support potential revenues for CytoDyn of approximately $1 billion based upon $120,000 per patient, per year.
 
The agreement commences immediately and entails, most notably, technology transfer of the fully validated commercial process and scale-up, large scale commercial production, validation, and regulatory support during the pre- and post- approval process with the U.S. Food and Drug Administration (FDA) and other global regulatory bodies. In the last four years, Samsung BioLogics has secured 8 biologics drugs approvals from the FDA and 22 overall when including other agencies around the world.
 
It is believed the financial obligation to Samsung will be satisfied predominantly with sales from existing inventory of commercial grade leronlimab and non-dilutive financing. The initial contract period is from April 1, 2019 to December 31, 2027, encompassing the multitude of potential indications for leronlimab (PRO 140) for which CytoDyn anticipates pursuing regulatory approvals.
 
"We are elated at the distinction of partnering with the world’s preeminent biologics manufacturer for our franchise-defining drug," said Nader Pourhassan, president, chief executive officer and director, CytoDyn. "In the last four years, Samsung BioLogics has been among the most successful, consistent and highest quality biologics manufacturers in the world."

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