ImmunityBio Enters Exclusive U.S. Supply Agreement for Tokyo Strain of BCG

ImmunityBio, Inc. has entered into an exclusive development and supply agreement with Japan BCG Laboratory (JBL) to address the long-standing shortage of Bacillus Calmette-Guerin (BCG) in the United States. Under the agreement, JBL will exclusively manufacture and supply its Tokyo-172 strain of BCG for ImmunityBio to develop and commercialize in the U.S. and its territories.

Key Details

• Agreement: ImmunityBio gains exclusive rights to purchase, import, sell, and distribute JBL's Tokyo-172 strain of BCG in the U.S. for an initial term of 10 years following FDA approval.
• Responsibilities: ImmunityBio is solely responsible for all U.S. development, including clinical trials and obtaining regulatory approvals. JBL will exclusively manufacture and supply the product.
• Financial Terms: No payment is due to JBL prior to FDA approval. After approval, ImmunityBio has a minimum purchase commitment of at least two batches of the product per year.
• Supporting Data: The agreement is supported by a positive Phase III National Cancer Institute-sponsored study (SWOG S1602) that demonstrated the non-inferiority of the Tokyo strain compared to the TICE BCG strain for treating non-muscle invasive bladder cancer.