Overcoming Merck's BCG Monopoly: ImmunityBio Joins Forces with SII

In recent developments, ImmunityBio has gained FDA approval for its immunotherapy drug, Anktiva, in combination with Bacillus Calmette-Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). This approval sets the stage for ImmunityBio to directly compete with Merck's heavyweight drug Keytruda and Ferring Pharmaceuticals' gene therapy drug Adstiladrin, both of which are administered without BCG. However, the global shortage of BCG, with Merck being the sole supplier in the United States, poses a significant challenge.

The Global BCG Market:

According to a research report by GlobalInfoResearch, there are currently seven companies worldwide that produce BCG: Merck, Sanofi Pasteur, Japan BCG Laboratory, China National Biotec Group, Serum Institute of India, Intervax, and GSBPL. Among them, Merck, Japan BCG Laboratory, China National Biotec Group, Serum Institute of India, and GSBPL are the remaining manufacturers of intravesical BCG. After facing production issues in 2012, Sanofi officially exited the market, leaving Merck as the global primary supplier of BCG.

Merck's BCG Supply Strategy:

Since 2019, Merck has been implementing a controlled supply of BCG, allocating limited quantities to distributors and wholesalers based on historical purchasing patterns rather than directly supplying individual healthcare providers. In October 2020, Merck announced plans to construct a new TICE BCG production facility in North Carolina, with an expected completion date between late 2025 and late 2026. Once operational, Merck anticipates doubling BCG production capacity to meet future demand.

ImmunityBio's Alternative Approach:

Although ImmunityBio faces direct competition from established rivals, there is a silver lining. The FDA approval for Anktiva does not specify or restrict the type of BCG used in conjunction with the drug. This allows ImmunityBio to explore alternative options to Merck's TICE BCG. The California-based biotechnology company has entered into an exclusive agreement with the Serum Institute of India (SII), the world's largest manufacturer of BCG, to produce BCG globally. The details of the agreement, including pricing and terms, have not been disclosed.

SII's BCG Products:

SII offers two BCG products for cancer treatment. The first is a traditional BCG known as Onco-BCG, which has already been commercialized outside the United States. The second product is a recombinant BCG currently undergoing mid-term trials in Europe. This version incorporates two gene modifications to enhance its immunogenicity under CD8+ and CD4+ stimulation, while improving safety compared to standard BCG.

Future Prospects:

Both ImmunityBio and SII are working diligently to expedite the second phase of clinical trials. However, the timeline for commercial supply remains uncertain in both cases. ImmunityBio has expressed confidence that once the trial protocol is submitted to the FDA, a clearer timeline will emerge.

The collaboration between ImmunityBio and SII marks a significant step towards addressing the chronic shortage of BCG supply. By diversifying the sources of BCG production, ImmunityBio aims to ensure a long-term solution for the treatment of NMIBC with Anktiva. With SII's expertise and global reach, the partnership holds promise in meeting the demand for BCG and advancing cancer therapies.