Challenging Merck's BCG Monopoly: ImmunityBio Partners with SII

ImmunityBio has recently secured FDA approval for its immunotherapy drug, Anktiva, used in combination with Bacillus Calmette-Guérin (BCG) to treat non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). This milestone positions ImmunityBio to compete directly with Merck's Keytruda and Ferring Pharmaceuticals' Adstiladrin, which are used without BCG. However, the global shortage of BCG, with Merck as the only supplier in the U.S., presents a substantial obstacle.

The global market for BCG is dominated by a handful of companies. According to GlobalInfoResearch, seven manufacturers produce BCG worldwide: Merck, Sanofi Pasteur, Japan BCG Laboratory, China National Biotec Group, Serum Institute of India (SII), Intervax, and GSBPL. Among these, only Merck, Japan BCG Laboratory, China National Biotec Group, Serum Institute of India, and GSBPL continue to produce intravesical BCG. Sanofi, facing production issues, left the market in 2012, making Merck the primary global supplier of BCG.

Merck has adopted a controlled supply strategy since 2019, distributing limited quantities of BCG to distributors and wholesalers based on historical purchasing patterns. In October 2020, Merck announced plans to build a new TICE BCG production facility in North Carolina, expected to be operational between late 2025 and late 2026. This new facility aims to double the production capacity of BCG to meet future demand.

Despite the competitive landscape, ImmunityBio has an advantage. The FDA approval for Anktiva does not mandate the use of Merck's TICE BCG, allowing ImmunityBio to consider alternative BCG sources. ImmunityBio has formed an exclusive agreement with the Serum Institute of India, the world's largest BCG manufacturer, to produce BCG on a global scale. Details regarding the pricing and terms of this agreement remain undisclosed.

The Serum Institute of India offers two BCG products for cancer treatment. The first is Onco-BCG, a traditional BCG that has been commercialized outside the United States. The second is a recombinant BCG undergoing mid-term trials in Europe, designed to enhance immunogenicity under CD8+ and CD4+ stimulation while improving safety compared to standard BCG.

Both ImmunityBio and the Serum Institute of India are working to accelerate the second phase of clinical trials, although the timeline for commercial supply is still uncertain. ImmunityBio is optimistic that a clearer timeline will be established once the trial protocol is submitted to the FDA.

The collaboration between ImmunityBio and the Serum Institute of India represents a critical step toward addressing the chronic BCG shortage. By diversifying BCG production sources, ImmunityBio aims to provide a sustainable solution for NMIBC treatment with Anktiva. With the Serum Institute of India's extensive expertise and global reach, this partnership holds the potential to meet the growing demand for BCG and advance cancer therapies.