ImmunityBio Partners with Serum Institute of India to Counter Merck's BCG Monopoly Amid Global Shortages

Recently, ImmunityBio has received FDA approval for its immunotherapy Anktiva in combination with Bacillus Calmette-Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).

This means that ImmunityBio will directly compete with Merck & Co., Inc.'s PD-1 blockbuster drug Keytruda and Ferring Pharmaceuticals' gene therapy drug Adstiladrin, both of which are self-administered without the need for BCG. However, it is important to note that BCG has been in a persistent global shortage, and Merck & Co., Inc. is currently the sole supplier of BCG in the United States.

BCG was initially developed as a tuberculosis vaccine and is also the standard treatment for NMIBC. Currently, there are two main types of BCG on the market: immune type and therapeutic type. According to GlobalInfoResearch's "2023 Global Market Intravesical BCG Overall Scale, Major Manufacturers, Major Regions, Product and Application Segmentation Research Report," there are seven companies worldwide producing BCG: MSD, Sanofi Pasteur, Japan BCG Lab, China National Biotech, Serum Institute of India, Intervax, and GSBPL. Among them, only MSD, Japan BCG Laboratory, China National Biotech, Serum Institute of India, and GSBPL are currently capable of producing intravesical BCG.

Since Sanofi and another pharmaceutical company encountered production issues in 2012, MSD's TICE BCG has become the only BCG product in the U.S., dominating the market. After Sanofi officially exited the market in 2016, MSD effortlessly secured its position as the primary global supplier of BCG. Since 2019, MSD has implemented a quota system for BCG supplies, distributing the limited quantities to distributors and wholesalers based on historical purchasing data, rather than directly determining product allocation for individual healthcare providers.

In October 2020, MSD announced plans to build a new TICE BCG production facility in North Carolina. According to MSD's update in January this year, the project is expected to be completed between the end of 2025 and the end of 2026. Once operational, MSD anticipates that BCG production capacity will triple and believes it will be able to meet supply demands for the foreseeable future.

From the above, it is certain that ImmunityBio is constrained by direct competitors. However, there is still good news. The current approval of Anktiva in the United States does not specify or restrict the type of BCG vaccine that can be used with the drug. This allows ImmunityBio to explore other alternatives to Merck's TICE BCG. Now, this California-based biotechnology company has reached an exclusive agreement with the Serum Institute of India (SII) — the price and detailed terms of the agreement have not been disclosed yet — to produce BCG globally. ImmunityBio stated that the agreement aims to provide a long-term solution to the chronic BCG supply shortage and to produce BCG on a "large scale" for use in combination with Anktiva to treat non-muscle invasive bladder cancer (NMIBC).

According to ImmunityBio, the SII is the world's largest BCG manufacturer. This Indian company has two BCG products for tumor treatment: one is the traditional BCG called Onco-BCG, which has already been commercialized outside the United States. Once the FDA approves the trial protocol, SII will immediately provide standard BCG for ImmunityBio’s clinical trials, and ImmunityBio plans to submit it to global regulatory authorities within 30 days.

The second product is recombinant BCG, which is currently in mid-stage trials in Europe. This version includes two genetic modifications to enhance its properties and, according to ImmunityBio, "demonstrates potent immunogenicity under CD8+ and CD4+ stimulation compared to standard BCG, with improved safety." The two partners are now working to accelerate the phase two trials.

However, in both cases, the timeline for commercial supply remains unclear. But ImmunityBio, Inc. stated, "There will be a clearer timeline once the trial protocol is submitted to the FDA."

Source: FierceBiotech

Editor: Baiji

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