Tazemetostat Production Cost Reports

The report provides a detailed analysis essential for establishing a tazemetostat production plant. It encompasses all critical aspects necessary for tazemetostat production, including the cost of tazemetostat production, tazemetostat plant cost, tazemetostat production costs, and the overall tazemetostat production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a tazemetostat production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Tazemetostat works as a targeted EZH2 inhibitor, which is approved for treating relapsed or refractory follicular lymphoma with specific EZH2 mutations. It is used in patients who have exhausted at least two prior systemic therapies or lack suitable alternatives, where it restores normal gene expression to shrink tumours. It is also indicated for locally advanced or metastatic epithelioid sarcoma in adults and pediatric patients aged sixteen and older, ineligible for complete resection. It shows clinical activity by blocking abnormal epigenetic silencing that drives cancer growth. It is also utilized for overcoming daratumumab resistance in multiple myeloma through upregulation of CD38 and CD48 on cancer cells to boost immune cytotoxicity. It is also applied in combinations like mezigdomide plus dexamethasone for refractory myeloma cases.

The market for tazemetostat is driven by the increasing incidence of EZH2-mutated cancers like follicular lymphoma and epithelioid sarcoma. The clinical investigation into novel oncology uses, along with the rise in precision medicine strategies, boosts its market. The investments from pharmaceutical companies and governments, elevated cancer rates, sophisticated healthcare systems, and favourable reimbursement frameworks contribute to its market growth. The high production expenses for pure formulations, rigorous oncology drug regulations, and rivalry from new EZH2 blockers or other cancer options impact industrial tazemetostat procurement. The supply chain difficulties for niche providers, instability in prices because of concentrated supplier landscapes, and requirements for diagnostics to find eligible patients influence its market dynamics.

Raw Material for Tazemetostat Production

According to the tazemetostat production plant project report, the key raw materials used in the production of tazemetostat include 2-methyl-3-nitrobenzoic acid, dibromantin, 4-oxanone, acetaldehyde, and boronate ester.

Production Process of Tazemetostat

The extensive tazemetostat production cost report consists of the following major industrial production process:

1. From 2-methyl-3-nitrobenzoic acid: The production process of tazemetostat starts with 2-methyl-3-nitrobenzoic acid as the starting material. This goes through bromination with dibromantin in sulfuric acid, followed by esterification and nitro group reduction to yield an aniline intermediate. This is followed by two sequential reductive aminations, i.e. one with 4-oxanone and another with acetaldehyde to form a dialkylarylamine intermediate. After that, Suzuki coupling with a boronate ester takes place, followed by saponification, and final amide bond formation with a specific benzylamine. Finally, treatment with aqueous hydrobromic acid gives tazemetostat hydrobromide as the final product.

Tazemetostat is a white to off-white powder with a molecular formula of C34H44N4O4 (free base) or C34H45BrN4O4 (hydrobromide salt). It has the molecular weight of 572.75 g/mol (free base) or 653.6 g/mol (salt). It has 9 rotatable bonds, 3 hydrogen bond donors, 6 acceptors, and a topological polar surface area of 83.1 Ų. It shows low aqueous solubility typical of lipophilic small molecules, and is stable when stored at -20 °C or refrigerated. It has oral bioavailability of about 33%, unaffected by high-fat meals, with rapid absorption (Tmax 1-2 hours) and no stereocenters. It has a biphenyl carboxamide core with morpholinylmethyl, ethyl(tetrahydropyran)amino, and dimethyl-oxopyridinylmethyl substituents.