NewGLab Signs MSA Contract with Germany's Merck for Production of Anticancer Drug API

[Asia Economy Reporter Hyunseok Yoo] NewG Lab announced on the 21st that its U.S. subsidiary, NewG Lab Pharma Inc., has signed a Master Service Agreement (MSA) for the production of active pharmaceutical ingredients (API) with Sigma-Aldrich, a subsidiary of the multinational pharmaceutical company Merck KGaA.

NewG Lab Pharma has designated Sigma-Aldrich as the Contract Manufacturing Organization (CMO) for the clinical trials of its metabolic anticancer drug pipeline, KAT (kodiscovery anti-cancer technology), and will proceed with large-scale production of the raw pharmaceutical ingredients. According to the company, the first production of cGMP-certified API products (certified by the U.S. FDA for raw pharmaceutical manufacturing quality standards) is scheduled to be completed in April.

A company representative stated, “We began contract manufacturing of APIs through a Purchase Order (P/O) last July and have already completed the first non-GMP batch production (Qualification Run). Currently, the research-grade API produced by Sigma-Aldrich is being applied to preclinical and laboratory experiments, and we are preparing to scale up cGMP-grade API for FDA human clinical trials.”

Since its establishment in 1950, Sigma-Aldrich has been producing and supplying APIs and biochemical substances such as drugs, biologics, and reagents necessary for life science research. It is recognized as an international proficiency testing evaluation institution by organizations such as the International Organization for Standardization (ISO/IEC). In 2015, it was acquired and merged as a life sciences business subsidiary of the German multinational pharmaceutical group Merck. Currently, it operates more than 60 production facilities worldwide and supplies over 300,000 products. As of 2018, Merck’s global life sciences business recorded sales of 6.18 billion euros (approximately 8 trillion KRW).

NewG Lab Pharma’s API production will be conducted at Merck’s Buchs Site in Switzerland. The Buchs Site meets the highest regulatory standards, including the EU GMP Guide, FDA compliance, and ICH Q7. It currently has 30 multipurpose reactors (ranging from 50 to 1600 liters) and produces over 5,000 products.

A company representative explained, “NewG Lab Pharma plans to conduct clinical research for metabolic anticancer drug development using APIs produced at Merck’s Swiss Buchs Site, which meets global top-level facility and quality standards. Since APIs must meet strict quality standards (cGMP) for successful FDA clinical trials, we will work closely with Merck.”

They added, “The GLP-Tox (nonclinical toxicity testing) and PK study (pharmacokinetic study) of KAT are progressing smoothly with Covance, a global top CRO headquartered in New Jersey, USA. We plan to achieve visible results in metabolic anticancer new drug development this year.”