Eisai inaugurates new facility for injectable drug formulation research

JAPAN – Eisai has inaugurated a research building dedicated to injectable drug formulation at the Kawashima Industrial Park in Gifu Prefecture, Japan.

The Eisai Medicine Innovation Technology Solutions (EMITS) facility will serve as Eisai’s global formulation and research headquarters.

The Kawashima Industrial Park is Eisai’s global pharmaceutical manufacturing base, at which Eisai has made a comprehensive framework comprising all steps from formulation research to formulation manufacturing.

Eisai has expanded its drug discovery targets beyond small molecules to include antibodies, antibody-drug conjugates (ADCs), and nucleic acid drugs.

The EMITS research facility will focus on injectable drug formulation and drug delivery systems. Eisai intends to investigate liposomal and lipid nanoparticle formulations in particular.

Eisai intends to use AI to improve drug formulation. It also intends to manufacture investigational injectable drugs for clinical trials at the facility and to develop rapid microbial testing methods for microbiological control and sterility assurance.

Finally, it intends to use the facility to facilitate collaborative research with outside partners. Eisai invested approximately 10 billion yen (roughly US$69.4 million) in the new facility.

Eisai recently made headlines when it announced positive topline data from a Phase 3 study of the antibody lecanemab in Alzheimer’s patients with its partner Biogen.

After 18 months, lecanemab slowed cognitive decline in early-stage Alzheimer’s patients by 27%, according to the companies.

Following the release of the data, the stock prices of both companies increased. While drug companies have long sought to develop amyloid-plaque-reducing therapies, none have succeeded in creating a drug that is widely used.

Although Biogen and Eisai received FDA approval for the contentious antibody Aduhelm (aducanumab), sales of the therapy have been disappointing.

Biogen and Eisai’s attempt to expand controversial Alzheimer’s disease drug Aduhelm also hit a snag in Japan, after the Japanese drug reviewers ruled that existing data didn’t support approval and are therefore seeking additional clinical data.

Japan’s rejection came less than a week after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rejected it.

The European Medicines Agency refused Aduhelm due to uncertainties in the drug’s effect on Alzheimer’s clinical progression, as well as concerns about a common and potentially life-threatening side effect known as amyloid-related imaging abnormalities.

The Centers for Medicare & Medicaid Services (CMS) decided in April 2022 to limit coverage for aducanumab to clinical trial participants.

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