TOKYO--(BUSINESS WIRE)--#Avigan--CMIC HOLDINGS Co., Ltd. (Head Office: Tokyo, Minato-ku, Representative Director & CEO Kazuo Nakamura, hereafter “CMIC”) announced today that CMIC is providing monitoring services as a CRO (Contract Research Organization) for “Avigan^® Tablet” (generic name: favipiravir), a product that FUJIFILM Toyama Chemical Co., Ltd. (hereafter “FUJIFILM”) gained approval in Japan for manufacture and sale as an influenza antiviral drug, phase III clinical trial in Japan and will support for manufacturing the product as a CDMO (Contract Development & Manufacturing Organization).

Recently, FUJIFILM announced the start of clinical trials of Avigan in Japan and overseas as one of the drug candidates for COVID-19. In addition, the Japanese government plans to stockpile two million treatment courses* of Avigan, as part of the Japanese government's emergency economic package.

On the back of the efforts to fight against COVID-19 pandemic, CMIC group supports the phase III clinical trial at CMIC Co., Ltd., a pioneer CRO in Japan. Also, CMIC CMO Co., Ltd., a leading CDMO in Japan, will manufacture “Avigan^® Tablet” at their main plant to contribute that FUJIFILM Corporation accelerates the production.

CMIC group will continue to show our strong supports to pharmaceutical companies and medical professionals and contribute to the medical care and health of people suffering from COVID-19. By using our unique business model “Pharmaceutical Value Creator (PVC)” which covers the value chain of pharmaceutical companies, CMIC group will work to contribute to providing COVID-19 related services below.

COVID-19 Clinical Trial/Research Related Services

• Consulting service, monitoring, data management, statistical analysis, medical writing, pharmacovigilance and audit/quality assurance for clinical trials and clinical research of medicine and vaccine for targeting COVID-19
• Establish and operate diseases database
• Dispatch specialists who have accumulated experiences in works of clinical operations
• Support of clinical research and clinical trial in medical institutions as SMO (Site Management Organization)

Customer Support for Clinical Trial/Research of COVID-19

For inquiries, please contact our customer support below.

Email: [email protected]

*A treatment course is the amount of Avigan Tablet described by the Japanese Association for Infectious Diseases in its guidance for a regimen of favipiravir to treat COVID-19. This 14-day treatment regimen includes: two loading doses of 1800 mg each on Day 1, followed by two maintenance doses of 1000 mg each on Days 2 through 14.

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About "Avigan^® Tablet"

Avigan Tablet was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug for novel or re-emerging influenza virus infections. Japanese government has a certain stock pile of the drug as a countermeasure against such influenza viruses.

About CMIC Group

CMIC Group was founded in 1992 as the first Contract Research Organization (CRO) in Japan. Today CMIC Group is the largest clinical CRO in Japan with global footprint, providing comprehensive services in drug development, clinical site management, clinical to commercial GMP manufacturing, regulatory consulting and contract sales & marketing solutions. We can help pharmaceutical, biotech and medical device companies to enter Japan market, to conduct clinical trials in Asia, or to bridge drug development and manufacturing needs in the US, Europe, Japan and broader Asia. CMIC Group has over 7,000 employees and 25 sites globally.

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CMIC HOLDINGS Co., LTD.

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Yuko Ishikawa

E-mail: [email protected]