Astellas Transfers DIFICLIR in Europe, Middle East, Africa and selected CIS to Tillotts Pharma

Astellas Pharma Inc. announced that the subsidiary Astellas Pharma Europe Ltd. and Tillotts Pharma AG have entered into an Asset Purchase Agreement, under which Astellas Europe will transfer its marketing authorizations for “DIFICLIRTM (generic name: fidaxomicin) tablets” for Clostridium difficile (CD) infections in Europe, Middle East, Africa and selected Commonwealth of Independent States (CIS) to Tillotts.

Financial Terms of Asset Purchase Agreement – €109 million.

After the closing of the agreement and according to transitional arrangements, Tillotts will take over DIFICLIRTM from Astellas and manufacture and sell it in Europe, Middle East, Africa and selected CIS. Astellas will continue to work with Tillotts Pharma to promptly transfer its marketing authorizations to ensure stable delivery of this product to patients.

DIFICLIRTM is a unique narrow-spectrum macrocyclic anti-bacterial agent available as film-coated tablets and granules licensed from a subsidiary of Merck & Co., Inc. Kenilworth, N.J., U.S.A., known as MSD outside the U.S. and Canada. Astellas Europe has been selling DIFICLIRTM in Europe since 2012 and expanded our sales area to the Middle East and Africa. Astellas will continue to sell Dafclir® tablets in Japan, where it has the marketing authorization for the treatment of infectious enteritis (including pseudomembranous colitis) (susceptible strains: fidaxomicin susceptible CD).

Astellas will continue to strengthen our business presence in Europe, Middle East, Africa and CIS through optimization of resource allocation.

After closing of the agreement, marketing authorization of the product will be transferred in each country.

Sales of the DIFICLIRTM in Europe, Middle East, Africa and selected CIS – €28 million (fiscal year ended March 31, 2020).

28.11.2020

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