TOKYO, November 27, 2020 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that the subsidiary Astellas Pharma Europe Ltd. (“Astellas Europe”) and Tillotts Pharma AG (“Tillotts”) 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)1 infections in Europe, Middle East, Africa and selected Commonwealth of Independent States (CIS)2 to Tillotts.
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 agent3 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 colitis4) (susceptible strains: fidaxomicin susceptible CD).
(1) Purpose of Asset Purchase Agreement
The agreement is a part of Astellas’ ongoing efforts to improve the quality and efficiency of operations so as to accommodate the rapidly changing business environment and achieve sustainable growth. Astellas will continue to strengthen our business presence in Europe, Middle East, Africa and CIS through optimization of resource allocation.
(2) Financial Terms of Asset Purchase Agreement
(3) Schedule of Asset Purchase Agreement
November 24, 2020: Signing of the Asset Purchase Agreement
Third quarter of the fiscal year 2020: Closing of the Asset Purchase Agreement (tentative)
After closing of the agreement, marketing authorization of the product will be transferred in each country.
(4) Sales of the DIFICLIRTM in Europe, Middle East, Africa and selected CIS
€28 million (fiscal year ended March 31, 2020)
The impact from this transaction is not reflected in Astellas' consolidated financial forecasts for the fiscal year ending March 31, 2021. Since part of the consideration for the transfer is recognized as revenue during the current fiscal year, we expect a positive impact on revenue and operating profit.
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