TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') today announced that its subsidiary, Astellas Pharma Europe Ltd. ('Astellas Europe'), and Tolmar International Limited ('Tolmar') have entered into an agreement in which Astellas Europe will return the in-licensing rights to 'EligardTM (leuprolide acetate for injectable suspension)' a treatment for advanced prostate cancer sold by Astellas Europe in Europe, the Middle East, the Commonwealth of Independent States (CIS)1 , and Asia, to Tolmar, and that the closing of the transaction happened on January 29.
Astellas Europe has also entered into an agreement with Recordati Industria Chimica e Farmaceutica S.p.A. ('Recordati'), who has entered into a license and supply agreement with Tolmar to commercialize EligardTM in Europe, Turkey, Russia and other territories. As a result, Recordati is taking over the Astellas position as EligardTM licensee in these territories. Astellas will provide to Recordati certain transitional services for an agreed period of time, in order to ensure a smooth transfer of the product and stable delivery to the patients.
EligardTM is a luteinizing hormone-releasing hormone (LHRH) agonist developed by Tolmar. In-licensed from Tolmar, Astellas Europe launched EligardTM in Europe in 2004 and later expanded its distribution to the Middle East, the CIS, and Asia.
The agreement with Tolmar is a part of Astellas' ongoing efforts to improve the quality and efficiency of operations so as to accommodate a rapidly changing business environment and achieve sustainable growth. Astellas will continue to strengthen its business presence in Europe, the Middle East, CIS, and Asia through optimization of resource allocation.
The impact of this transaction on Astellas' financial results for the fiscal year ending March 31, 2021 is expected to be minor.
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.
About Tolmar International
Along with its U.S. affiliated companies, is a fully integrated pharmaceutical company focused on the innovative development, manufacturing and commercialization of specialty pharmaceuticals. Tolmar International is headquartered in Ireland with manufacturing sites in the U.S
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations throughout the whole of Europe, including Russia, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases. Consolidated revenue for 2019 was EUR 1,481.8 million, operating income was EUR 465.3 million and net income was EUR 368.9 million.
Cautionary Notes (Astellas)
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.