Recordati: Licence obtained from Tolmar International for Eligard treatment of advanced prostate cancer in EU, Russia and Turkey.

Recordati announces the closing of a License and Supply Agreement with Tolmar International Ltd, to commercialise Eligard (leuprorelin acetate), in Europe, Turkey, Russia and other countries. Eligard is a marketed medicinal product for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy. The active ingredient of Eligard®is leuprorelin acetate, a powder which is solubilized with a solvent for subcutaneous injection. Eligard is available in three different dosages (for 1-month, 3-month and 6- month treatment, respectively) as a single kit containing two syringes. The development of a new device to administer the product which is easier to handle is currently ongoing, following the request from EMA. The regulatory variation is expected to be submitted by 31 October 2021. The product has been commercialized by Astellas in the territories licensed to Recordati, with annual sales in the region of approximately € 100 million. Tolmar will manufacture the product for Recordati, while Astellas will provide to Recordati certain transitional services for an agreed period of time. Recordati will make an upfront payment of € 35 million to Tolmar which will also be eligible to receive additional milestone payments up to a total of € 105 million as well as royalties on sales..