Recordati gains rights to Eligard in Europe and some other territories

Italian drugmaker Recordati (RECI: MI) has announced the closing of a license and supply agreement with Tolmar International, to commercialize Eligard (leuprorelin acetate) in Europe, Turkey, Russia and other countries.

Eligard, 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, 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 European Medicines Agency. The regulatory variation is expected to be submitted by October 31, 2021.

The product has been commercialized by Japan’s Astellas Pharma (TYO: 4503) in the territories licensed to Recordati, with annual sales in the region of around 100 million euros ($121 million). Tolmar will manufacture the product for Recordati, while Astellas will provide to Recordati certain transitional services for an agreed period of time.