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Adalvo announces DCP approval for Enzalutamide Soft Gel capsules

11 May 2022

Adalvo is delighted to announce the successful EU DCP closure of our Enzalutamide Soft Gel Capsules.

Our product has been developed based on the reference brand Xtandi (Astellas) 40mg Soft Gel Capsules, which is currently the best-selling androgen receptor inhibitor, used in the treatment of prostate cancer. The product sold at around $2.1bn globally in 2021, according to IQVIA, with stable sales over the recent years. While Astellas has now presented their film-coated tablet version of the product, Xtandi Soft Gel Capsules still remains the main product being sold in several markets, worldwide. We are proud to add that the film-coated tablet version is also part of our portfolio so Adalvo will soon be able to cover on the full range of Enzalutamide products.

Our product has been developed by our sister company, Lotus, a state-of-the-art R&D and manufacturing facility, headquartered in Taiwan, which specializes in the development and manufacture of solid oral oncology products.

We believe to be the first Company to receive an EU approval,  and with this positive news, as soon as regulatory exclusivities and patents will expire, we will proceed to launch this product. With this approval, Adalvo can provide European CPP for markets, where this is required.

Disclaimer: Enzalutamide Soft Gel capsules which is subject to patent protection is currently not offered or made available in countries where patents are in force.