Further EU Marketing Authorizations for AMW’s Leuprorelin Implant for the Treatment of Hormone-Sensitive Tumors
AMW GmbH, a pharmaceutical company specializing in innovative drug delivery systems, announced today that the leuprorelin implant it developed has received additional marketing approvals in two European Union countries. Leuprorelin enables symptomatic therapy of hormone-sensitive tumors, such as prostate cancer, and of certain gynecological diseases. AMW’s leuprorelin implant is now approved as a cost-effective therapy in over ten countries worldwide.
Warngau, December 22, 2022
AMW GmbH, a specialty pharmaceutical company focused on innovative sustained-release drug delivery systems, today announced that its leuprorelin implant has received market authorization in two EU countries. Leuprorelin enables symptomatic therapy of hormone-dependent tumors, such as prostate cancer, as well as certain gynecological disorders. AMW’s leuprorelin implant is now approved in more than 10 countries worldwide as a cost-effective therapy.
AMW develops and produces innovative, biodegradable sustained-release drug delivery systems, such as the GnRH analogue implants goserelin and leuprorelin. For global commercialization, the products are licensed to international and regional partners. AMW is the exclusive manufacturer and provider of these implants and receives royalties on licenses from its partners. In Germany, AMW’s wholly owned subsidiary Endomedica GmbH markets leuprorelin under the trade name Leugon®.
“Being able to now offer an easy-to-use leuprorelin option to both physicians and patients in an increasing number of European countries is a significant achievement for us and for our pharma partners,” said Dr. Andrey Molchanov, Vice President Business Development & Regulatory Affairs of AMW. “We are working hard to ensure that further approvals of our products will follow soon, within the EU and beyond.” Dr. Konstantin Petropoulos, CEO of AMW, added: “We continue to see a great demand and need of robust supply for cost-effective treatments and value-added medicines of this drug class, particularly in Europe. As a market leader for biodegradable sustained-release products, we cooperate closely with our partners to offer such therapies to as many patients as possible.”
About AMW:
AMW GmbH is a specialty pharmaceutical company focused on biodegradable sustained-release drug delivery systems, providing patients and partners access to value-added medicines and cost-effective therapies. Based on its technology platform, the Company builds on a growing own and partnered development pipeline. AMW has two approved products, goserelin and leuprorelin implants, which are distributed worldwide through both local and global pharma partners. In Germany, leuprorelin is marketed as Leugon® by AMW’s wholly owned subsidiary Endomedica GmbH. To support pharma and biotech partners in the development and manufacturing of their products and life-cycle solutions, AMW uses its leading-edge formulation development expertise.
AMW is based in Warngau near Munich, Germany.
About Leuprorelin:
Leuprorelin implants contain the active ingredient leuprorelin and belong to the class of GnRH agonists (analogues of gonadotropin releasing hormone) which interfere with the regulation of sex hormone balance. As a consequence, testosterone levels are lowered in men and estradiol levels are lowered in women. This artificially induced lowering of hormone levels enables the symptomatic therapy of hormone-dependent tumors such as prostate cancer or breast cancer. Leuprorelin is administered in the form of a biodegradable implant that releases the active ingredient over a period of three months.
For further information please contact:
AMW GmbH
Dr. Konstantin Petropoulos
Phone: +49 8024 470999-0
E-mail: news@a-m-w.eu