Warngau, August 9, 2023
AMW GmbH, a specialty pharmaceutical company focused on innovative sustained-release drug delivery systems, today announced that it has achieved a key milestone in opening new markets within the European Union (EU) and beyond with the final report of the first Notified Body Opinion (NBO) for its goserelin implant. The NBO completes an elaborate conformity assessment procedure by an authorized body, in this case TÜV SÜD. Thus, after official testing, the applicator of the goserelin implant complies with the requirements of the European legislation for combination products (Art 117 EU 2017/745 (MDR)), which has been in force since May 2021. The biodegradable goserelin implants release the active ingredient goserelin over a period of either one or three months.
“We are proud that a renowned testing body such as TÜV SÜD has issued the first NBO for a complex combination product of AMW after intensive examination”, commented Philipp Karbach, CEO of AMW. “This confirms the high quality of our product and now opens up the possibility of offering our goserelin implant to further patients in the EU and beyond as a high-quality and cost-effective treatment option for hormone-dependent tumors and gynecological disorders.”
Since May 26, 2021, an NBO (or CE marking for stand-alone medical devices) has been a mandatory part of a new EU approval process for integral drug-medicine device combinations, such as AMW’s goserelin and leuprorelin implants. This procedure requires accurate and detailed documentation demonstrating the functionality and safety of the applicator from release to end of life of the medicinal product based on detailed technical dossiers.
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.
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.
Goserelin implants contain the active ingredient goserelin 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. In addition, goserelin implant is used to treat certain benign gynecological disorders. Goserelin is administered in the form of a biodegradable implant which releases the active ingredient over a period of either one or three months.
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