Additional Market Authorizations for AMW’s Goserelin Implant for the Treatment of Hormone-Dependent Tumors in the EU and Central America

AMW GmbH, a specialty pharmaceutical company focused on innovative sustained-release drug delivery systems, today announced that its goserelin implant has received market authorization in one country each in the European Union and Central America. . AMW’s goserelin implant is the only generic implant version approved to date for AstraZeneca’s branded Zoladex®1. Goserelin enables symptomatic therapy of hormone-dependent tumors, such as prostate or breast cancer, as well as certain gynecological disorders. AMW’s goserelin implant is now available to patients in around 30 countries worldwide as a cost-effective alternative therapy.

AMW GmbH, a specialty pharmaceutical company focused on innovative sustained-release drug delivery systems, today announced that its goserelin implant has received market authorization in one country each in the European Union and Central America. AMW’s goserelin implant is the only generic implant version approved to date for AstraZeneca’s branded Zoladex®1. Goserelin enables symptomatic therapy of hormone-dependent tumors, such as prostate or breast cancer, as well as certain gynecological disorders. AMW’s goserelin implant is now available to patients in around 30 countries worldwide as a cost-effective alternative therapy.

AMW develops and produces innovative, bio-degradable 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 also receives royalties on licenses from its partners. To date, goserelin has been licensed to leading global and local pharmaceutical enterprises in more than 50 countries. In Germany, AMW’s products are distributed by the Company’s wholly owned subsidiary Endomedica GmbH.

“We are excited that, together with our distribution partners, we are now able to offer goserelin to a much higher number of patients in Europe and Central America,” commented Dr. Konstantin Petropoulos, CEO of AMW. “Access to generics or value added medicines of this drug class is still very limited, particularly in Europe. Together with our partners, we remain committed to making all our products widely available as improved and cost-effective alternative therapies. As a market leader for biodegradable sustained-release products, we expect further approvals of our products within the EU and beyond in the current year.”

About AMW:

AMW GmbH is a specialty pharmaceutical company focused on innovative bio-degradable sustained-release drug delivery systems. Products developed by AMW enable the administration of drugs via implants (subcutaneous) or patches (transdermal). The company was founded in 2008 and develops therapeutic solutions in oncology, neurology, dermatology, pain management, and ophthalmology. AMW currently has four marketed products (goserelin & leuprorelin implants, rivastigmine & buprenorphine patches).

AMW is based in Warngau, south of Munich.

About Goserelin:

Goserelin implant contains the active ingredient goserelin and belongs 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 hormonesensitive tumors such as prostate cancer or breast cancer with goserelin. In addition, goserelin 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.

For further information, please contact:

AMW GmbH

Dr. Konstantin Petropoulos

Tel.: +49 8024 470999-0

Email: news@a-m-w.eu

1Zoladex® is a trademark of Astra Zeneca UK Limited