12/12/2016

Aachen, December 12, 2016. Grünenthal Group today announced that it has entered into a definitive agreement with Astellas Pharma Europe Ltd., (“Astellas Pharma Europe”), the European subsidiary of Tokyo-based Astellas Pharma Inc. (“Astellas”), for the exclusive rights to the dermal patch Qutenza® (capsaicin 8%) in Europe, Middle East and Africa. Qutenza® is approved by the European Medicines Agency (EMA) for the treatment of peripheral neuropathic pain (PNP).

Grünenthal adds Qutenza^® to its portfolio to bring benefit to patients by widening treatment options in neuropathic pain

Grünenthal will hold exclusive rights for Qutenza® in all 28 European Union member states, Switzerland, Iceland, Norway and Lichtenstein, and other East European, Middle East and African countries.

The high-dose capsaicin (8%) containing dermal patch Qutenza® (Rx) was developed by NeurogesX and licensed to Astellas Pharma Europe in 2009. The original EMA approval for Qutenza® was obtained in 2009 for the treatment of peripheral neuropathic pain excluding diabetic polyneuropathy (DPN). Following a label extension in 2015, DPN is now included, thus broadening the Qutenza® label to all peripheral neuropathic pain subgroups.

Grünenthal, a privately owned mid-cap pharmaceutical company is a recognized specialist in pain and offers a wide range of products and support for physicians and patients. Gabriel Baertschi, CEO Grünenthal said: “We have a clear strategy to further build our pain portfolio through in-house innovation and external acquisition. Adding Qutenza® is a perfect strategic fit and will broaden the options available to physicians, especially in localized neuropathic pain – an area of remaining high unmet need for patients."

Dott. Alberto Grua, member of the Corporate Executive Board, CCO Europe, North America and Global Operations at Grünenthal added: “Grünenthal is one of the leading companies in the field of pain in Europe. With our products we have built up a high level of expertise in neuropathic pain which will allow us to market Qutenza® successfully”.

Yukio Matsui, President of Operations, Astellas Pharma Europe commented, “This agreement is a part of our work toward higher quality and efficiency of operations through optimisation of resources and will ultimately provide hope for more patients around the world. Grünenthal has a long track record in pain and will be well placed to provide Qutenza® to more patients who stand to benefit. We are looking forward to working closely with Grünenthal to ensure smooth continuation of product supply.”

About Qutenza® (capsaicin 8% patch)

The capsaicin 8% patch which was developed by NeurogesX and licensed to Astellas Pharma Europe in 2009 is approved by the European Medicines Agency for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain¹. The capsaicin 8% patch is currently approved for use in 27 countries across Europe. The capsaicin 8% patch delivers a high-dose of capsaicin directly to the damaged nerves in the skin that are the source of neuropathic pain. Applied to the area of pain, the capsaicin reduces their spontaneous activity and consequently reduces the neuropathic pain intensity. Important information for the capsaicin 8% patch, including safety information, is included in the full Summary of Product Characteristics at: https://www.medicines.org.uk/emc/medicine/23156

References:

^1. European Medicines Agency (2015). European Public Assessment Report for Qutenza® (capsaicin). Available at : http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000909/human_med_001008.jsp&mid=WC0b01ac058001d124 . Accessed 8 November 2016

• Grünenthal to acquire commercialization rights of Qutenza® in Europe from Astellas Pharma Europe  (pdf, 294 KB)