Qutenza is approved by the European Medicines Agency (EMA) for the treatment of peripheral neuropathic pain (PNP).
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.
Grünenthal CEO Gabriel Baertschi 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".
Astellas Pharma Europe operations president Yukio Matsui said: "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 pain.
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.