On September 1, 2022 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and Juniper Biologics Pte Ltd, a science-led healthcare company focused on researching, developing and commercializing novel therapies, reported the signing of an exclusive distribution license and supply agreement to register, distribute, promote, market and sell LEDAGA (chlormethine gel) in Australia, Southeast Asia and the Middle East* as a topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma ("MF-CTCL") in adults (Press release, Juniper Biologics, SEP 1, 2022, View Source [SID1234618864]).
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Giorgio Calderari, Helsinn CEO commented: "I am pleased to announce this agreement with Juniper today which further widens the geographic distribution of LEDAGAmaking this treatment option available to even more patients suffering from MF-CTCL. Juniper is an excellent partner for Helsinn and I’m looking forward to working with them to deliver on our mission to improve the lives of people with cancer all over the world."
Raman Singh, CEO of Juniper Biologics stated: "This latest deal is testament of the shared purpose and strong partnership between Juniper Biologics and the Helsinn Group. The licensing of LEDAGA marks a key milestone in our mission to help improve the treatment for patients suffering from the burden of MF-CTCL. With LEDAGA, we will not only be adding to our growing portfolio of oncology medicines, we will more importantly be providing cancer patients with access to this important treatment option."
Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.
*The full list of countries covered by the license agreement includes: Australia, Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan, Brunei, Cambodia, Georgia, India, Indonesia, Iraq, Kazakhstan, Kyrgyzstan, Laos, Malaysia, Mongolia, Myanmar, Nepal, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Tajikistan, Turkmenistan, Uzbekistan and Vietnam.
About Mycosis Fungoides
Mycosis fungoides (MF) accounts for almost 50% of all primary cutaneous lymphomas, a form of non-Hodgkin’s lymphoma. The cause of MF remains unknown and there are no curative treatments. MF has an indolent clinical course, slowly progressing from patches to thicker plaques and eventually to tumours over years or decades. Signs include rash, patch and plaques with severe itch. MF typically affects older adults (median age at diagnosis: 55-60 years) with male predominance.
About LEDAGA
LEDAGA gel is an alkylating drug indicated for the topical treatment of MF-CTCL in adult patients. LEDAGA is a gel which is applied topically once a day. The drug has been approved by the European Commission (for the treatment of MF-CTCL in adult patients). Since June 2019, LEDAGA is commercialized in more than 30 countries including Europe, Canada, Latin America.