Lugano, Switzerland, 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, announced today the signing of an exclusive distribution license and supply agreement to register, distribute, promote, market and sell LEDAGA® (chlormethine gel) in Australia, Asia and the Middle East* as a topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (“MF-CTCL”) in adults.
Giorgio Calderari, Helsinn CEO commented: “I am pleased to announce this agreement with Juniper Biologics today which further widens the geographic distribution of LEDAGA®making this treatment option available to even more patients suffering from MF-CTCL. Juniper Biologics 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.
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 tumors 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.
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 almost 30 countries including Europe, Canada, Latin America.
For additional information please see the EU Summary of Product Characteristics.
Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and an innovative pipeline of cancer therapeutics.
Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners. Helsinn also has a fully integrated supply chain and product development through its subsidiary in Ireland, Helsinn Birex Pharmaceuticals Ltd.
Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.
To learn more about Helsinn please visit www.helsinn.com.
Backed by The Sylvan Group, Juniper Biologics is a science-led healthcare company focused on delivering novel therapies to improve the health and quality of life of patients, by building a growing presence in Oncology, Rare/Orphan Diseases and Gene Therapy. It was founded on a vision to provide treatments for unmet medical needs focused on specialist therapy areas in which it can make the most difference. Through bold and transformative science, Juniper Biologics is committed to creating possibilities that have the potential to become the next generation of lifechanging medicines for patient communities in China, Japan, Asia, Australia, New Zealand, Middle East and Africa.