License agreement signed allowing drug to treat mycosis fungoides to expand in Asia, Australia and the Middle East

September 1, 2022 - 3 minutes
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A license agreement has been signed between Helsinn Group and Juniper Biologics further widening the scope for distribution of T-cell lymphoma treatment, LEGADA.

The license signifies a supply agreement to register, distribute, promote, market and sell the drug in Australia, Asia and the Middle East as a topical treatment of the mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in adults.

Treatment option

Giorgio Calderari, Helsinn CEO said: “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.”

Approved: multiple countries

Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and the USA, 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.

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Raman Singh, CEO of Juniper Biologics added: “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.”

No curative treatments

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 with the median age at diagnosis being 55-60 years with male predominance. 

LEDAGA gel is an alkylating drug indicated for the topical treatment of MF-CTCL in adult patients. It’s 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.

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