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Helsinn will acquire the global rights to Valchlor/Ledaga (mechlorethamine/chlormethine), a topical skin-cancer drug, from Actelion Pharmaceuticals.
On March 20, 2018, Helsinn, a Swiss pharmaceutical group, entered into a definitive agreement to acquire worldwide rights from Actelion Pharmaceuticals to Valchlor/Ledaga (mechlorethamine/chlormethine), an alkylating agent for the topical treatment of mycosis fungoidesâtype cutaneous Tâcell lymphoma (MF-CTCL). The transaction is subject to customary closing conditions and is expected to close in the second quarter of 2018.
Valchlor is the first and only FDA-approved topical formulation of mechlorethamine, according to the companies. It was launched in the United States at the end of 2013 and sales have grown from $11 million in 2014 to $35 million globally in 2017. FDA has granted the drug orphan drug designation. The company’s US subsidiary, Helsinn Therapeutics, will market Valchlor in the US.
In the European Union (EU), the same drug is marketed under the brand name Ledaga and was approved by the European Commission in March 2017 for treating MF-CTCL. It was granted orphan drug designation in the EU in 2012.
“Helsinn is delighted to announce the acquisition of Valchlor/Ledaga for the treatment of mycosis fungoides-type cutaneous Tâcell lymphoma in patients who have received prior skinâdirected therapy. This is a discomforting disease which has a significant impact on patients’ quality of life. Helsinn is committed to developing and marketing products designed to help people with cancer get the most out of every day and benefit from Valchlor, which is approved and marketed in the US where limited treatment choices are available. We are excited to be adding this drug to our portfolio of products designed to offer appropriate cancer therapeutic and supportive care treatment options to patients. We are looking forward to bringing the drug to more patients worldwide,” said Riccardo Braglia, Helsinn Group vice chairman and CEO, in a company press release.