Helsinn to acquire worldwide rights to Valchlor/Ledaga

Swiss oncology specialist Helsinn Pharmaceuticals has entered into a definitive agreement to acquire worldwide rights to Valchlor/Ledaga, (mechlorethamine/chlormethine), an alkylating agent for the topical treatment of mycosis fungoides‐type cutaneous T‐cell lymphoma (MF-CTCL), from Actelion Pharmaceuticals, a Swiss biotech firm which was acquired by US health care giant Johnson & Johnson (NYSE: JNJ) under a $30 billion deal last year.

Completion of the acquisition is subject to customary closing conditions, and is expected to close in the second quarter of 2018. Terms of the acquisition are not being disclosed.

Valchlor is the first and only US Food and Drug Administration-approved topical formulation of mechlorethamine. It was launched in the USA at the end of 2013 and sales have grown from $11 million in 2014 to $35 million globally in 2017. In the USA, around 15,000 patients are currently diagnosed with stage IA-IB MF-CTCL, qualifying it as a rare or orphan disease. The US FDA has granted it orphan drug designation. To date, limited treatment choices are available for those patients who can benefit from Valchlor through the reimbursement by a wide range of public and commercial payers.