Completion of the acquisition 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. It was launched in the U.S. at the end of 2013 and sales have grown from $11 million in 2014 to $35 million globally in 2017. In the U.S., approximately 15,000 patients are currently diagnosed with stage IA-IB MF-CTCL, qualifying it as a rare or orphan disease.
The U.S. Food and Drug Administration 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.
The Group's U.S. subsidiary, Helsinn Therapeutics (U.S.), Inc., will draw on its extensive experience in cancer care products' sales to market Valchlor® in the U.S. and build upon the strong sales base it has already developed in the region.
The drug, known as Ledaga® in EU was approved by the European Commission in March 2017, for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma in adult patients for all stages and was granted orphan drug designation in 2012. In France, patients benefit from the drug under a temporary authorization for use ("Autorisation Temporaire Utilisation") program initiated during the second half of 2014.
Helsinn Group vice chairman and CEO Riccardo Braglia said: "Helsinn is delighted to announce the acquisition of Valchlor®/Ledaga®, for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed 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 U.S. where limited treatment choices are available.”
Source: Company Press Release