Actelion is granted marketing authorization by the European Commission for Ledaga (chlormethine gel) for the treatment of MF-CTCL

Actelion Pharmaceuticals Ltd / Actelion is granted marketing authorization by the European Commission for Ledaga (chlormethine gel) for the treatment of MF-CTCL . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL/BASEL, SWITZERLAND - 07 March 2017 - Actelion Ltd (SIX: ATLN) announced today that the European Commission has granted marketing authorization for the use of Ledaga^® (chlormethine gel) 160 micrograms/g for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).

MF-CTCL is a rare, potentially life-threatening immune system cancer that is chronic and usually progresses slowly. The course of disease in individual patients is unpredictable. In about 34% of cases, a progression of the disease is observed, and in the most advanced stages, MF-CTCL cells can metastasize to other body tissues, including the liver, spleen and lungs.

Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF type CTCL) in adult patients.

The market authorization for Ledaga is based on the results of the pivotal 201 study, the largest randomized controlled study ever conducted in early stage MF-CTCL, involving 260 patients. In this study, within the efficacy evaluable (EE) population, 77% of patients who were treated for at least 6 months with chlormethine gel achieved a clinical response in the Composite Assessment of Index Lesion Severity (CAILS) score, while 59% of those treated with the compounded control had a clinical response. A response was defined as at least a 50% improvement in the baseline CAILS score. Complete response was achieved in 19% of patients treated with chlormethine gel in the EE population versus 15% of patients treated with the compounded control. Reductions in mean CAILS scores were seen as early as four weeks into the study, with further reductions observed with continuing therapy.

In the 201 study, the most frequent adverse reactions reported with chlormethine gel were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%). No evidence of systemic absorption of chlormethine was observed with the treatment.