Actelion bid for Ceptaris looks secured as FDA approves Valchlor

Privately-held USA-based Ceptaris Therapeutics revealed yesterday (August 26) that the US Food and Drug Administration has granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy.

Last month, Ceptaris signed an agreement to merge with US subsidiary of Swiss biotech firm Actelion (SIX: ATLN; The Pharma Letter August 1). The approval of Valchlor was a condition of closing the merger. Under the terms of the deal, Actelion paid Ceptaris $25 million on signing and will pay the US firm’s shareholders $225 million on closing of the transaction. Ceptaris' shareholders are also eligible to receive additional payments based on net sales of Valchlor and/or the achievement of certain commercial milestones. The companies are now completing further closing conditions before the acquisition is concluded.

First topical mechlorethamine approved by FDA