Mergers and Acquisitions

* On August 26, 2013, Actelion has announced that the FDA has granted marketing approval for Valchor™ (mechlorethamine) Gel 0.016% 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. One of the closing conditions of Ceptaris's acquisition includes the FDA approval of Valchor™. The companies are now completing further closing conditions before the acquisition is concluded. Actelion will provide a further update upon closing.
* On July 31, 2013, Actelion US Holdings Company, a subsidiary of Actelion, and Ceptaris Therapeutics have announced that they have entered into an agreement for Actelion to acquire Ceptaris.  Under the terms of the Agreement, the merger is contingent upon certain closing conditions, including FDA approval of Ceptaris' product, Valchor™. If approved, Valchor™ would be the first and only FDA-approved topical formulation of mechlorethamine for the treatment of early-stage mycosis fungoides-type cutaneous T-cell lymphoma. Valchor™has a PDUFA date of 27 August 2013.

Under the terms of the merger agreement, Actelion paid to Ceptaris $ 25 million upon signing and will pay to Ceptaris' shareholders $ 225 million upon closing of the transaction. Ceptaris' shareholders are also eligible to receive additional payments based on net sales of Valchor™ and/or the achievement of certain commercial milestones.

Mechlorethamine is a chemotherapeutic agent previously approved for intravenous treatment of mycosis fungoides, the most common type of CTCL. Topical mechlorethamine preparations are currently recommended for the treatment of early stage CTCL by the National Comprehensive Cancer Network (NCCN). However, there are no FDA-approved topical mechlorethamine products, limiting availability to non-standardized, pharmacy-compounded preparations.