Actelion US Holdings Company, a subsidiary of Actelion Ltd, and Ceptaris Therapeutics, Inc. 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 U.S. Food and Drug Administration (FDA) approval of Ceptaris' product, VALCHLOR(TM).
If approved, VALCHLOR 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. VALCHLOR has a PDUFA date of 27 August 2013.
Under the terms of the Merger Agreement, Actelion paid to Ceptaris USD 25 million upon signing and will pay to Ceptaris' shareholders USD 225 million upon 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.
Jean-Paul Clozel, M.D. and Chief Executive of Actelion, commented: "Should the FDA approve VALCHLOR and Actelion acquire Ceptaris, we would be able to offer this meaningfully differentiated medicine to patients who today are dependent on formulations prepared locally by compounding pharmacies in a non-standardized environment. At the same time, we would leverage our existing knowhow and infrastructure in the fields of orphan and ultra-orphan indications when appropriately commercializing VALCHLOR to specialists in the field of dermatology and oncology."
Nicholas Franco, Chief Business Development Officer at Actelion commented: "If this transaction is consummated, we can build a product portfolio beyond our PAH franchise. We expect the transaction to become cash-accretive before the end of 2014."
"We believe that Actelion's expertise in rare diseases make it an ideal partner to deliver VALCHLOR to patients globally," said Stephen Tullman, President and CEO, Ceptaris Therapeutics, Inc. "We look forward to advancing VALCHLOR together to meet the needs of patients. We appreciate the ongoing support of our investors, led by Vivo Ventures (represented by Albert Cha), who have enabled us to develop VALCHLOR."