Per the terms of the merger agreement, Actelion paidCeptaris $25 million upon signing, with an additional $225 million to be paidto Ceptaris' shareholders once the transaction has closed. In addition,Ceptaris' shareholders are also eligible to receive additional payments basedon the achievement of certain commercial milestones and/or net sales ofVALCHLOR, Ceptaris' product candidate for the treatment of mycosis fungoides,the most common type of cutaneous T-cell lymphoma. The merger is dependent uponcertain closing conditions, which includes approval of VALCHLOR by the U.S.Food and Drug Administration (FDA). The product candidate has a PDUFA date ofAugust 27.
"We believe that Actelion's expertise in rare diseases makeit an ideal partner to deliver VALCHLOR to patients globally," said StephenTullman, president and CEO of Ceptaris, in a press release regarding thetransaction. "We look forward to advancing VALCHLOR together to meet the needsof patients. We appreciate the ongoing support of our investors, led by VivoVentures (represented by Albert Cha), who have enabled us to develop VALCHLOR."
If VALCHLOR gains FDA approval, it would be the first andonly topical formulation of mechlorethamine for the treatment of early-stagemycosis fungoides-type cutaneous T-cell lymphoma. This condition is a rare formof non-Hodgkin's lymphoma, and there is no known cure. In a multi-centerclinical study of Ceptaris' mechlorethamine gel, in patients with early-stagemycosis fungoides, the gel met its primary endpoint of an assessment of lesionseverity, as well as its secondary endpoint. Adverse events included dermatitisand hyperpigmentation, with the former ranging from mild to moderately severe.The gel was granted both Fast Track status and orphan drug status by the FDA.
"Should the FDA approve VALCHLOR and Actelion acquireCeptaris, we would be able to offer this meaningfully differentiated medicineto patients who today are dependent on formulations prepared locally bycompounding pharmacies in a non-standardized environment," Jean-Paul Clozel,M.D., chief executive of Actelion, commented in a statement. "At the same time,we would leverage our existing know-how and infrastructure in the fields oforphan and ultra-orphan indications when appropriately commercializing VALCHLORto specialists in the field of dermatology and oncology."
"If this transaction is consummated, we can build a productportfolio beyond our PAH franchise," Nicholas Franco, chief businessdevelopment officer at Actelion, said in a press release. "We expect thetransaction to become cash-accretive before the end of 2014."