Actelion has completed its purchase of Ceptaris Therapeutics following the approval last month of the latter’s lymphoma gel product Valchlor.
Actelion’s interest in privately-held Ceptaris was first revealed at the end of July, when it said it was offering $250m for the company provided the FDA gave a green light to Valchlor (mechlorethamine hydrochloride) as a treatment for patients with early-stage mycosis fungoides-type cutaneous T-cell lymphoma (CTL).
The approval of Valchlor for the most common form of CTL was delayed while the FDA asked for more data on the dossier last year, specifically focusing on issues related to the manufacturing processes for the topical gel product.
While mechloroethamine (also known as nitrogen mustard) treatment has been used in CTL patients for years, Ceptaris’ formulation is the first standardised product to reach the US market.
Previously “patients were dependent on formulations prepared locally by compounding pharmacies in a non-standardised environment,” according to Actelion’s chief executive Jean-Paul Clozel. “Such preparations do not undergo the same rigorous FDA review as Valchlor,” he added.
Switzerland-based Actelion believes the drug will meet a significant unmet demand when it makes its debut on the US market in the fourth quarter of 2013. The drug is also under review in the EU as an orphan drug.
For Actelion the deal is significant as Valchlor is the first cancer product in its portfolio, which to date has focused on pulmonary arterial hypertension (PAH) with products such as Tracleer (bosentan) and Veletri (epoprostenol).
The move into oncology accompanies an expansion of Actelion’s portfolio into speciality areas such as Gaucher disease, with its already-marketed Zavesca product (miglustat), and also drug-resistant infections with its antibiotic candidate cadazolid which is in phase III testing.
The diversification has come at a time when Actelion’s dramatic growth in revenues and profits started to stall on the back of increased competition in the PAH sector.