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Actelion to buy Ceptaris

pharmafile | August 1, 2013 | News story | Sales and Marketing |  Actelion, FDA, ceptaris, valchlor 

The US arm of Swiss speciality pharma group Actelion is in line to pay $250 million to buy private firm Ceptaris Therapeutics – but the deal will only be sealed if the FDA approves a key product.

Actelion US Holdings Company will make the acquisition if Ceptaris’ Valchlor – a gel for the treatment of early-stage mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) – is given the green light by the US regulator, which is set to decide by the end of August.

The move comes against the backdrop of some challenging times for Actelion: last month it announced a cost saving plan which could see the loss of 260 jobs.

It has various problems: cost pressures from the strength of the Swiss Franc, increased competition in the US, and European pricing and reimbursement. 

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Actelion is banking on Valchlor, which would be the first such product for this rare cancer to gain US approval, to make up some of the financial ground that its lead brand – pulmonary hypertension treatment Tracleer – will lose as it edges towards patent expiry in 2015. 

Perhaps just as important, it allows the firm to expand its horizons. “If this transaction is consummated, we can build a product portfolio beyond our PAH franchise,” confirmed chief business development officer Nicholas Franco.

Mycosis fungoides is the most common type of CTCL, a form of non-Hodgkin’s lymphoma for which there is no cure, in which malignant T-cells in the body manifest themselves in the skin as lesions which may go on to form plaques and tumours.

Mechlorethamine, the active ingredient in Valchlor, has previously been approved for intravenous treatment of mycosis fungoides. Its approval in gel form would be more convenient to patients than the current treatment, which is put together by pharmacists.

“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-standardised environment,” explained Actelion chief executive Jean-Paul Clozel.

So far Actelion has paid $25 million to Ceptaris, with another $225 coming if the deal is closed – along with possible milestone and royalty payments.

“We believe that Actelion’s expertise in rare diseases make it an ideal partner to deliver Valchlor to patients globally,” said Ceptaris chief executive Stephen Tullman.

Actelion expects the transaction to become cash-accretive before the end of the year.

Adam Hill

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