Ceptaris wins FDA OK for lymphoma gel, clears path to $250M Actelion buyout

Malvern, PA-based Ceptaris Therapeutics nailed a delayed FDA approval for Valchlor, a drug designed for the most common form of cutaneous T-cell lymphoma. And the OK clears the way for Switzerland's Actelion ($ATLN) to go ahead with a deal to buy the company for $250 million.

Actelion paid $25 million down for its buyout pact just a few weeks ago, as Ceptaris was following up on a complete response letter from regulators issued in 2012. Vivo Ventures, Palo Alto Investors, Burrill & Co., Aperture Venture Partners, Osage, BioAdvance and new backer Third Point put together a $10 million D round to allow the company to respond to the CRL, which Ceptaris says centered on manufacturing concerns that have since been resolved.

Valchlor (mechlorethamine) is a topical, once-daily gel that can now be used for stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. Ceptaris says it is the first and only FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. Actelion has been pushing along applications for a new treatment--Opsumit (macitentan)--to replace its franchise drug for pulmonary arterial hypertension.

This buyout is structured to expand Actelion's pipeline beyond the lung disease PAH. Actelion said in a statement today that it is hammering out the final details of the buyout now that the FDA approval has come through.

The deal with Actelion fits into a successful biotech business model pursued by NeXeption, Ceptaris CEO and NeXeption Managing Partner Stephen Tullman tells FierceBiotech. NeXeption identifies product development opportunities, puts together the capital and management teams and then works to get the asset ready for a buyout deal.

In this particular case some VCs Tullman was familiar with came by looking for a set of expertise to "run the last leg of the relay. They asked us to take it on." And the deal with Actelion--which has to be cleared now by regulators to move to completion in the next few weeks--followed. NeXeption's team put together the $21 million round last fall to back Aclaris Therapeutics and Tullman helped arrange Cephalon's $250 million buyout of Ception Therapeutics following a Phase II study as well as Allergan's deal to buy Vicept Therapeutics in a $275 million deal.

"I'm proud of the team," says Tullman. The plan now is to help smooth the transition for Actelion and then move on to a new project with venture backers.

"This is good news for patients and the treatment community," said Stanford Professor Youn H. Kim. "We now have the confidence of a FDA-approved product backed by evidence from a well-controlled clinical trial that demonstrated clinically meaningful responses in the majority of patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) who have received prior skin-directed therapy."

- here's the press release