March 5, 2014 / 7:07 PM / 4 years ago

UPDATE 1-Stallergenes appoints former Actelion manager as new CEO

* Christian Chavy to succeed Roberto Gradnik on March 31

* Gradnik says decision is down to “new cycle” for the company

* Stallergenes eyes FDA nod for Oralair this month

* 2013 revenues up 3.5 pct, driven by Oralair

* Company eyes further acquisitions this year - Gradnik

By Natalie Huet and Noëlle Mennella

PARIS, March 5 (Reuters) - France’s Stallergenes said on Wednesday it had appointed former Actelion manager Christian Chavy as its new chief executive to drive the company’s expansion into the U.S. immunotherapy market.

Stallergenes is hoping to win by the end of the month a U.S. green light to launch its immunotherapy pill Oralair for the treatment of grass allergies.

Chavy, 65, will become CEO as of March 31, replacing Roberto Gradnik, 57, the company said in a statement. Chavy, who was already on Stallergenes’ board and strategic committee, previously worked for healthcare investment fund ARES Life Science, and as president of global operations for Actelion, Europe’s biggest biotech company.

Gradnik, who has headed Stallergenes for the past two-and-a half years, told Reuters Chavy would take over because the new man had the international experience needed to steer the company in this new phase. Gradnik also stressed he would help ensure a smooth transition as a consultant for the company for four months.

“We’re very close to getting a response from the FDA for Oralair in the United States. We’re closing a very important cycle of transformation for the company and it’s good, for the next cycle, to bring in some change,” he said in a telephone interview.

Currently marketed in 22 countries, Oralair is a fast-dissolving tablet to be placed under the tongue that contains extracts from five grass pollens - Sweet vernal, Orchard, Perennial rye, Timothy, and Kentucky bluegrass. It harnesses the immune system to alleviate allergies and is an alternative to current injectable treatments.

Merck and Danish partner ALK Abello are expected to launch their own drug Grastek in the United States in about the same time frame as Stallergenes.

Also on Wednesday, Stallergenes posted a 3.5 percent rise in revenue in 2013, to 248.1 million euros ($340.8 million), driven by a 37 percent jump in sales of Oralair.

Earnings before interest, tax, depreciation and amortisation (EBITDA) rose 2.8 percent to 71.3 million euros and represented 29.2 percent of revenues, an increase from 28.9 percent in 2012.

For 2014, the company said it would target low single digit growth in revenues and an EBITDA margin of at least 25 percent, assuming European state social security systems maintain stable reimbursement conditions.

This guidance does not factor in a U.S. launch of Oralair, Gradnik stressed, noting the impact was difficult to predict.

Greer Laboratories, Stallergenes’ US partner, aims to begin selling Oralair within weeks of the Food and Drug Administration’s go-ahead. But the peak season for Oralair prescription is between December and June, and with an FDA decision due at the end of March, U.S. revenue on the drug for the spring season would be “very limited”, Gradnik said.

Stallergenes had roughly 109 million euros of cash at the end of 2013 and Gradnik said the company would use it to buy companies in regions where it seeks to expand - notably Latin America and Asia - and technologies complementing its internal research and development.

Shares in Stallergenes closed down 1.36 percent at 53.65 euros before the announcements, giving the company a market capitalisation of about 735 million euros.

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