* Drug is first such immunotherapy pill licensed in U.S.
* Merck and partner ALK Abello expected to launch rival drug
* Shares in Stallergenes rise 6 percent
(Adds detail, share price, analyst comment)
CHICAGO/PARIS, April 2, France's Stallergenes
has received U.S. regulatory approval to sell the
first immunotherapy pill against grass allergies in the world's
biggest pharmaceutical market, sending its shares up 6 percent
Stallergenes has said it sees a potential U.S. market of
nearly 3 million patients that will eventually be worth $1
billion in annual sales for these types of drugs.
"That's very positive news as the group is considerably
expanding its market," Gilbert Dupont analysts wrote in a note.
Oralair is a fast-dissolving tablet to be placed under the
tongue that contains extracts from five types of grass pollen:
sweet vernal, orchard, perennial rye, timothy and Kentucky
bluegrass. It harnesses the immune system to alleviate allergies
and is an alternative to current treatments that need to be
Merck and Danish partner ALK Abello are
also expected to launch their rival therapy Grastek in the
United States this year. In December, both drugs received strong
recommendations from outside advisers to the U.S. Food and Drug
Oralair was approved in the European Union in 2008 and is
also sold in Canada, Australia and Russia for the treatment of
grass pollen allergy. It generated revenue of 22.2 million euros
($30.5 million) in 2013, up 37 percent from 2012.
Greer Laboratories, Stallergenes' U.S. partner, aims to
begin selling Oralair within weeks of the FDA's go-ahead. But
the peak season for Oralair prescriptions is between December
and June, so U.S. revenue from the drug this year should be
limited, Stallergenes' former chief executive said last
The approval of Oralair triggers a first milestone payment
of $10 million from Greer to Stallergenes. Overall, Stallergenes
is due to receive milestone payments totaling up to $120
million, plus royalties and an undisclosed transfer price.
Shares in Stallergenes were 6 percent higher at 61.49 euros
at 0840 GMT, trading at more than twice their average daily
volume and giving the company a market capitalisation of 843
($1 = 0.7271 Euros)
(Reporting by Susan Kelly in Chicago and Natalie Huet in Paris;
Editing by Eric Walsh and James Regan)