(Adds company comment from conference call, analyst comment;
updates share movement)
By Bill Berkrot
June 30 Allergan Inc said on Monday that
the U.S. Food and Drug Administration would not approve its
acute migraine aerosol treatment until certain concerns are
addressed, but the agency approved a new use for its implantable
eye drug, Ozurdex.
The Botox maker, which is fighting a hostile takeover bid by
Valeant Pharmaceuticals International Inc, said
Semprana, formerly known as Levadex, had received a second
"complete response letter" from the FDA delaying its approval.
Allergan now expects the agency's next action in the second
quarter of 2015.
Allergan shares were down 2.4 percent at $169.81.
In its letter, the FDA expressed concern about the delivery
device for the aerosol migraine medication, citing "content
uniformity on the improved canister filling process and on
standards for device actuation," Allergan said.
"We believe we may have existing data to answer FDA's
questions," Allergan research and development chief Scott
Whitcup told analysts on a conference call on its pipeline of
drugs in development.
"There is no scenario I can imagine under which we would not
take this forward," Whitcup said.
JPMorgan analyst Chris Schott called the Semprana delay a
modest negative, but added in a research note: "We expect the
company to respond to the FDA by year end and now believe we
could see an approval by the second quarter of 2015."
Allergan also announced plans to begin large Phase III
trials of its closely watched Darpin treatment for wet
age-related macular degeneration in the second quarter of 2015.
The company has cited the future sales potential of Darpin
and Valeant's lack of commitment to research and development as
one of its arguments for remaining independent.
"Valeant has neither the expertise nor the commitment to
maximize the value of Darpin," Allergan said in its pipeline
presentation on Monday.
Data from a small Phase II trial appears to suggest that
Darpin is at least as effective as Roche's Lucentis,
with a longer duration of activity.
Allergan said it believed Darpin could dry the retina more
quickly and effectively than current treatments, possibly
leading to superior vision improvement. The drug would also
compete with Regeneron Pharmaceutical Inc's Eylea.
Allergan said an improved manufacturing process could reduce
incidence of ocular inflammation seen in earlier Darpin trials.
But JPMorgan's Schott said: "Today's update does not change
our view that a potential combination with Valeant represents
the path to greatest value creation for both companies."
Ozurdex, Allergan's sustained-release biodegradable steroid
implant, received additional U.S. approval to treat diabetic
macular edema (DME) in adult patients who have an artificial
lens implant or are scheduled for cataract surgery.
Allergan said it hoped to receive European DME approval in
the second half of this year.
The drug was previously approved to treat macular edema and
non-infectious ocular inflammation.
(Additional reporting by Caroline Humer; Editing by Lisa Von