) shares slipped 2.72% after the company announced that it has
received a complete response letter (CRL) from the FDA for its
migraine candidate Semprana (formerly known as Levadex). Allergan
is looking to get Semprana approved as an acute treatment of
migraine in adults.
We note that the FDA did not raise any issues related to the safety
and efficacy of Semprana in the CRL. The two issues mentioned in
the CRL were related to specifications about content uniformity on
the improved canister filling process and standards for device
actuation. Allergan plans to meet with the FDA to resolve these
issues and resubmit the marketing application for Semprana. The
company expects the FDA to review and render a decision on the
candidate by the end of the second quarter of 2015.
Meanwhile, all is not gloomy at Allergan. The FDA has approved its
drug, Ozurdex, for the treatment of adults suffering from diabetic
macular edema (DME) who have an artificial lens implant
(pseudophakic) or who are scheduled for cataract surgery (phakic).
We are positive on Ozurdex's label expansion. Ozurdex was already
approved for swelling of the macula after branch retinal vein
occlusion or central retinal vein occlusion and noninfectious
inflammation of the uvea (uveitis) affecting the back segment of
Allergan also provided an update on a few of its pipeline
candidates. The company discussed its plans to initiate phase III
studies on bimatoprost sustained-release implant for the treatment
of elevated intraocular pressure and glaucoma by the end of 2014.
Allergan also announced plans to start phase III trials on abicipar
pegol for wet age-related macular degeneration in the second
quarter of 2015. In stage 3, a phase II study revealed that the use
of abicipar pegol led to an equal or even better visual acuity
) Lucentis. Additionally, abicipar pegol is more convenient to use
as it requires less frequent injections.
Valeant Takeover Attempts
Last week, Allergan once again rejected
Valeant Pharmaceuticals International, Inc.
) acquisition offer. Valeant's exchange offer comprised $72.00 in
cash and 0.83 Valeant shares per Allergan share held, representing
a value of $173.20 per share of Allergan. We expect investor focus
to remain on the Valeant-Allergan takeover updates in the near
Allergan carries a Zacks Rank #2 (Buy). Investors can also consider
Regeneron Pharmaceuticals, Inc.
) carrying a Zacks Rank #1 (Strong Buy).
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