Allergan, Inc.’s (AGN - Free Report) 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 the eye.
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 improvement than Roche’s (RHHBY - Free Report) 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.’s (VRX - Free Report) 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 term.
Allergan carries a Zacks Rank #2 (Buy). Investors can also consider stocks like Regeneron Pharmaceuticals, Inc. (REGN - Free Report) carrying a Zacks Rank #1 (Strong Buy).