Allergan Reports First Quarter 2012 Operating Results
Product and Pipeline Update
During the first quarter of 2012:
- On January 18, 2012, Senju Pharmaceutical Co., Ltd received approval from the Japanese Ministry of Health, Labour and Welfare for AIPHAGAN® P Ophthalmic Solution 0.1% for the reduction of intraocular pressure in patients with ocular hypertension and/or glaucoma. Senju possesses the rights to develop and market AIPHAGAN® P within Japan.
- On March 12, 2012, Allergan confirmed that U.S. District Judge Andrew J. Guilford, after conducting a full trial, ruled that Merz Pharmaceuticals and Merz Aesthetics violated California’s Uniform Trade Secrets Act and issued a permanent injunction against them.
- On March 28, 2012, Allergan announced that two Phase III clinical trials of BOTOX® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Based on the results of the two Phase III clinical trials, Allergan submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX® as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.
Following the end of the first quarter of 2012:
- Allergan submitted an application with Health Canada seeking approval for the use of BOTOX® as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.
Outlook
For the full year of 2012, all expectations provided on February 2, 2012 remain unchanged. For the second quarter of 2012, Allergan expects:- Total product net sales between $1,450 million and $1,500 million.
- Non-GAAP diluted earnings per share attributable to stockholders between $1.04 and $1.06.
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