allergan plc (AGN) Key Developments
Allergan plc Recalls in the U.S. of Specific Lots of REFRESH Lacri-Lube, REFRESH P.M., FML (Fluorometholone Ophthalmic Ointment) 0.1%, and Blephamide(Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment, USP) 10%/0.2% for Particulate Matter
Aug 24 15
Allergan plc announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH Lacri-Lube 3.5g and 7g for dry eye, REFRESH P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. The company chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action from unscrewing the cap of the aluminum tube, and potentially introduced into the product. Reported adverse events include Foreign Body in Eye (12), Eye Irritation (2), Ocular Discomfort (2), Product Contamination (2), Superficial Injury of Eye (2), Eye Pain (1), Eye Swelling (1) and Vision Blurred (1). The company has informed the U.S. Food and Drug Administration of this voluntary recall. The recall only applies to specific lots of the REFRESH Lacri-Lube, REFRESH P.M., FML (fluorometholone ophthalmic ointment) 0.1%, Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%. This recall does not affect any other REFRESH or Allergan product.
U.S. Food and Drug Administration Accepts Allergan plc's BOTOX (onabotulinumtoxinA) Resubmission for the Treatment of Lower Limb Spasticity in Adults
Aug 20 15
Allergan plc announced that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its Supplemental Biologics License Application (sBLA) for BOTOX (onabotulinumtoxinA) for the treatment of adults with lower limb (involving ankle and toe muscles) spasticity in adults. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act (PDUFA) date is expected to be in the first quarter of 2016. The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity. In April 2015, the FDA approved an expansion of the BOTOX (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units for the treatment of upper limb spasticity. The FDA also approved an increase to the maximum BOTOX cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
Allergan Files ANDA with FDA Seeking Approval to Market Posaconazole Delayed-Release Tablets, 100Mg; Merck Sharp & Dohme Corp. Files Suit Against Allergan Seeking to Prevent Allergan from Commercializing its Anda Product Prior to the Expiration of U.S. Patent No. 5,661,151
Aug 11 15
Allergan plc confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Posaconazole Delayed-Release Tablets, 100mg. Allergan's ANDA product is a generic version of Merck's Noxafil which is an antifungal agent indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high-risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplantation recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
Merck Sharp & Dohme Corp. filed suit against Allergan on August 6, 2015 in the U.S. District Court for the District of New Jersey seeking to prevent Allergan from commercializing its ANDA product prior to the expiration of U.S. Patent No. 5,661,151. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan's ANDA for up to 30 months from the date the plaintiffs received notice of Allergan's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Allergan plc Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015
Aug 6 15
Allergan plc reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company’s net revenues were $5,755.0 million against $2,667.2 million a year ago. Operating loss was $162.9 million against operating income of $206.1 million a year ago. Loss before income taxes and non-controlling interest was $548.9 million against income before income taxes and non-controlling interest of $92.4 million a year ago. Net loss attributable to ordinary shareholders was $312.7 million or $0.80 per basic and diluted share against net income attributable to ordinary shareholders of $48.7 million or $0.28 per basic and diluted share a year ago. Net cash provided by operating activities was $1,401.3 million against $469.5 million a year ago. Additions to property, plant and equipment were $111.6 million against $38.3 million a year ago. Non-GAAP net income attributable to ordinary shareholders was $1,827.6 million or $4.41 diluted per share against $598.2 million or $3.42 diluted per share a year ago. EBITDA was $1,535.7 million against $642.6 million a year ago. Adjusted EBITDA was $2,613.0 million against $862.0 million a year ago. On a non-GAAP basis, consolidated net revenue for the second quarter was $5.7 billion, an increase of 36% versus first quarter of 2015.
For the six months, the company’s net revenues were $9,989.2 million against $5,322.3 million a year ago. Operating loss was $484.8 million against operating income of $414.0 million a year ago. Loss before income taxes and non-controlling interest was $1,238.9 million against income before income taxes and non-controlling interest of $233.5 million a year ago. Net income attributable to ordinary shareholders was $755.1 million or $2.48 per basic and diluted share against net income attributable to ordinary shareholders of $145.2 million or $0.83 per basic and diluted share a year ago. Net cash provided by operating activities was $1,926.3 million against $909.1 million a year ago. Additions to property, plant and equipment were $248.2 million against $80.8 million a year ago. Non-GAAP net income attributable to ordinary shareholders was $3,110.1 million or $8.71 diluted per share against $1,209.1 million or $6.91 diluted per share a year ago. EBITDA was $1,998.7 million against $1,335.1 million a year ago. Adjusted EBITDA was $4,395.1 million against $1,722.2 million a year ago.
FDA Approves 28 Additional Styles Of Allergan's Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
Aug 5 15
Allergan plc announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market 28 additional styles of Natrelle® 410 silicone-filled breast implants, giving surgeons and patients more options to achieve desired outcomes. The FDA approved extra-full projection styles (X), along with additional low projection, low height styles (L) from the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant line, for use in breast reconstruction, augmentation and revision surgery. Designed to mirror the shape of a woman's breast, the Natrelle® 410 Shaped Gel Breast Implants are filled with a highly cohesive silicone gel which enables the implants to have long-lasting shape over time. The additional projection styles offer surgeons more options to better meet the individual needs of each patient.