Year Established: 2015
Revenues: $15,941 (+9%)
Loss: $4,404 (n/a)
R&D: $2,100 (-19%)
TOP SELLING DRUGS
|Botox Therapeutics||chronic migraine, overactive bladder||$1,375||16%|
|Linzess /Constella||irritable bowel syndrome||$723||13%|
|Alphagan/Combigan||glaucoma, ocular hypertension||$552||1%|
|Namenda XR||Alzheimer’s disease||$453||-28%|
While 2016 was the year of acquisitions for Allergan, this year has branded itself as the year of drug approvals from various agencies. The only major acquisition was that of Keller Medical, a privately held medical device company.
Although Allergan posted a solid 9% growth in reveneus in 2017, losses for the year include the impact of taxes paid in connection with the generic businesses sold to Teva Pharmaceuticals, and amortization of approximately $6.5 billion, primarily due to impairment charges recognized in 3Q17 of $3.2 billion related to Restasis and $646 million related to Aczone.
In terms of acceptances, notable highlights include the approval of Ozurdex by the CFDA for the treatment of adult patients with macular edema for retinal vein occlusion. This approval is key, as it is the first approved intravitreal injection for retinal vein occlusion in China, which is one of the most common causes of sudden, unilateral loss of vision. The FDA also accepted the NDA for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids.
In addition, November 2017 brought the FDA’s approval for the sNDA for Vraylar for the maintenance treatment of adults with schizophrenia. Vraylar is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.
Also, in February 2018 the FDA approved Avycaz for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This marks the third therapeutic indication for Avycaz, which was first approved in February 2015 for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and in 2017 for complicated urinary tract infections.
In aesthetics, the FDA approved BOTOX Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas: forehead lines, crow’s feet lines and glabellar lines.
Advancing through the pipeline, Allergan’s oral CGRP receptor antagonist Atogepant recently demonstrated promising efficacy and safety in episodic migraine prevention in a Phase IIb/III trial, meeting the primary endpoint across all doses with a statistically significant reduction in monthly migraine/probable migraine (MPM) headache days in patients with episodic migraine.