After Allergan plc's recent restructuring to soften the blow from incoming drug competition, the drugmaker's progress with an experimental migraine medicine was a focus of the company's fourth-quarter 2017 earnings call.
The Dublin-based company cut 1,000 jobs after efforts to stave off competition for dry eye medicine Restasis failed. It expects rivals for the therapy as early as this April, as generic-drug maker Mylan NV has already shared plans to file.
Allergan's migraine pill, ubrogepant, is one of a new class of drugs that includes injectable contenders from Eli Lilly and Co. and Teva Pharmaceutical Industries Ltd. Just ahead of fourth-quarter results, Allergan released phase 3 data its own medicine in acute settings — or use during episodes, rather than preventatively — with a significant portion of patients reporting no pain two hours after taking the drug.
The company expects more late-stage data for ubrogepant in the first half and plans to file for U.S. approval in 2019.
Yet positive data aside, it is unlikely that sales will take off before late 2019, according to Executive Vice President and Chief Commercial Officer William Meury. The drug will be paid for by both commercial health plans and Medicare Part D, he said, which use formularies, or lists of covered drugs, that are constructed annually. While there can be changes to formularies at different parts of the year, extensive lists for the next year are typically issued in the late summer.
"I don't want to speak for Amgen Inc., Novartis AG and Teva, or Lilly and Alder Biopharmaceuticals Inc.," Meury said, referring to Allergan's migraine rivals and their potential launch plans. "I don't think there's a fast ramp for many products, to be fair, in the industry anymore."
Many of the other migraine drugmakers are aiming for preventive use, curbing the number of headaches a month rather than offsetting pain once they begin, as ubrogepant does. In this arena, Allergan hopes that Botox can stave off competition.
"We expect Botox will maintain a dominant position in the chronic migraine market with the CGRPs garnering more use in frequent episodic," Meury said.
Botox's therapeutic sales — or medical uses, such as for headaches, skincare and overactive bladder — rose just over 17% in the last quarter of 2017, making $367.2 million.
The multipurpose toxin also maintained its popularity as an anti-wrinkle treatment: Cosmetic sales grew 14.5% over the same period in 2016, hitting $228 million in the fourth quarter. In total, it made more than $2.2 billion over the year, a 13.7% boost on 2016 sales.
Botox's many uses are a key reason for the company to keep its medical and aesthetics arms together, Chairman, President and CEO Brent Saunders said during the JPMorgan Healthcare conference in January.
The aesthetics business continues to be a consistent growth driver, according to executives on the call. As millennial beauty trends shift to volume and contouring, Allergan's facial filler Juvéderm hit blockbuster status in the year, achieving $1 billion globally and setting up to rival Botox's sales strength in coming years, according to Meury.
The company also recently launched a direct-to-consumer advertising campaign for CoolSculpting, a weight loss and shaping treatment it acquired in 2017 for $2.47 billion.
It is also focusing on Vraylar, a schizophrenia and bipolar mania drug in an ongoing late-stage study for bipolar depression, which could expand its potential by $500 million a year, Meury said.
