Allergan's Vraylar launch a success, despite trial failure
- Allergan on Monday hosted its first quarterly call since divesting its generics and Anda distribution businesses to Teva, giving investors a look at the company as a solely branded business.
- Along with earnings, Allergan announced that Vraylar, an antipsychotic partnered with Gideon Richter, failed to meet its primary endpoint in a major depressive disorder trial.
- Despite the trial failure in MDD, Vraylar is off to a strong start. The company just launched the drug in mid-March and gave details on other potential filings for the antipsychotic.
As Allergan works to be a “branded growth pharma” for the first time, the company is executing on a strong launch of its antipsychotic Vraylar (cariprazine), showing investors that it can function as a big pharma.
"2016 has been a year of tremendous positive transition for Allergan as we are well-positioned to continue to deliver strong results powered by our growth-pharma model," said CEO Brent Saunders on the August 8 call with investors.
"This model is built around five key elements: top line growth with the goal of double-digit growth; category leadership in each of our seven therapeutic areas; customer intimacy; open science R&D to fuel innovation; and operational excellence. And our team has been successfully executing on each of these elements," he added.
The growth-pharma model could be a lofty goal for the company, which has largely relied on its legacy generics business and growth-through-acquisition to gain traction. Now that it has divested its global generics business and its Anda distribution businesses to Teva, the company will have to rely more on its powerhouse drugs like Botox, which brought in a higher-than-expected $719 million during the second quarter.
Allergan has said it is not interested in a large acquisition at the moment and plans to use proceeds from the Teva sale to pay-down debt and buy back shares.
Along with partner Gideon Richter, Allergan launched Vraylar in mid-March for bipolar I disorder and schizophrenia.
"Interest by psychiatrist and select primary care physicians is very high. We've had multiple educational events where the attendance reached approximately 100 physicians. We're very encouraged by what we're seeing and hearing right now," said Chief Commercial Officer William Meury.
"Approximately 4000 psychiatrists have used Vraylar and we expect that number to climb to 10,000 by year-end. Based on solid performance so far we're expanding our sales force coverage of hospitals and mental health facilities.
However, Vraylar hit a setback on Friday, failing to show a separation from placebo in patients with major depressive disorder. This result is not unusual in psychiatric trials and the companies are likely to pursue further trials in MDD.
Allergan indicated that it will file for an expanded label of the drug in the first half of 2017, seeking an indication that shows the drug is effective in treating negative symptoms like social withdrawal and lack of emotional display.
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