Allergan has slammed the brakes on two planned late-stage studies of a pair of key therapeutics in its pipeline, saying that investigators have to go back to the mid-stage drawing board in order to see whether their drugs work as hoped or whether a new formulation can salvage their efforts. And with profits slipping in the first quarter, the developer's ($AGN) stock price plunged 13% on Wednesday afternoon.
In a call with analysts, Chief Executive David Pyott said that "the data (on the vision-loss drug DARPin) "do not support directly moving to Phase III." Investigators now will regroup around a new mid-stage effort to determine safety and efficacy, with at least a one- to two-year delay for a program that was supposed to go into Phase III later this year. The disappointing data on that drug will be released at a scientific meeting in November.
The same dilemma confronted Allergan with its mid-stage data on Bimatopost, a hair-loss drug that had figured prominently in the company's late-stage planning. But the CEO says the data once again doesn't justify a move into Phase III, so investigators are going back to the clinic to test a new formulation at a 10-fold concentration alongside a novel formulation.
Allergan's loss was Regeneron's gain. Analysts say the setback will give Regeneron plenty more time to establish a blockbuster market for Eylea, a new drug for wet, age-related macular degeneration that is slated to earn about $1.25 billion this year.
"This gives Eylea even more time to become entrenched as the drug to beat," Adnan Butt, an analyst with RBC Capital Markets, tells Reuters.
Allergan officials also say they expect to return to the FDA later this year with a re-worked application for Levadex, a migraine drug Allergan acquired with MAP Pharmaceuticals. The agency had rejected the drug in April, citing manufacturing issues the biotech says it is already working on.
- here's the press release on the Q1
- read the Reuters report
- see the story from The Wall Street Journal