Actavis goes 1-for-2 with FDA as regulators knock blood pressure combo

Wednesday, it looked like Christmas had come early for Actavis ($ACT), with the FDA approving its new drug to treat dementia in Alzheimer's patients. But the Dublin drugmaker couldn't go two-for-two on the day, with the agency later striking down its high blood pressure cocktail.

U.S. regulators issued a complete response letter over the combo pill, which merges Actavis' Bystolic and Novartis ($NVS) giant Diovan. Now, the company will "review the complete response and determine the appropriate next steps," David Nicholson, SVP of Actavis' global brands R&D, said in a statement.

According to the pharma, the one-two punch hit its primary and secondary endpoints in a Phase III trial, posting statistically significant reductions in diastolic and systolic blood pressure at 8 weeks in hypertension patients. But in September, FDA staffers questioned whether the med could top the highest dose of one of its counterparts alone, voting 6-4 against recommending it for approval, Bloomberg notes.

It's a setback for Actavis, which has some lofty sales goals to hit in the wake of a buyout spree. This year alone, the company snatched up Forest Labs--which brought with it the Bystolic-Diovan combo--and Allergan ($AGN), vaulting itself into the ranks of Big Pharma's biggest. Along with the Allergan announcement came some eyebrow-raising top-line targets: Actavis has promised revenue growth of at least 8% a year, a high mark for a drugmaker of the new company's size.

But new FDA approval of Namzaric should help toward that end. After receiving the FDA's green light on Wednesday, Actavis said it expects to launch two dosage strengths of the therapy--which combines the active ingredient in Actavis' Namenda with that in Pfizer's ($PFE) Aricept--in the U.S. in Q2 of next year.

- read Actavis' releases here and here
- get more from Bloomberg

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