FDA Approves Valeant's Latest Acne Treatment

Valeant announced that it has received FDA approval for its Onexton gel, indicated for the treatment of acne vulgaris. This approval is the latest in a series of moves that reinforces Valeant’s focus on ophthalmology and dermatology.

Onexton is a once-a-day topical treatment for both inflammatory and non-inflammatory acne in patients aged 12 and older. Clinical trials found that it was consistently well-tolerated, and efficacy was assessed after week 12 of use.

Michael Pearson, CEO of Valeant, reported that Onexton was the company’s fourth dermatological treatment to receive FDA approval in the last twelve months. The projected 2015 launch of Onexton follows the launch of anti-fungals Jublia and Luzu, and Retin-A Micro, another acne medication.

Acne vulgaris affects between 40 and 50 million Americans of all ages. The American Academy of Dermatology estimates that nearly 85 percent of people have had acne at some point in their lives and that acne treatment represents a $2.2 billion industry.

After Valeant’s 2013 acquisition of Bausch & Lomb (B&L) for $8.6 billion, Pearson expressed his interest in both dermatology and eye care. He remarked to Bloomberg then that dermatology, like eye-care, was a “growing market, a growing specialty.”

The past few years have seen Valeant pursue an aggressive line of acquisitions which target dermatology, notably Janssen Pharma, Medicis, Obagi Medical, a failed acquisition of Cephalon to Teva Pharma and most recently, the failed acquisition of Allergan, which recently tied the knot with Actavis to avoid Valeant’s hostile bid for ownership.

Pearson’s strategy since taking over as CEO of Valeant in 2008 has been strategic acquisitions, but he expressed in the Onexton press release Valeant’s renewed commitment to R&D growth as well.