Allergan, Inc. announced that its wholly-owned subsidiary, Allergan Sales, LLC, has entered into an agreement with QLT USA, Inc., a wholly-owned subsidiary of QLT Inc., to acquire QLT's Aczone (dapsone) gel 5 per cent product, a topical treatment for acne vulgaris.
Aczone gel 5 per cent is indicated in the United States and Canada for the treatment of acne vulgaris in patients 12 years and older. In two randomized, double-blind, vehicle controlled clinical studies involving approximately 3,000 patients, Aczone gel 5 per cent achieved a statistically significant reduction in the number of acne lesions and a better success rate relative to vehicle use alone on the Global Acne Assessment Score, a 5-point scale designed to assess the severity of facial acne vulgaris ranging from no or minimal to significant acne lesions. Aczone gel 5 per cent is the only acne treatment harnessing dapsone in a topical formulation to provide patients with a convenient and effective therapy.
"Aczone gel 5 per cent is the first new chemical entity approved by the FDA for the treatment of acne in several years, and represents an important clinical advance in dermatology with a robust safety and efficacy profile demonstrated in more than 3,000 patients," said Scott Whitcup, MD, Allergan's executive vice president of research and development. "We are excited to make Aczone gel 5 per cent widely available to dermatologists and their patients in North America, underscoring our commitment to continue to invest and respond to unmet medical needs in dermatologic therapies and building upon our more than 10 years of success with Tazorac".
Allergan expects to launch Aczone gel 5 per cent in the fourth quarter of 2008 to dermatologists in the United States and Canada.
Under the terms of the agreement, Allergan will pay approximately $150 million for all assets relating to Aczone gel 5 per cent upon closing, which is expected to occur in the third quarter of 2008. Closing of the transaction is subject to antitrust clearance under the Hart-Scott-Rodino Act and other customary closing conditions. Allergan estimates that Aczone Gel 5 per cent could reach peak year revenue in excess of $75 million. Allergan anticipates the transaction will not be dilutive in 2008. About Acne
Acne vulgaris, or acne, is a common skin disorder with an estimated 80 percent of all people between the ages of 11 and 30 years old experiencing outbreaks at some point.
Aczone gel is an aqueous topical gel formulation containing 5 per cent dapsone developed by QLT, Inc.'s wholly-owned subsidiary, QLT USA, Inc., for the treatment of acne vulgaris. Combining dapsone in a Solvent Microparticulate gel enables dapsone to be applied topically and safely.