Valeant Pharmaceuticals International, Inc. announced that its subsidiary, Biovail Laboratories International SRL has entered into an agreement to license the Canadian rights to Aczone (dapsone) gel 5%, a topical formulation of dapsone used in the treatment of acne vulgaris, from Allergan. Allergan will receive from BLS a CA$500,000 upfront payment to be followed by subsequent additional payments based on net sales.
“Aczone gel is a strong addition to our Canadian business,” said J Michael Pearson, chief executive officer. “This compound was originally approved in 2006 and never launched into the Canadian marketplace, providing Valeant Canada with a unique opportunity to strengthen and enhance our dermatology portfolio in Canada.”
Aczone gel is used to treat acne in patients 12 years of age and older. Acne is a skin condition characterized by the development of whiteheads, blackheads and other types of pimples. While acne can affect patients of any age, the condition is especially prevalent during adolescence.
Aczone gel is indicated for the topical treatment of acne vulgaris. It is not for oral, ophthalmic, or intravaginal use. Aczone Gel is contraindicated in patients who are hypersensitive to dapsone or to any ingredient in the formulation or component of the container. Combination of Aczone Gel with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of haemolysis in patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency.
The most common events reported from the clinical trials with Aczone gel include oiliness/peeling, dryness, and erythema. Serious adverse events reported in patients treated with Aczone gel during clinical trials included but were not limited to severe pharyngitis, abdominal pain, severe vomiting, pancreatitis, suicide attempt, tonic clonic movements.
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.