Canada's Cipher Pharmaceuticals has been given the green light in the USA for an acne treatment that will be marketed by Ranbaxy Laboratories.
The US Food and Drug Administration has approved Absorica, Cipher's patented brand formulation of the acne medication isotretinoin, specifically for the treatment of severe recalcitrant nodular acne. The thumbs-up triggers a $9.0 million milestone from Ranbaxy, approximately half of which will be shared with its development partner Galephar Pharmaceutical Research.
Cipher will also receive royalties and is eligible for future milestone payments from Ranbaxy which holds the US rights to the product. Absorica is expected to be launched in the fourth quarter into a market valued at about $400 million.
Venkat Krishnan, regional director for Ranbaxy in the Americas, said that Absorica is "a critical milestone in our commitment to serve the dermatology community and will be the flagship brand" for his firm's specialised dermatology sales force.
Cipher has now had three products approved by the FDA. The others are a fenofibrate formulation marketed as Lipofen and ConZip, known as Durela in Canada, an extended-release version of tramadol.