Ranbaxy Labs' Absorica debuts in USA

Indian drugmaker Ranbaxy Laboratories (AB: BO), which is majority owned by Japan’s Daiichi Sankyo, said yesterday that it has launched the sales and promotion in the USA of Absorica (isotretinoin) capsules, a product that is licensed from Cipher Pharmaceuticals of Mississauga, Ontario.

Absorica, which is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older, was approved by the Food and Drug Administration in the spring (The Pharma Letter May 29), generating a $9.0 million milestone from Ranbaxy to Cipher, around $4.5 million of which will be shared with Puerto Rico-based Galephar Pharmaceutical Research.

Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal, however, Absorica, which is formulated using patented Lidose technology, can be given without regards to meals. The fasted AUC0-t of Absorica is around 83% greater than that of Roche’s now off patent Accutane Isotretinoin), while both products are bioequivalent under fed conditions. Absorica is therefore not interchangeable and not substitutable with generic products of Accutane. Absorica’s New Drug Application was approved based on a large pivotal clinical trial enrolling 925 patients.