Ranbaxy Laboratories' US based subsidiary Ranbaxy Laboratories Inc., (RLI) has received US FDA approval for Absorica, a novel, patented brand formulation of the acne medication isotretinoin, developed by Cipher, for the treatment of severe recalcitrant nodular acne. RLI has entered business agreement with Ciphar, the Canadian firm, to launch Absorica in the US market. It is expected that the product will be launch in fourth quarter of 2012 and RLI will pay royalties on net sales to Cipher Pharmaceuticals.
Venkat Krishnan, senior vice president and regional director, RLI, said, “We are thrilled to make Absorica available as a valuable option for the dermatologists and patients who need treatment for severe recalcitrant nodular acne. Absorica is a critical milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy’s specialized dermatology sales force.”
RLI has been expanding and growing on the strength of Ranbaxy’s R&D efforts, and continuing exploration of Novel Drug Delivery Systems (NDDS), licensing activities, mergers and acquisitions. RLI is expanding the visibility and presence of the Ranbaxy name by bringing value-added brand products to the market.
Larry Andrews, president and CEO of Cipher said, “Approval of Absorica represents our third FDA approval and most important milestone to date, reflecting the great work by our Scientific Affairs team at Cipher and our partner, Galephar Pharmaceutical Research. We look forward to working closely with our partner, Ranbaxy Laboratories Inc., in preparation for the upcoming U.S. launch of the product through its dermatology sales force.”
As a result of the FDA approval of Absorica, Cipher will receive a US$9 million milestone from Ranbaxy, approximately US$4.5 million of which will be shared with Galephar. This milestone will be reflected in Cipher's cash balance at the end of Q2 2012. Going forward, Cipher will also receive royalties on net US sales and is eligible for future milestone payments based on sales targets. Under the agreement with Ranbaxy, Cipher is responsible for product supply and manufacturing.
Cipher Pharmaceuticals is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher's strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners.