Cipher Pharmaceuticals Extends Isotretinoin Distribution Agreement with Ranbaxy
By C. Rajan
Cipher Pharmaceuticals has announced another distribution and supply agreement with Ranbaxy for the exclusive rights to market and sell its isotretinoin capsules in Brazil. Ranbaxy already has exclusive sales and distribution rights in the United States for Cipher's isotretinoin product under the brand name Absorica, since the drug was launched in November 2012.
The agreement with Ranbaxy will provide Cipher an upfront payment and any additional pre-commercial milestone payments. The product will be supplied to Ranbaxy following manufacturing by Cipher's partner, Galephar Pharmaceutical Research. Ranbaxy will be entirely responsible for all activities associated with gaining and maintaining regulatory approval of the product in Brazil. Ranbaxy will be promoting the product in Brazil through a brand dermatology division. After regulatory approval, this product is expected to play a key role in Ranbaxy's dermatology line of products.
"Ranbaxy has been an excellent partner on our isotretinoin product and is a logical choice to commercialize it in Brazil," said Shawn O'Brien, President and CEO of Cipher Pharmaceuticals. "Brazil is the largest isotretinoin market in Latin America, with annual sales exceeding CDN$50 million, and the market has been growing solidly, providing a compelling opportunity for our novel formulation." Indeed, the drug has been pulling its weight outside Latin America, as well. According to the IMS, the U.S. market for isotretinoin was $0.6 billion in 2013, and it is expected to increase by 15 percent every year.
Isotretinoin is used to treat severe, recalcitrant nodular acne, and is prescribed by a dermatologist. It is generally used when other typical acne treatments have failed. Isotretinoin belongs to the retinoid class of medicines, which are related to vitamin A. It works by reducing the production of the skin's natural oils, and it also reduces inflammation. Isotretinoin is also found to be effective in treating other conditions, such as Rosacea, Folliculitis, and other skin disorders.
Due to its lower dependence on patient compliance, the product is the most effective severe acne therapy available to teenagers. The product is marketed in the United States as Absorica and in Canada as Epuris. The extension of the companies’ distribution deal comes on the heels of more recent good news for Ranbaxy, which has had several regulatory troubles in the past year. Last month, the FDA gave Ranbaxy the much-awaited approval to make its exclusive generic version of the Novartis heart drug Diovan at its plant in New Jersey. Ranbaxy is also in the midst of a takeover by India's Sun Pharmaceuticals, which has agreed to buy Ranbaxy for $3.2 billion in stock from its Japanese parent company, Daiichi Sankyo, as well as absorb $800 million of Ranbaxy’s debt.