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Sun Pharmaceutical Industries Ltd.

Drug Names(s): CIP-Isotretinoin, CIP Isotretinoin, Epuris (Canada), Lisacne-CIP (Chile)

Description: CIP-ISOTRETINOIN, which is based on the Lidose drug delivery system, is a reformulation of the acne medication isotretinoin.

Isotretinoin is a retinoid. Retinoids exert their anti-neoplastic effects by regulating the expression of genes involved in cell growth, differentiation, apoptosis, tumor-associated angiogenesis, and host immune functions. Retinoids mediate the transcription of genes through retinoid nuclear receptors. Retinoid receptors are divided into retinoid X receptors (RXRs) and retinoic acid receptors (RARs). Isotretinoin acts primarily on the RAR family of receptors.

Deal Structure: Cipher and Ranbaxy
In August 2008, Cipher Pharmaceuticals announced that it has entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals (RPI) (a subsidiary of Daiichi Sankyo) under which Cipher has granted RPI the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States, its territories and possessions.

Under the terms of the agreement with RPI, Cipher received an initial upfront milestone payment of $1 million. The agreement includes additional pre- and post-commercialization milestone payments of up to $23 million, contingent upon the achievement of certain milestone targets. Once the product is successfully commercialized, Cipher will also receive a royalty in the mid-teens on net sales. In addition, RPI will reimburse Cipher for all costs associated with the clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial...See full deal structure in Biomedtracker

Partners: Daiichi Sankyo Co., Ltd. Cipher Pharmaceuticals Inc.

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