Dr. Reddy's Launches Generic Dacogen

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Dr. Reddy's Laboratories Ltd. (RDY) recently announced the launch of its therapeutic equivalent generic version of Astex Pharmaceuticals, Inc. /Eisai Co., Ltd.’s (ASTX/ ESALY) Dacogen. The 50 mg injection dose of Dacogen is available as a single-dose vial in the US.

Dacogen is approved for the treatment of patients with myelodysplastic syndromes (:MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes, and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System (:IPSS) groups. According to IMS Health, Dacogen generated US revenues of approximately $260 million MAT (moving annual total) in the last 12 months ending Jul 2013.

Currently, the MDS market has drugs like Vidaza and Revlimid. Many candidates are being developed for the treatment of MDS, like Astex’ SGI-110, to treat patients with intermediate or high risk relapsed or refractory MDS. Another candidate, Telintra, is being developed for MDS.

Dr. Reddy's boasts of a strong generic product portfolio. Revenues at the Global Generics segment were up 17.5% to $1.5 billion in fiscal year ended Mar 31, 2013. Strong sales in North America and emerging markets were primarily responsible for the growth displayed by the Global Generics division. Generics revenue increased in North America (up 19%), Russia (up 27%), other CIS (Commonwealth of Independent States) markets (up 28%), India (up 13%) and the rest of the world/RoW (up 42%). 

During fiscal 2013, Dr. Reddy’s filed 18 abbreviated new drug applications (ANDAs) with the FDA. Dr. Reddy’s had 65 ANDAs pending approval with the FDA at the end of fiscal 2013.

Dr. Reddy's carries a Zacks Rank #4 (Sell). Currently, Mylan, Inc. (MYL) looks more attractive with a Zacks Rank #2 (Buy).

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