Dr. Reddy’s Amgen Sign Distribution PactBy
Dr. Reddy's Laboratories Ltd. has entered into a strategic collaboration with Amgen to market and distribute three Amgen medicines in India in the areas of oncology and cardiology. Under the collaboration, Dr. Reddy's willperform a full range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), Blincyto (blinatumomab) and Repatha (evolocumab) in India.
Kyprolis was approved by the US Food and Drug Administration (FDA) in July 2015, in combination with lenalidomide and dexamethasone, for treating relapsed multiple myeloma in patients who have received one to three prior lines of therapy. Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Blincyto is a bispecific CD19-directed CD3 T-cell engager. It engages the body's T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. It was approved by the the FDA in 2014, to treat patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
In July 2015, the European Commission (EC) granted marketing authorization for Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to for treating uncontrolled cholesterol despite taking maximum doses of statins or who cannot take statins, who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction. Elevated LDL-C or “bad” cholesterol is an abnormality of cholesterol and/or fats in the blood and is recognized as a major risk factor for cardiovascular disease.
Source: Dr. Reddy’s Laboratories