On August 6, 2015 Dr. Reddy ’ s Laboratories Ltd. (NYSE: RDY) reported that it has entered into a strategic collaboration with Amgen – one of the world ’ s leading independent biotechnology companies – to market and distribute three Amgen medicines in India in the area s of oncology and cardiology (Press release, Dr Reddy’s, AUG 6, 2015, View Source [SID:SID1234515194]). Under the terms of the collaboration , Dr. Reddy ’ s shall perform a full range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), BLINCYTO (blinatumomab) and Repatha (evolocumab) in India. The collaboration leverages the capabilities of both companies , combining three of Amgen ’ s innovative therapies with Dr. Reddy ’ s deep understanding of patient and physician needs in India.
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Dr. Reddy ’ s Executive Vice President and Head of India Business & Global Business Development Alok Sonig stated, " We are excited about our strategic collaboration with an innovation powerhouse like Amgen and look forward to making their innovative medicines accessible to Indian patients. Addressing significant unmet needs of patients in oncology and cardiovascular are key area s in India and , therefore, a priority for us at Dr. Reddy ’ s. We believe that good health can’t wait and that this is an important milestone for us in our journey as we improve patient care. "
" We are pleased to be joining forces with Dr. Reddy ’ s Laboratories in order to make Amgen ’ s innovative medicines available to patients in India, " said Penny Wan, Amgen vice president and general manager, Japan Asia Pacific Region. " Dr. Reddy ’ s has significant experience serving oncology and cardiovascular patients in India and shares Amgen ’ s interest in delivering new treatment options to seriously ill patients."
Kyprolis was approved by the U.S. Food and Drug Administration in July 2015, in combination with lenalidomide and dexamethasone, for the treatment of patients with relapsed multiple myeloma who have received o ne 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. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. A form of blood cancer that a rises from plasma cells, multiple myeloma usually grows in bone marrow, the soft, tissue found inside most bones where normal blood cells are produced.
BLINCYTO is an example of immunotherapy, a treatment that uses certain parts of a person ’ s immune syst em to fight diseases such as cancer. BLINCYTO is the first approved bispecific CD19 – directed CD3 T – c ell 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 U.S. FDA in 2014, t o treat patients with Philadelphia chromosome – negative relapsed or refractory B – cell precursor acute lymphoblastic leukemia (B – cell ALL), an uncommon form of ALL. This indication is approved under accelerated approval. Continued approval for this indicatio n may be contingent upon verification of clinical benefit in subsequent trials.
In July, this year, the European Commission (EC) granted marketing authorisation for Repatha , the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with 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.