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Dr. Reddy’s To Market And Distribute Amgen’s Repatha (Evolocumab), Kyprolis (Carfilzomib) And Blincyto (blinatumomab) In India Upon Approval

Published: Aug 5, 2015 9:30 pm
Dr. Reddy’s To Market And Distribute Amgen’s Repatha (Evolocumab), Kyprolis (Carfilzomib) And Blincyto (blinatumomab) In India Upon Approval

Hyderabad, India (Press Release) – Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced 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 areas of on­col­ogy and cardiology. 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.

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 areas 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 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. 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 arises 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 sys­tem to fight diseases such as cancer. BLINCYTO® is the first approved 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 U.S. 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. This indi­ca­tion is approved under accelerated approval. Continued approval for this indi­ca­tion 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.

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. is an integrated pharma­ceu­tical com­pany, committed to accelerating access to affordable and inno­va­tive med­i­cines, because it believes Good Health Can’t Wait. Through its three businesses - Pharma­ceu­tical Services & Active Ingredients, Global Generics and Proprietary Products – the com­pany offers a portfolio of prod­ucts and services that in­clude active pharma­ceu­tical ingredients, (APIs), custom pharma­ceu­tical services, generics, bio­sim­i­lars and dif­fer­en­ti­ated for­mu­la­tions. With operations in 26 countries across the globe, the major thera­peutic areas of Dr. Reddy’s are gastro-intestinal, cardiovascular, diabetology, on­col­ogy, pain man­agement and anti-infectives. For more in­for­ma­tion, log on to: www.drreddys.com

Disclaimer

This press release may in­clude state­ments of future ex­pec­ta­tions and other for­ward-looking state­ments that are based on the man­agement’s current views and assump­tions and involve known or unknown risks and un­cer­tain­ties that could cause actual results, per­for­mance or events to differ ma­teri­ally from those ex­pressed or implied in such state­ments. In addi­tion to state­ments which are for­ward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "antic­i­pates", "believes", "estimates", "predicts", "potential", or "continue" and similar ex­pres­sions identify for­ward-looking state­ments. Actual results, per­for­mance or events may differ ma­teri­ally from those in such state­ments due to without limitation, (i) general economic con­di­tions such as per­for­mance of financial mar­kets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of com­pe­ti­tion and general competitive factors, (iv) changes in laws and reg­u­la­tions and in the policies of central banks and/or gov­ern­ments, (v) the impact of acquisitions or re­organ­i­sa­tion, in­clud­ing related integration issues.

Source: Dr. Reddy's.

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