GUANGZHOU, China I January 14, 2019 I Bio-Thera Solutions Ltd (“Bio-Thera”) announced today that it has reached a licensing agreement with Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets.
BAT-1706 is a mAb biosimilar to Genentech’s Avastin® which is currently approved for six indications including metastatic colorectal cancer, recurrent glioblastoma and non-squamous non-small cell lung cancer. Bio-Thera’s BAT-1706 is currently in a global Phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) in 2020.
This partnership will leverage Cipla’s strong local presence, sales and marketing capabilities in the select emerging markets. Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.
“Bio-Thera is pleased to partner with Cipla to commercialize our lead biosimilar program in select emerging markets”, said Dr. Shengfeng Li, CEO of Bio-Thera. “This partnership is an important first step towards making BAT1706, our bevacizumab biosimilar product, availability globally to help increase patient access to this important cancer therapeutic at affordable prices.”
“This agreement is in keeping with Cipla’s stated intention to build a strong pipeline of biosimilars through partnerships. We are committed to working towards ensuring patients receive access to life-saving drugs. Through this partnership, Cipla will leverage its strengths in marketing to take this key oncology biosimilar to patients in need.” said Umang Vohra, MD & Global CEO of Cipla Limited.
About Bio-Thera Solutions
Bio-Thera Solutions Ltd, a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has applied for marketing authorization for one candidate. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
About Cipla Limited:
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Our 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Sept’18), 3rd largest in the pharma private market in South Africa (IQVIA YTD Aug’18), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.
SOURCE: Bio-Thera Solutions
Post Views: 167
GUANGZHOU, China I January 14, 2019 I Bio-Thera Solutions Ltd (“Bio-Thera”) announced today that it has reached a licensing agreement with Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets.
BAT-1706 is a mAb biosimilar to Genentech’s Avastin® which is currently approved for six indications including metastatic colorectal cancer, recurrent glioblastoma and non-squamous non-small cell lung cancer. Bio-Thera’s BAT-1706 is currently in a global Phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) in 2020.
This partnership will leverage Cipla’s strong local presence, sales and marketing capabilities in the select emerging markets. Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.
“Bio-Thera is pleased to partner with Cipla to commercialize our lead biosimilar program in select emerging markets”, said Dr. Shengfeng Li, CEO of Bio-Thera. “This partnership is an important first step towards making BAT1706, our bevacizumab biosimilar product, availability globally to help increase patient access to this important cancer therapeutic at affordable prices.”
“This agreement is in keeping with Cipla’s stated intention to build a strong pipeline of biosimilars through partnerships. We are committed to working towards ensuring patients receive access to life-saving drugs. Through this partnership, Cipla will leverage its strengths in marketing to take this key oncology biosimilar to patients in need.” said Umang Vohra, MD & Global CEO of Cipla Limited.
About Bio-Thera Solutions
Bio-Thera Solutions Ltd, a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has applied for marketing authorization for one candidate. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
About Cipla Limited:
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Our 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Sept’18), 3rd largest in the pharma private market in South Africa (IQVIA YTD Aug’18), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.
SOURCE: Bio-Thera Solutions
Post Views: 167
