Prestige BioPharma ("Prestige") announced today that it has reached a licensing agreement with Cipla Limited ("Cipla") for its trastuzumab biosimilar (HD201) under which Cipla will have exclusive rights to distribute and market the drug in selected emerging markets.
HD201 is a mAb biosimilar to Roche’s Herceptin® which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Prestige’s HD201 is in Phase 3 clinical development for filing with European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2019.
This agreement will leverage Cipla’s strong local presence, sales and marketing capabilities in these markets. Prestige will be responsible for full development, product registration with EMA, and commercial supply of HD201 out of its manufacturing facilities in Osong, South Korea.
Lisa S. Park, Chief Executive Officer, Prestige, said: "We are very pleased to partner with Cipla to commercialize our lead biosimilar program in selected emerging markets. With this partnership, we made another important step towards a broad global availability of our Trastuzumab biosimilar product."
Umang Vohra, Managing Director & Global Chief Executive Officer, Cipla, said: "Cipla has always stood for access to life-saving medicines, and through this partnership, we take this key drug to more countries and patients around the world. We will continue to focus on capitalising on our strengths to ensure high-quality medicines to patients in keeping with our purpose of ‘Caring for Life’."
About Prestige BioPharma
Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 Trastuzumab biosimilar, is under Phase 3 clinical development and will be filed with EMA and USFDA in 2019. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase 1, an Adalimumab biosimilar (PBP1502) and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages. Manufacturing facilities for global commercial supply are located in Osong, South Korea. For more, please visit www.prestigebiopharma.com, or click on Facebook, LinkedIn.
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.
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