MAA submission in the EU anticipated in second half of 2017
Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim) to treat chemotherapy-induced neutropenia. The trial demonstrated comparability of B12019 and its reference product Neulasta with regards to pharmacodynamics (PD) and immunogenicity. All primary and secondary study endpoints were met.
The multiple-dose, randomised, double-blind, three-period cross-over study enrolled 96 healthy volunteers in Germany. The study design was based on scientific advice from the European Medicines Agency (EMA) and was tailored to the specific properties of pegfilgrastim. The study met its primary endpoints: area under the effect curve (AUEC0-last) for PD and anti-drug antibody rate (ADA) for immunogenicity, confirming comparability to Neulasta. Likewise, all secondary endpoints were achieved. The safety of B12019 was also comparable to Neulasta. Further data from the trial will be presented at upcoming scientific conferences.
Dr Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH, commented:
”The positive results of our second study confirm the biosimilarity of B12019 and Neulasta that we demonstrated in the first trial. Both studies, together with the analytical and functional comparability data, support the high quality of our product candidate. Based on the now available comprehensive data package for B12019, we are preparing to submit for EU approval in the second half of 2017. I am proud of the team for having completed such an efficient clinical development program on time.”
Pegfilgrastim is indicated for the treatment of chemotherapy-induced neutropenia. The pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infection in patients undergoing chemotherapy.
Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. Founded in 2013 and supported by its parent company Cinfa Group, the Company is creating a pipeline of biosimilar drugs for a range of indications to address the growing need for affordable therapies based on proven science, quality, safety and efficacy. A complete team of experts with decades of in-depth experience is conducting product development, clinical studies, manufacturing and quality control, according to the highest European standards. Cinfa Biotech’s first product candidate in clinical development is B12019, a biosimilar version of Neulasta® (pegfilgrastim). The commercialisation models will be customised to the needs of partners and markets.
With 50 years’ experience, Cinfa Group today employs over 1,400 people and reinvests an average of 90% of its annual profits in its portfolio companies, thereby driving their development and innovation. Cinfa Group’s first subsidiary, Laboratorios Cinfa, has become a recognised leader in the Spanish pharmaceutical market. As part of the internationalization strategy, the company also serves in currently over 50 countries and is further expanding.
For more information, please visit: http://www.cinfabiotech.com
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Neulasta® is a registered trademark of Amgen Inc.