Astex Continues to Deliver in Oncology as Erdafitinib, a Potential New Treatment for Metastatic Urothelial Cancer, Receives US FDA Breakthrough Therapy Designation

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that its pharmaceutical collaborator, Janssen Pharmaceutica N.V. (Janssen), has been granted Breakthrough Therapy Designation by the US FDA for erdafitinib in the treatment of metastatic urothelial cancer.

Erdafitinib was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and licence agreement to identify novel, small molecule inhibitors of Fibroblast Growth Factor Receptor (FGFR) kinase, including for the treatment of cancer.  Janssen is responsible for the clinical development and commercialisation of all products arising from this collaboration.

The FGFR inhibitor programme between Astex and Janssen underlines the UK strengths in academic-biotech collaboration as it originated from pioneering work on FGFR between Astex and the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre, Northern Institute for Cancer Research, Newcastle University, UK.

Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.  Breakthrough Therapy Designation allows for the expedited development and regulatory review of erdafitinib as a potential new treatment option for patients with metastatic disease.  It was granted based on positive data from a multicenter, open-label Phase 2 clinical trial.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “This is a great endorsement of our scientific approach and our team.  Astex is committed to the fight against cancer and so is delighted that erdafitinib has been granted Breakthrough Therapy Designation by the US FDA.  Congratulations to our valued collaborators at Janssen for their excellent work in advancing erdafitinib to this exciting stage in its development.”


Notes to Editors

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.  Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

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At the Company

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066