- Further Milestone from Janssen on NDA Approval by the US FDA of BALVERSA™ (erdafitinib) for the Treatment of Urothelial Cancer
Cambridge, UK, 12 April 2019. 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 it has received a milestone payment from Janssen Pharmaceutica N.V. (Janssen). This follows the United States Food and Drug Administration’s (FDA) accelerated review and approval of a Janssen New Drug Application (NDA) for BALVERSA™ (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
BALVERSA™ (erdafitinib) is a once-daily, oral pan-FGFR inhibitor that was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and licence agreement to identify novel, small molecule inhibitors of FGFR kinase, including for the treatment of cancer. Under the ongoing collaboration, Janssen is responsible for the clinical development and commercialisation of all products, including erdafitinib. Astex is eligible to receive further milestone payments on additional regulatory filings and approvals in the US and Europe and for additional indications, as well as tiered double-digit royalty payments on annual sales of erdafitinib.
BALVERSA™ (erdafitinib) received Breakthrough Therapy Designation from the FDA for the treatment of patients with metastatic urothelial cancer in March 2018 and Janssen announced submission of an NDA seeking its approval to the US FDA in September 2018. Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.
Before entering into its exclusive worldwide collaboration and licence agreement with Janssen, Astex performed pioneering work on FGFR with the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre, Northern Institute for Cancer Research, Newcastle University, UK, underlining the quality of UK science and strengths in academic-biotech collaboration.
Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “‘We are delighted with the approval of BALVERSA™ and congratulate our valued colleagues at Janssen for their determination and excellent work in the discovery and development of this new medicine. We also congratulate our academic collaborators at Newcastle University for their contribution to our pioneering early collaboration on FGFR that aided in its discovery. Astex continues to strive to discover new medicines for cancer patients and is very proud that BALVERSA™ is the second of our Pharma-partnered products to have been approved in the last two years.’
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.
For more information about Astex Pharmaceuticals, please visit http://www.astx.com
For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/
BALVERSA is a trademark of Janssen Biotech, Inc.
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