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15 April, 2019 - 09:16 By Tony Quested

Astex already cashing in on $16bn market

Harren Jhoti

Cambridge-based Astex Pharmaceuticals, dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, is part of an elite tilting at an epigenetics drugs and diagnostic technologies market tipped to reach more than $16 billion in the next five years.

Astex, whose European HQ is based at Cambridge Science Park, has received a significant but unspecified milestone payment from Janssen Pharmaceutical N.V. following a key FDA approval.

The FDA backed BALVERSA™ (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma.

BALVERSA is a once-daily, oral pan-FGFR inhibitor 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™ 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 FDA last September. 

Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the US.  

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, underlining the quality of UK science and strengths in academic-biotech collaboration.

Harren Jhoti, 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.”

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