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Astex Pharmaceuticals Celebrates as Second New Cancer Drug Receives US Marketing Approval

  • Further Milestone from Janssen on NDA Approval by the US FDA of
    BALVERSA™ (erdafitinib) for the Treatment of Urothelial Cancer

CAMBRIDGE, England–(BUSINESS WIRE)–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.ˮ

-ENDS

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.

Contacts

At the Company:
Jeremy Carmichael
VP Corporate
Development
Head of Business Development
Tel: +44(0)1223 226289
Email:
[email protected]

For Media Enquiries:
Sue Charles / Ashley Tapp
Instinctif
Partners
Tel: +44 (0)20 7866 7863
Email: [email protected]

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