Astex Achieves Milestone on US FDA Filing of New Drug Application (NDA) for LEE011 (ribociclib) plus letrozole as a first-line treatment for HR+/HER2- Advanced Breast Cancer

Astex Achieves Milestone on US FDA Filing of New Drug Application (NDA) for LEE011 (ribociclib) plus letrozole as a first-line treatment for HR+/HER2- Advanced Breast Cancer

  • LEE011 (ribociclib) was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals
  • LEE011 (ribociclib) plus letrozole significantly extended progression-free survival across all patient subgroups in the pivotal Phase 3 MONALEESA-2 clinical study compared to letrozole alone
  • Separately, Novartis announced today that the US Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib)
  • A Novartis marketing authorization application for LEE011 (ribociclib) plus letrozole has also been accepted for review by the European Medicines Agency (EMA)

Cambridge, UK, 1st November 2016. Astex Pharmaceuticals, 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 Novartis in relation to the US FDA NDA filing by Novartis for  LEE011 (ribociclib) plus letrozole as a first-line treatment for HR+/HER2- advanced breast  cancer. Novartis also announced that it had received FDA Priority Review for the NDA  application of LEE011 as first-line treatment of postmenopausal women with hormonereceptor  positive, human epidermal growth factor receptor-2 negative (HR+/HER2-)  advanced or metastatic breast cancer in combination with letrozole.
LEE011 (ribociclib) was developed by the Novartis Institutes for BioMedical Research  (NIBR) under a research collaboration with Astex. Under the collaboration, which  commenced in 2005, NIBR scientists worked with Astex on a programme of early drug  discovery research resulting in the discovery of LEE011. Novartis then led LEE011 into  preclinical and later clinical development. Under terms of the agreement, Astex is eligible to  receive further milestone payments in respect of additional regulatory filing and approvals in  Europe and Japan, as well as royalty payment on annual sales of ribociclib should the drug  be approved.  Harren Jhoti, President and CEO of Astex, said, “We are absolutely delighted that Novartis  has reached such a significant stage in the development of LEE011. If the product is  approved, it will provide an important treatment option for many patients with advanced  disease. We congratulate Novartis for an excellent job in developing LEE011 and on the  achievement of US FDA Priority Review of the NDA filing.”

About LEE011 (ribociclib)

LEE011 (ribociclib) is   selective cyclin dependent kinase inhibitor, a class of drugs that help  slow the progression of cancer by inhibiting two proteins called cyclin dependent kinase 4  and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to  grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in  ensuring cancer cells do not grow uncontrollably.

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.com/en/

CONTACT:

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK
Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: email_jc