Otsuka Pharmaceutical Co., Ltd.

November 22, 2023

Otsuka's U.K. subsidiary Astex Has Third Approval Success in a Drug Discovery Collaboration
- AstraZeneca's Truqap™ for the treatment of metastatic breast cancer approved in the U.S.

  • Astex is eligible to receive a milestone payment and royalties on sales of the new drug under its 2005 collaboration and licence agreement with AstraZeneca
  • Truqap, a first-in-class AKT inhibitor, was discovered by AstraZeneca subsequent to its discovery collaboration with Astex and Astex's earlier drug discovery collaboration with the Institute of Cancer Research, London
  • AstaZeneca's Truqap™ follows Novartis' Kisqali® and Janssen's BALVERSA® as the third drug to receive market approval based on collaborations that have utilised Astex's pioneering fragment-based drug discovery approach

Otsuka Pharmaceutical Co., Ltd.'s (Otsuka) wholly owned subsidiary Astex Pharmaceuticals in Cambridge, U.K., (Astex), announced that it will receive a milestone payment from AstraZeneca PLC (AstaZeneca) on first commercial sale of the drug Truqap and receive royalties from AstraZeneca on future sales following U.S. FDA approval of Truqap™ plus Faslodex® as a treatment for adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

Truqap is a first-in-class oral targeted inhibitor of the cancer-driving protein AKT, also known as PKB. Truqap was discovered by AstraZeneca following an earlier drug discovery research collaboration between Astex, The Institute of Cancer Research, London, and Cancer Research Technology (now Cancer Research Horizons) that was signed in 2003. As part of that earlier foundational research, Astex and The Institute of Cancer Research used the 3D X-ray crystal structure of the AKT protein target to identify small molecule modulators of AKT activity using an approach known as fragment-based drug discovery.