Puma Biotechnology Announces Exclusive License Agreement with Takeda for the Development and Commercialization of Alisertib, an Investigational Aurora Kinase A Inhibitor

LOS ANGELES--(BUSINESS WIRE)--Sep 20, 2022--

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, today announced an agreement with Takeda to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A. Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in clinical trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia.

Under the terms of the agreement, Puma will assume sole responsibility for the global development and commercialization of alisertib. Takeda will receive an upfront license fee of $7 million and is eligible to receive potential future milestone payments of up to $287.3 million upon Puma’s achievement of certain regulatory and commercial milestones over the course of the agreement, as well as tiered royalty payments for any net sales of alisertib.

Puma initially intends to focus the development of alisertib on the treatment of patients with metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer. In ER-positive HER2-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015), in a Phase II randomized clinical trial as a single agent compared to a combination with fulvestrant (SABCS 2020) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). In triple-negative breast cancer, alisertib has previously been tested in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (JAMA Network Open 2021). Alisertib has demonstrated meaningful clinical activity in these populations and most notably in ER-positive breast cancer patients who have been previously treated with a CDK4/6 inhibitor (JAMA Network Open 2021). Alisertib has also been previously tested in small cell lung cancer in a Phase II clinical trial as a single agent (Lancet Oncology 2015) and in a Phase II randomized clinical trial in combination with paclitaxel compared to paclitaxel monotherapy (Journal of Thoracic Oncology 2020).