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2022 News Releases
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PBYI: Alisertib License Agreement Slides
Puma Biotechnology Announces Exclusive License Agreement with Takeda for the Development and Commercialization of Alisertib, an Investigational Aurora Kinase A Inhibitor
LOS ANGELES, Calif., Sept. 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).
“There continues to be a need for new drugs for the treatment of metastatic ER- positive, HER2-negative
breast cancer and triple negative breast cancer,” said Joyce A. O’Shaughnessy, M.D., the Celebrating
Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and
Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. “The results from the
clinical trials of alisertib in these two indications are encouraging and suggest that the drug may be able
to provide a clinical benefit to these patient populations, and, due to its novel mechanism, alisertib may
be able to provide a benefit in patients who have developed resistance to other treatments modalities,”
said Dr. O’Shaughnessy.
“Treatment options for patients with small cell lung cancer that has progressed on or after platinum-based
chemotherapy are limited, and there is an urgent need for new drugs to treat this patient population,” said
Taofeek K. Owonikoko, MD, PhD, Chief of the Division of Hematology/Oncology and Associate
Director for Translational Research and Co-Leader of the Cancer Therapeutics Program at the UPMC
Hillman Cancer Center. “The results from the clinical trials of alisertib in small cell lung cancer suggest
that the drug may represent a potentially promising treatment option for these patients and more
specifically for patients with molecularly defined tumors that are likely to respond to an aurora kinase A
inhibitor such as alisertib,” said Dr. Owonikoko.
Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma stated, “We are pleased to be
able to complete this licensing agreement with Takeda for alisertib. To date, alisertib has demonstrated
strong evidence of antitumor activity, both as a single agent and in combination with other anticancer
drugs, in patients with metastatic ER-positive and triple negative breast cancer, as well as in small cell
lung cancer. We look forward to the continued development of alisertib.”
Puma will host a conference call today at 2:00 p.m. PDT/5:00 p.m. EDT to discuss the alisertib licensing
agreement. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354
(international). Please dial in at least 10 minutes in advance and inform the operator that you would like
to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and
presentation slides may be accessed on the Investors section of the Puma Biotechnology website at
https://www.pumabiotechnology.com. A replay of the call will be available shortly after completion of
the call and will be archived on Puma’s website for 90 days.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and
commercialization of innovative products to enhance cancer care. Puma in-licenses the global development
and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.
Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant
treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant
trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In
February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the
treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two
or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing
authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients
with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less
than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered
trademark of Puma Biotechnology, Inc.
Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the development and
commercialization of alisertib. All forward-looking statements involve risks and uncertainties that could
cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in
these forward-looking statements. These statements are based on current expectations, forecasts and
assumptions, and actual outcomes and results could differ materially from these statements due to a number
of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports
filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual
Report on Form 10-K for the year ended December 31, 2021 and subsequent reports. Readers are cautioned
not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
Puma assumes no obligation to update these forward-looking statements, except as required by law.
Contact:
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., (424) 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Olipriya Das, Russo Partners, (212) 845 4200
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
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