Puma Biotechnology, Inc. is a biopharmaceutical company dedicated to acquiring, developing, and commercializing innovative therapeutics for cancer treatment. Founded in 2010 by Alan H. Auerbach, the company focuses on in-licensing promising drug candidates that have undergone early-stage clinical testing, aiming to expedite their development and commercialization. Puma's flagship product, NERLYNX® (neratinib), is an FDA-approved oral kinase inhibitor for HER2-positive breast cancer. The company's mission is to advance targeted oncology therapeutics and precision medicine solutions to improve patient outcomes.
Puma Biotechnology's strategic focus centers on developing and commercializing targeted cancer therapies, particularly for HER2-positive breast cancer. The company specializes in precision medicine, utilizing advanced molecular targeting technologies to minimize adverse treatment effects. Its primary market includes oncology treatment centers and healthcare providers specializing in cancer care.
As of December 31, 2024, Puma Biotechnology reported annual revenues of $230.47 million, reflecting a 2.19% decrease from the previous year. The company has raised a total of $809.3 million in funding over seven rounds, with the latest funding round of $10 million raised on March 10, 2022. The capital has been utilized to advance clinical development programs and expand the commercialization of NERLYNX®.
Puma's product pipeline includes alisertib, a selective, small-molecule inhibitor of aurora kinase A, under investigation for treating non-small cell lung cancer and breast cancer. In March 2024, the company received FDA clearance for the clinical development of alisertib for HER2-negative, hormone receptor-positive metastatic breast cancer in the Phase II ALISCA-Breast1 trial. Additionally, in August 2023, the FDA approved the clinical development of alisertib monotherapy for extensive-stage small cell lung cancer.
Puma Biotechnology's technological platform is distinguished by its proprietary development of neratinib, an irreversible pan-HER inhibitor targeting HER2-positive cancers. This innovation has demonstrated a 44% reduction in disease progression for HER2-positive breast cancer patients. The company's intellectual property portfolio includes 17 patent families related to neratinib cancer treatment technologies, valued at approximately $85.3 million as of 2022.
The leadership team is led by Alan H. Auerbach, who serves as Chairman of the Board, President, and Chief Executive Officer. Under his guidance, Puma has successfully developed and commercialized NERLYNX® and advanced its pipeline candidates.
Puma Biotechnology operates in a competitive oncology market, facing competition from companies such as Roche Holding AG, Novartis AG, Pfizer Inc., and AstraZeneca PLC. These competitors offer treatments like Herceptin, Kisqali, and Ibrance, targeting various forms of breast cancer. Puma's focus on precision medicine and targeted therapies positions it uniquely within this landscape.
Puma has established strategic collaborations and licensing agreements to enhance its market presence. In 2019, the company licensed commercialization rights in Europe and parts of Africa to Pierre Fabre for an upfront payment of $60 million and potential milestone payments up to $345 million. Similar agreements have been made with CANbridge Life Sciences in Greater China, Medison Pharma in Israel, Knight Therapeutics in Canada, Specialised Therapeutics in Southeast Asia, and Pint Pharma in Latin America.
Puma Biotechnology's strategic roadmap includes expanding the indications for NERLYNX® and advancing the clinical development of alisertib. The company's commitment to innovation and strategic partnerships positions it to address unmet needs in oncology and improve patient outcomes.
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