Puma Biotechnology, Inc., a biopharmaceutical company, focuses on the development and commercialization of products to enhance cancer care. The company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)), and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. The company focuses on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The company’s initial focus is on the development of the oral formulation of neratinib. It is also evaluating for potential development an intravenous formulation of neratinib and PB357, a back-up compound to neratinib. The company completed a Phase III clinical trial of neratinib for the extended adjuvant treatment of women with early stage HER2-positive breast cancer, which refers to as the ExteNET trial. The company has an agreement with the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), for a planned Phase III clinical trial of PB272 in patients with HER2-positive metastatic breast cancer who have failed two or more prior treatments (third-line disease). In 2015, the company announced that it expanded the cohort from the Phase II clinical trial of PB272 in patients with metastatic non-small cell lung cancer that is not HER2 amplified or overexpressed (HER2 negative) and has a HER2 mutation. In December 2015, the company announced that it expanded the cohort that includes patients with metastatic biliary duct (bile duct) cancer that is not HER2 amplified or overexpressed (HER2 negative) and has a HER2 mutation. The company plans to develop neratinib as an intravenously administered agent. The intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models. PB357 is an orally administered agent that is an irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. PB357 is structurally similar to PB272. Pfizer, Inc. completed single-dose Phase I trials of PB357. The company is evaluating PB357 and considering options relative to its development. Strategy The company’s strategy is to become a leading oncology-focused biopharmaceutical company. The key elements of the company’s strategy are to seek regulatory approval and commence commercialization of neratinib in its lead indication; continue to advance the development of neratinib for the treatment of other HER2-positive breast cancer indications; expand its product pipeline by pursuing additional applications of neratinib; build a sustainable product pipeline by employing multiple therapeutic approaches and disciplined decision criteria based on clearly defined proof of principal goals; and evaluate the commercialization strategies on a product-by-product basis in order to maximize the value of each. Research and Development Expenses Research and development activities, which include personnel costs, research supplies, clinical and pre-clinical study costs, are the primary source of the company’s overall expenses. Such expenses related to the research and development of the company’s product candidates totaled $208.5 million for the year ended December 31, 2015. Intellectual Property and License Agreements The company holds a worldwide exclusive license under its license agreement with Pfizer to four granted U.S. patents and nine pending U.S. patent applications, as well as foreign counterparts thereof, and other patent applications and patents claiming priority therefrom. In the United States, the company has a license to an issued patent, which would expire in 2025, for the composition of matter of neratinib, its primary compound. The company has a license to an issued U.S. patent covering a family of compounds, including neratinib, as well as equivalent patents in the European Union and Japan that expire in 2019. The company also has a license to an issued U.S. patent for the use of neratinib in the treatment of breast cancer, which expires in 2025, and an issued U.S. polymorph patent for neratinib, which expires in 2028. History Puma Biotechnology, Inc. was founded in 2010.
puma biotechnology inc (PBYI:New York)
10880 Wilshire Boulevard
Los Angeles, CA 90024
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