Puma Biotechnology, Inc., a development stage biopharmaceutical company, focuses on the acquisition, development, and commercialization of products to enhance cancer care. Product Candidates PB272 (neratinib (oral))—Breast Cancer: Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Neratinib has clinical application in the treatment of several cancers, including breast cancer, non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. PB272 (neratinib (intravenous))—Breast Cancer: The company also intends to develop neratinib as an intravenously administered agent. In pre-clinical studies, the intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models. PB357: PB357 is an orally administered agent that is an irreversible tyrosine kinase inhibitor (TKI), that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. PB357 is structurally similar to PB272. Pfizer Inc. had completed single dose Phase I trials of PB357. PB272 (neratinib (intravenous)): The company also intends to develop neratinib as an intravenously administered agent. PB357: B357 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. Intellectual Property The company holds a worldwide exclusive license under its license agreement with Pfizer Inc. 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 lead 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. Research and Development The research and development of the company’s product candidates totaled $45.1 million for the period ended December 31, 2013. Strategy The company’s strategy is to become an oncology-focused biopharmaceutical company. The main elements of its strategy are as follows: advancing PB272 (neratinib (oral)), its lead drug candidate, toward regulatory approval and commercialization; expanding its product pipeline by pursuing additional applications of neratinib; focusing on developing innovative cancer therapies; building a sustainable pipeline by employing multiple therapeutic approaches and disciplined decision criteria based on clearly defined proof of principal goals; and evaluating the commercialization strategies on a product-by-product basis in order to maximize the value of each. Government Regulation The company’s drug product candidates are marketed in the United States after the drug has received the U.S. Food and Drug Administration approval. History Puma Biotechnology, Inc. was founded in 2010.
puma biotechnology inc
(PBYI:New York Consolidated)
10880 Wilshire Boulevard
Los Angeles, CA 90024
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