Puma Biotechnology, Inc. a biopharmaceutical company, announced that the United States Patent and Trademark Office (USPTO) issued a Patent Term Extension Certificate for U.S. Patent No. 7,399,865, extending the patent term five (5) years.
The patent includes composition of matter claims for NERLYNX® and will now expire on December 29, 2030. The patent term extension is pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, also referred to as the Hatch-Waxman Amendments, which permits an extension of the term of one patent for a maximum period of five years.“ We are very pleased to have the patent term for NERLYNX extended to 2030. This will allow us to invest further in the drug to look at additional ways that the drug can continue to help cancer patients,” said Alan H. Auerbach, Chief Executive Officer and President of Puma.
About HER2-Positive Breast Cancer
Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.
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. y stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and 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,