Andarix Pharmaceuticals Receives Pancreatic Cancer Orphan Drug Designation from the FDA
Targeted therapy for pancreatic cancer is based on personalized medicine approach
ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for lung cancer announced today that Tozaride, the Company’s lead candidate for targeted peptide therapy, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of pancreatic cancer.
Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees. The OOPD also works on rare disease issues with the medical and research communities, professional organizations, academia, industry, and rare disease patient groups.
Tozaride is a potential breakthrough therapy for pancreatic cancer because patients will first be screened with its companion diagnostic, and only those patients who may be positive responders to the drug will be treated. Pancreatic cancer is responsible for significant cancer mortality in the United States, with over 50,000 new diagnoses and over 50,000 deaths attributable to this disease annually. “Tozaride is designed to provide additional, and personalized treatment options for patients with pancreatic cancer,” stated Chris Adams, Chief Executive Officer of Andarix. “We are greatly encouraged by the results from our preclinical research to date. Our next step is to initiate clinical studies to demonstrate the value of this therapy for pancreatic cancer patients.”
Tozaride is a novel, best-in-class therapy for lung, pancreatic and other cancers based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for pancreatic as well as small cell (SCLC), and non-small cell (NSCLC) patients, and which will provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.
About Andarix Pharmaceuticals
Andarix Pharmaceuticals is at the forefront of personalized therapies for cancer, developing both the imaging agents that can identify appropriate patients, as well as the targeted therapies for these patients. The company’s products have progressed through
early clinical development. The Andarix technology is based on a proprietary somatostatin peptide conjugate applicable to lung, pancreatic, neuroendocrine, and other cancers. Extensive research has demonstrated that somatostatin receptors are highly up-regulated on several different types of solid tumors. To learn more about Andarix, please visit www.andarix.com.