Andarix Pharmaceuticals Receives Pancreatic Cancer Orphan Drug Designation from the FDA

In Press Release by Cameron

ANDARIX Pharmaceuticals

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 cancer announced today that Tozaride, the Company’s lead candidate, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of pancreatic cancer. 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. This is the second designation for Tozaride which also received Orphan Drug designation for small cell lung cancer earlier this year.

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.

“Tozaride is a potential breakthrough therapy for pancreatic cancer patients because only those patients who are most likely to respond, identified with Tozaride’s unique companion diagnostic, will be treated with the drug. Tozaride could provide an additional, greatly needed treatment option for patients with pancreatic cancer,” stated Rhonda Wallen, Chief Operating Officer of Andarix. “We are encouraged by the results of our animal research to date, and are working diligently to advance this therapy into clinical development for the pancreatic cancer patient population.”

About Tozaride
Tozaride is a novel, best-in-class cancer therapy 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 both lung cancer (SCLC, NSCLC), and pancreatic cancer patients. Along with its companion diagnostic that helps identify patients most likely to respond – those with sufficient expression of the peptide’s target – Tozaride could 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 solid tumors, particularly lung, neuroendocrine, and pancreatic tumors. To learn more about Andarix, please visit