FDA Grants Pancreatic Cancer Treatment Orphan Drug Designation

XOMA Corporation announced NIS793 in combination with standard of care chemotherapy has been granted Orphan Drug Designation in pancreatic cancer by the U.S. FDA. NIS793 is a potential first in class novel antibody specific for Transforming Growth Factor Beta (TGFβ). An Orphan Drug Designation grants special status to a drug that treats a rare disease or condition and provides companies certain benefits to encourage the continued development of medicines that bring novel solutions to patients with these severe diseases.  

“Pancreatic cancer is a particularly difficult diagnosis for a patient to receive. The statistics clearly demonstrate pancreatic cancer is an unmet medical need, and we are highly supportive of Novartis’ efforts to bring NIS793 to this patient population,” said Jim Neal, Chief Executive Officer at XOMA. 

Under the terms of the 2015 agreement between XOMA and Novartis, XOMA has the potential to earn up to $445 million in additional milestone payments. Upon receipt of regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on any net product sales that range from the mid-single digits to the low double digits.  

NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.