HANA PREDICTS DELAY OF ZENSANA NDA REVIEW

Hana Biosciences has announced an update on the status of its new drug application (NDA) for Zensana Oral Spray. Hana had submitted an NDA to seek approval for Zensana for the prevention of nausea and vomiting as a result of chemotherapy, radiation and surgery.

Long-term stability studies have detected small amounts of precipitated material in scale-up batches of Zensana (ondansetron HCI), which may require an adjustment to the formulation and/or the manufacturing process. Hana is investigating this issue and awaits results of ongoing experiments. This issue is likely to delay FDA approval of Zensana beyond the expected Prescription Drug User Fee Act action date of April 30.

"We are disappointed by this development with Zensana; however, we are committed to improving stability and pursuing FDA approval of what we believe is a high quality product of real value to patients," Mark Ahn, president and CEO of Hana, said.

Zensana is the first 5-HT3 antagonist to deliver ondansetron, a standard antiemetic therapy, in a convenient micromist oral spray. Based on clinical trial data, Hana believes Zensana is statistically bioequivalent to ondansetron tablets with faster initial delivery time. Ondansetron is widely used in tablet form to prevent nausea and vomiting, but many chemotherapy and radiation patients requiring antiemetic therapy experience dysphagia, a discomfort or difficulty swallowing tablets, due to mouth and throat sores, inflammation or dry mouth. Hana believes that the oral spray may be an attractive alternative to tablets and other forms of ondansetron.