Neose said it expected to receive a formal letter detailing the FDA's requests within 30 days.
"It is important to underscore that the FDA did not express any specific concern about the manufacture of a protein in insect cells, or about the application of our core technology, Glycopegylation," C. Boyd Clarke, Neose's president, chief executive officer and chairman, said during a conference call with analysts yesterday.
Neose is making a long-acting formulation of the protein erythropoietin in insect cells.
"Notwithstanding our disappointment about this delay, we continue to plan for success," he said.
Neose had expected to begin the clinical trial during the third quarter. The company said it now expected the test to be delayed for at least one quarter.
Founded in 1990 on technologies developed at the University of Pennsylvania, Neose still has no product sales after earlier clinical trials for two compounds did not pan out. The company refocused, and it filed an investigational new-drug application for NE-180 on June 23.
Biotechnology analyst John S. Sonnier at Prudential Equity Group said in a research note that the FDA apparently did not request additional animal studies, or raise concerns about Neose's method of producing the protein, or the basic technology. "At this time, we do not expect this delay to have a significant impact on development time lines," he said.
Sonnier said Neose was developing two other undisclosed proteins that "may have the potential to be partnered" with companies. "We view partnering as an important strategy for Neose to get more drug candidates into clinical trials, while sharing the costs and risks of development," he said.
Shares of Neose closed down 81 cents, or 19.47 percent, at $3.35 on the Nasdaq yesterday.
Contact staff writer Linda Loyd at 215-854-2831 or email@example.com.