Regulators hand Eli Lilly another new drug rejection

Eli Lilly suffered yet another setback at the hands of U.S. regulators late on Friday. The FDA told Lilly that it would need to conduct another study of a new treatment designed to help a group of patients with a pancreatic disorder before it could expect an approval.

Liprotamase, which was developed by Lilly subsidiary Alnara to help patients digest food, was intended to become the first such drug not made from pig enzymes. Instead it was designed from microbial enzymes. Reuters noted that analysts at Citi had projected peak potential earnings of $300 million. But it may be quite some time before the pharma company gets to test its sales potential.

News of the delay came as no great surprise. Investigators lost a 9-3 vote by an expert panel which remained largely unconvinced that patients taking the therapy would get the nutrients they needed. Still, the rejection marks another failure for Lilly, which has shunned big mergers as CEO John Lechleiter remains convinced that the company can develop important new therapies to replace the blockbusters about to lose patent protection.

"Lilly is looking forward to further discussion with the FDA to address the items outlined in the letter and provide the requested information as quickly as possible," said Eiry Roberts, M.D., who's in charge of liprotamase product development at Lilly. "We are committed to working with the agency and the cystic fibrosis community to make this important treatment option available to patients."

- take a look at the Lilly release
- here's the Reuters story