Lilly Must Do Study on Liprotamase Before FDA Approval

Eli Lilly & Co. (LLY) must conduct another clinical trial before U.S. regulators will consider approving its pancreatic enzyme replacement drug, the company said.

The Food and Drug Administration made the request in a complete response letter to the company, Indianapolis-based Lilly said today in a statement. The treatment, liprotamase, is used to replace a digestive enzyme lacking in patients with cystic fibrosis, pancreatitis, and pancreatectomy. The biologically engineered drug isn’t derived from pig parts.

Lilly faces expiring patents next year for its top-selling drug, the antipsychotic Zyprexa, and in 2013 for the antidepressant Cymbalta and insulin product Humalog. The three drugs generated $10.5 billion in 2010 sales, or 46 percent of the company’s total revenue.

“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,” Eiry Roberts, a Lilly vice president, said in the statement.

An FDA advisory panel recommended against approving liprotamase in January, saying the risks of the drug outweighed its benefits. An FDA staff report had raised concerns that the drug doesn’t appear to increase fat absorption as much as the older products and its benefits may not be clinically meaningful or able to be extrapolated to patients of all ages.

Lilly got liprotamase in its purchase of closely held Alnara Pharmaceuticals Inc. in July for as much as $380 million. The drug was designed to compete with Creon, from Abbott Park, Illinois-based Abbott Laboratories; Pancreaze from New Brunswick, New Jersey-based Johnson & Johnson (JNJ); and Zenpep from Amsterdam-based Eurand NV.

To contact the reporter on this story: Drew Armstrong in Washington at darmstrong17@bloomberg.net;

To contact the editors responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net; Reg Gale in New York at rgale5@bloomberg.net