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Panel says Lilly’s Solpura isn’t ready for approval

January 12, 2011

Eli Lilly and Co. failed to win a U.S. advisory panel’s recommendation to introduce the first pancreatic enzyme that isn’t derived from pig parts.

The risks of Lilly’s Solpura don’t outweigh its benefits in patients with cystic fibrosis or other conditions that impede digestion, outside advisers to the Food and Drug Administration determined in a 7-4 vote Wednesday with one abstention. The panel also recommended that more studies be done on the drug’s safety and effectiveness.

Lilly got Solpura, chemically known as 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, Ill.-based Abbott Laboratories; Pancreaze from New Brunswick, New Jersey-based Johnson & Johnson; and Zenpep from Amsterdam-based Eurand NV.

“A head-to-head control with current preparations is probably a requirement” before Solpura can be approved, said panel member Mark Lowe, a professor of pediatrics at the University of Pittsburgh Medical Center.

While the FDA usually follows the panel recommendations, it isn’t required to do so.

“We appreciate the feedback the committee has provided, and we will continue to work with the FDA to address the questions raised in the meeting as the agency moves toward a final decision,” Eiry Roberts, a Lilly vice president, said in a statement. “We remain confident in the clinical trial package submitted to the FDA in support of the liprotamase application.”

Solpura, made up of enzymes derived from microbiology, may reduce the risk of exposure to viruses compared with other enzyme replacement therapies because it’s not made from pigs. FDA staff raised concerns in a report this week that Solpura 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.

In cystic fibrosis, a buildup of thick mucus in the pancreas prevents enzymes that break down food from reaching the small intestine. Inflammation or infection of the pancreas can also interrupt the work of these enzymes, leading to vitamin deficiency and malnutrition.

The FDA review tests Lilly’s strategy of using small deals to replace products valued at almost half its revenue that are set to lose patent protection by 2013. Patents expire next year for Lilly’s top-selling antipsychotic Zyprexa, and in 2013 for the antidepressant Cymbalta and insulin product Humalog. The three drugs are Lilly’s biggest sellers with $9.95 billion in sales in 2009, or 46 percent of the company’s total revenue.

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