Eli Lilly has sold liprotamase to Anthera Pharmaceuticals, three years after the FDA halted development of the investigational pancreatic enzyme replacement therapy (PERT) through a complete response letter that followed an advisory committee recommendation against approval of the compound. The price was not disclosed.
Anthera said yesterday it will sublicense to a new subsidiary, Alkira Therapeutics, all development and registration activities and IP rights for the compound, now trade-named Sollpura®, then secure funding to advance the experimental therapy into Phase III trials in the U.S. and Europe next year. Alkira will also make all future milestone payments under the parent company’s license agreement with Lilly upon product approval and annual sales achievements, as well as royalties tied to achieving sales thresholds of cumulative net sales of Sollpura.
Anthera also named Chuck Olson, D.Sc., as president of Alkira. He will oversee development activities for Sollpura, including product manufacturing for the upcoming phase III clinical trial, set to begin in mid-2015.
Sollpura is a soluble, stable, and nonporcine derived enzyme product designed to treat patients with low digestive enzyme levels or “exocrine pancreatic insufficiency” (EPI) due to cystic fibrosis and other disorders. EPI patients experience low absorption of fat and other nutrients due to a reduction of digestive enzymes produced by the pancreas.
“Sollpura's chemical characteristics, unlike currently available PERTs, make it ideal for powder formulation as either a capsule or sachet product which can be conveniently co-administered with a variety of food products,” Paul F. Truex, Anthera’s president and CEO, said in a statement. “Our intention with Sollpura is to provide a new convenient choice for adults and children with cystic fibrosis who either have difficulty in swallowing pills or are forced to use nasogastric tubes to ensure appropriate absorption of nutrients.”
The experimental drug ran into trouble with FDA in 2011. In January of that year, the agency’s Gastrointestinal Drugs Advisory Committee rejected the finding that liprotamase’s benefits outweighed its risks, arguing that additional efficacy data was needed before it could conclude that it worked in patients better than existing porcine-derived pancreatic enzyme products. The advisory panel brushed aside pleas from patients and their families to approve the investigational treatment, with several members calling for trials that compared liprotamase with existing treatments.
Lilly responded at the time by expressing confidence in its clinical trial data while promising to work with the FDA to address the committee’s questions. But in April 2011, Lilly said it received a complete response letter from the FDA communicating the agency’s view that the company needed to conduct an additional clinical trial before re-submitting the drug for review. More than a year later during the fourth quarter of 2012, Lilly recorded a $122.6 million charge related to an intangible asset impairment for liprotamase.
Since then, however, Lilly and the FDA appear to have worked to resolve their differences: “We are pleased to see liprotamase resume development following the efforts of Eli Lilly to address feedback from the U.S. Food and Drug Administration,” Robert J. Beall, Ph. D, president and CEO of the Cystic Fibrosis Foundation, said in the statement.
Liprotamase was originally the lead product of Alnara Pharmaceuticals, with Lilly taking over development of the experimental drug after acquiring Alnara in 2010 for an undisclosed price.