Anthera Pharmaceuticals has acquired Sollpura from Eli Lilly and plans to license it to newly formed subsidiary Alkira Therapeutics for future development, according to a press release.
Liprotamase (Sollpura) is an investigational pancreatic enzyme replacement therapy (PERT) indicated for exocrine pancreatic insufficiency (EPI). An estimated 150,000 US patients with EPI, particularly children with cystic fibrosis (CF), are at risk for nutritional deficiencies and long-term developmental problems, and more than $600 million is spent on PERT annually, the release said.
“It is potentially the first soluble, stable and nonporcine-derived enzyme product to offer a novel solution to patients who are unable to maintain appropriate nutritional health with existing enzyme therapies,” Paul F. Truex, president and CEO of Anthera, said in the press release.
The drug is chemically ideal for powder formulations and will enable patients who depend on nasogastric tubes or have difficulty swallowing pills to administer treatment via capsule or sachet, Truex said.
“We are pleased to see liprotamase resume development following the efforts of Eli Lilly to address feedback from the FDA,” Robert J. Beall, PhD, president and CEO of the Cystic Fibrosis Foundation, said in the release. “Nutrition is extremely important for better, long-term health outcomes for people with CF, and the availability of a nonporcine enzyme replacement therapy would be a valuable addition for CF patients.”
A phase 3 clinical trial of liprotamase is scheduled for mid 2015.