Patheon will support the production of the Sollpura clinical drug product for Anthera Pharmaceuticals‘ Phase III registration trial. Sollpura is an investigational, soluble, stable and non-porcine enzyme product intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas.
“This agreement represents the culmination of years of effort by Eli Lilly following their discussion with the FDA in 2010 to develop a next-generation therapy to address the unmet needs of patients with EPI as a result of cystic fibrosis,” said Chuck Olson, head of Liprotamase Development at Anthera. “With this agreement, we’ve taken the first step towards delivering a soluble and stable, sachet-based, non-porcine Pancreatic Enzyme Replacement Therapy to patients burdened by currently available therapies. We look forward to working with Patheon, an experienced CMO, as we strive to bring this much-needed therapy to patients.”
“Our agreement with Anthera illustrates the continued progress toward becoming a fully integrated partner of choice to global pharmaceutical and biotechnology companies,” said Franco Negron, senior vice president, North America commercial operations and global integration at Patheon. “We look forward to working with Anthera on the commercialization of liprotamase.”
EPI is a major cause of serious nutritional deficiencies and long-term development issues, particularly in children with cystic fibrosis. EPI is estimated to afflict more than 150,000 patients in the U.S. alone, with more than $600 million spent on enzyme replacement therapy annually.
The agreement allows for the production of various capsule and sachet formulations and dosage strengths. Discussions with Patheon include the potential to expand into a full supply chain provider for both capsules and sachets, including future commercial manufacturing supply for active pharmaceutical ingredients. Clinical studies with Sollpura are scheduled to begin in 2015.
Patheon is a Founding Member of the Pharma & Biopharma Outsourcing Association.