Anthera, Patheon to Co-Manufacture Sollpura for CF Phase 3 Trial
Anthera Pharmaceuticals, Inc., a biopharmaceutical company that specializes in research and development of novel treatments for serious and fatal diseases such as lupus, lupus with nephrotic affectation, and exocrine pancreatic insufficiency (EPI) secondary to cystic fibrosis (CF), has just announced that it has partnered with Patheon®, a contract development and commercial manufacturing (CDMO) service provider, for Sollpura®’s (liprotamase) Phase III registration trial called SOLUTION, designed to evaluate the drug’s efficacy and safety compared to other available treatments for EPI. The study is currently evaluating 126 CF patients.
Exocrine pancreatic insufficiency (EPI) is a deficiency of the exocrine pancreatic enzymes, which causes maldigestion. Common symptoms include: abdominal pain and tenderness, loss of appetite, feelings of fullness, weight loss and diarrhea. It is one of the leading causes of severe malnutrition, and growth and developmental delay in children with CF, and is estimated to affect over 150,000 patients in the US.
Chuck Olson, the head of Liprotamase Development, said this new partnership is a product of a 2010 meeting between pharmaceutical company Eli Lilly and the US Food and Drug Administration, during which the agency stressed the unmet need for newer treatments for CF-related EPI. Anthera is looking forward to working with Patheon in bringing this highly stable and soluble, non-porcine Pancreatic Enzyme Replacement Therapy, conveniently packaged in a sachet, to the market.
“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, the senior vice president, North America commercial operations and global integration at Patheon. “We look forward to working with Anthera on the commercialization of liprotamase.”
According to the agreement, the two companies will be manufacturing capsule and sachet formulations of Sollpura® in various dosages. Anthera has also discussed the possibility of expanding the agreement with Patheon to make it a full supply chain provider for both formulations, as well as future commercial manufacturing supply for active pharmaceutical ingredients. Clinical research programs involving Sollpura® are set to launch in 2015. The success of SOLUTION will support approval of a New Drug Application with the US FDA. To learn more about this clinical trial, visit ClinicalTrials.gov.