Recombinant oral therapy comprises lipase, protease, and amylase.
Lilly is buying Alnara Pharmaceuticals in order to get a foothold in the enzyme replacement therapy market. The acquired firm’s lead product liprotamase is an oral, nonporcine pancreatic enzyme replacement therapy (PERT), which is currently under FDA review for the treatment of exocrine pancreatic insufficiency.
“The acquisition of Alnara provides Lilly with a promising entry into enzyme replacement therapy,” commented Bryce Carmine, executive vp of Lilly and president of Lilly BioMedicines. “Alnara has been very successful in the development of liprotamase, as indicated by its recent submission to FDA, and we look forward to partnering with Alnara’ experts during the regulatory review process.”
Liprotamase comprises the digestive enzymes lipase, protease, and amylase, and is produced using recombinant technology. It has been formulated so patients need only take 1–2 small capsules per meal or snack, Alnara states.
The firm’s process development and production partner for liprotamase is Lonza, which has provided the microbial fermentation, process optimization, technical, and regulatory support for generating the product. Lonza is manufacturing Liprotamase at its FDA-registered facility in the Czech Republic.
The development of liprotamase over the last 12 months has been carried out by Alnara in collaboration with Cystic Fibrosis Foundation Therapeutics, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation (CFF). The product was acquired by Alnara from the Cystic Fibrosis Foundation (CFF) in 2009, which earlier the same year had taken the product over from Altus Pharmaceuticals.
The clinical development program for liprotamase included some 500 patients with exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis or pancreatectomy. Alnara claims the Phase II and Phase III clinical trials represent the largest body of prospective clinical data for any pancreatic enzyme, with both pivotal efficacy trials demonstrating that the treatment significantly improves both fat and protein absorption.