Lonza and Alnara Pharmaceuticals (Alnara) have signed an agreement to manufacture Alnara’s lead product liprotamase. Liprotamase is a novel, oral, pancreatic enzyme replacement therapy (PERT) for patients with pancreatic insufficiency. The agreement will support Alnara’s New Drug Application (NDA) filing for liprotamase and the production of launch quantities of the product.
As per the agreement, Lonza will provide microbial fermentation, process optimisation, technical and regulatory support. Reportedly, all related production will be conducted in Lonza’s FDA registered facility in Kourím, Czech Republic.
Uwe Bohlke, COO of Lonza Custom Manufacturing, Exclusive Synthesis, said: “We are happy to enter into this agreement with Alnara. This collaboration continues our efforts to produce liprotamase. Working together with Alnara we have reached an important milestone in the launch of liprotamase.”
Alexey Margolin, president and CEO of Alnara, said: “Lonza is the premier company in the manufacture of custom protein therapeutics and the ideal partner to manufacture liprotamase since consistent batch-to-batch production is a benefit of the microbial source and Alnara’s proprietary technology. Now that we have completed the liprotamase clinical development program, this agreement supports our commercialisation efforts as we prepare to submit an NDA and bring this product directly to pancreatic insufficiency patients living with Cystic Fibrosis (CF) and other diseases. We believe liprotamase will offer advantages to physicians and patients, and has the potential to be the first significant advance to treat pancreatic insufficiency in 30 years.”