CF Foundation Finds Collaborator to Ensure Development of Important Pancreatic Enzyme
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In a Foundation investment worth up to $3 million, Alnara Pharmaceuticals Inc., a Massachusetts-based pharmaceutical company, will complete the ongoing Phase III long-term safety study of liprotamase. Following completion of the study, Alnara will complete clinical and regulatory activities needed to file a New Drug Application with the U.S. Food and Drug Administration. The company is committed to bringing this important product to patients with CF.

Liprotamase was previously in development with Altus Pharmaceuticals Inc. and was known as ALTU-135 and Trizytek.

“The Cystic Fibrosis Foundation is excited to enter into a licensing agreement with Alnara for the development of liprotamase, which has the potential to be the first porcine-free pancreatic enzyme therapy for CF patients with pancreatic insufficiency,” said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. “We look forward to working with Alnara to quickly finish the development of liprotamase and bring this promising new treatment option to patients with cystic fibrosis.”

The Development History of Liprotamase

Liprotamase, which has been in development since 2002, was originally discovered and tested by Altus Pharmaceuticals. Unfortunately, due to financial difficulties, Altus discontinued development in January 2009. Unwilling to let this important therapy languish, the Foundation retrieved rights to the potential drug from Altus, maintained its clinical progress and searched for a company to see the enzyme through the approval process.

The Foundation selected Alnara because of its unique experience with the pancreatic enzyme therapies: two key members of management were involved in developing the original product at Altus. Alnara also plans to develop a pediatric liquid form of the pancreatic enzyme.

Cystic Fibrosis and Pancreatic Insufficiency

Pancreatic insufficiency occurs in approximately 90 percent of people with cystic fibrosis and is treated with pancreatic enzymes that aid digestion and improve growth. Liprotamase is unique and important because, unlike other pancreatic enzymes currently available, it is derived from non-porcine sources.

In addition, liprotamase offers potential advantages over the current standard of care. Today, people with CF must take multiple capsules-sometimes four or five-with every meal or snack. In contrast, with liprotamase, patients can take one small capsule with every meal or snack.

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