Patheon To Manufacture Anthera's Liprotamase For Exocrine Pancreatic Insufficiency

Anthera Pharmaceuticals has contracted with Patheon, a contract development and manufacturing organization (CDMO), to manufacture Sollpura (liprotamase).The companies announced the agreement in a press release, stating that Patheon will manufacture quantities suitable for Anthera's Phase 3 registration trial. Anthera acquired Sollpura from Eli Lilly in July 2014. The agent shows promise in treating low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis.

Chuck Olson, head of Liprotamase Development at Eli Lilly, said, "This agreement represents the culmination of years of effort by Eli Lilly following their discussion with the U.S. FDA in 2010 to develop a next-generation therapy to address the unmet needs of patients with EPI as a result of cystic fibrosis.”

Patheon and Anthera Agreement

Patheon has agreed to produce different formulations of Sollpura, including capsules, sachets, and dosage strengths. Additionally, the companies are in discussions for Patheon to scale manufacturing for commercialization of the final product and/or the active pharmaceutical ingredients (APIs). The Sollpura trial is expected to commence in 2015.

Sollpura

Sollpura is a non-porcine enzyme product containing three digestive enzymes, including lipase, protease, and amylase. Due to cystic fibrosis, EPI features low digestive enzyme levels and low absorption of fat. Liprotamase enzymes aid in digestion and absorption of nutrients. EPI patients number approximately 150,000 in the U.S., a majority of which are children. Anthera estimates that $600 million is spent annually on enzyme replacement therapy.

Sollpura Trial

The SOLUTION trial is a Phase 3 study comparing Sollpura with a porcine (pig) comparator. Anthera expects to enroll 126 patients and hopes to demonstrate non-inferiority of Sollpura with current pancreatic enzyme replacement therapies. Anthera states that the study is well-designed and if successful, should support a New Drug Application (NDA). Both males and females are eligible to join the study, and patients may be as young as 7 years old. 

The primary outcome measures are the change in Coefficient of Fat Absorption (CFA) from baseline up to eight weeks of stabilized therapy and non-inferiority of liprotamase to comparator. The secondary outcome measures include safety issues, such as adverse events or laboratory abnormalities. The study is expected to begin in June 2015 and end in January 2017 for the primary outcome measure.