Date: 2014-11-20
Type of information: Production agreement
Compound: Sollpura®
Company: Anthera Pharmaceuticals (USA - CA) Patheon® division of DPx Holdings (USA - NC)
Therapeutic area: Metabolic diseases - Rare diseases
Type agreement: manufacturing production
Action mechanism: Sollpura® is an investigational soluble, stable and non-porcine enzyme product (liprotamase) intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas.
Disease: Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis
Details: * On November 20, 2014, Anthera Pharmaceuticals announced it has signed a manufacturing and supply agreement with the Patheon® division of DPx Holdings B.V. The contract provides for Patheon to support the production of the Sollpura® clinical drug product for Anthera\'s Phase III registration trial (SOLUTION clinical trial). The agreement allows for the production of various capsule and sachet formulations and dosage strengths. Discussions with Patheon include the potential to expand into a full supply chain provider for both capsules and sachets, including future commercial manufacturing supply for active pharmaceutical ingredients. Clinical studies with Sollpura are scheduled to begin in 2015. SOLUTION is a Phase 3, randomized, open-label, assessor-blind, noninferiority, active-comparator study evaluating the efficacy and safety of liprotamase in patients with cystic fibrosis-related exocrine pancreatic insufficiency. The 126-patient, Phase III SOLUTION clinical trial will evaluate the non-inferiority of liprotamase compared with current pancreatic enzyme replacement therapies in a population enriched for PERT responders. We believe the proposed design of the SOLUTION trial, including inclusion/exclusion criteria, blinding, and efficacy variables, constitutes an adequate and well-controlled trial, which if successful, will support approval of an NDA. (NCT02279498)
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