Anthera and Patheon Sign Manufacturing Agreement for Liprotamase Phase III Registration Trial

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Nov 20, 2014, 11:00 ET

HAYWARD, Calif., Nov. 20, 2014 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) announced today 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 – see below).

Sollpura is an investigational soluble, stable and non-porcine enzyme product 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.

"This agreement represents the culmination of years of effort by Eli Lilly following their discussion with the US FDA in 2010 to develop a next-generation therapy to address the unmet needs of patients with EPI as a result of cystic fibrosis," said Chuck Olson, head of Liprotamase Development. "With this agreement, we've taken the first step towards delivering a soluble and stable, sachet-based, non-porcine Pancreatic Enzyme Replacement Therapy to patients burdened by currently available therapies. We look forward to working with Patheon, an experienced contract manufacturing organization, as we strive to bring this much-needed therapy to patients."

EPI is a major cause of serious nutritional deficiencies and long-term development issues, particularly in children with cystic fibrosis. EPI is estimated to afflict more than 150,000 patients in the United States alone, with more than US$600 million spent on enzyme replacement therapy annually.

"Our agreement with Anthera illustrates the continued progress toward becoming a fully integrated partner of choice to global pharmaceutical and biotechnology companies," said Franco Negron, senior vice president, North America commercial operations and global integration at Patheon. "We look forward to working with Anthera on the commercialization of liprotamase."

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.

About SOLUTION

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. Further information about the SOLUTION clinical trial is available on ClinicalTrials.gov at http://clinicaltrials.gov/ct2/show/NCT02279498?term=liprotamase&rank=4.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis.

About Patheon®

Patheon® is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms, including small molecule API and biologic drug substances. Patheon, a business unit of DPx Holdings B.V., encompasses the combined commercial manufacturing capabilities and pharmaceutical product development services, as well as offers a full array of biologic services and pharmaceutical active pharmaceutical ingredients (API) development. Patheon is #1 in product development services, #2 in commercial scale product manufacturing and is #1 in quality. For more information, visit http://www.patheon.com .

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2013 and Quarterly Report on Form 10-Q for the quarters ended March 31, June 30, 2014 and September 30, 2014. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.