Anthera Announces $3 Million Research Award from Cystic Fibrosis Foundation Therapeutics for Development of Sollpura - a Novel Enzyme Therapy

19 Mar, 2015, 15:00 ET from Anthera Pharmaceuticals, Inc.

HAYWARD, Calif., March 19, 2015 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced it has received an award from Cystic Fibrosis Foundation Therapeutics Inc. of up to $3 million to support the manufacturing and clinical development of Anthera's novel pancreatic enzyme replacement therapy, Sollpura™ (liprotamase).   Cystic Fibrosis Foundation Therapeutics is a non-profit affiliate of the Cystic Fibrosis Foundation.

Liprotamase is an investigational soluble, stable and non-porcine enzyme therapy intended for people with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI) due to Cystic Fibrosis and other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas. According to the Cystic Fibrosis Foundation, about 90 percent of people with cystic fibrosis have pancreatic insufficiency and need to take pancreatic enzymes with every meal and most snacks in order to absorb vital nutrients. 

Anthera plans to begin a Phase 3 registration trial for liprotamase (SOLUTION), in the third quarter of 2015. If the results are positive, Anthera will complete clinical and regulatory activities needed to file a New Drug Application with the U.S. Food and Drug Administration.

"We are excited about the possibility of offering an alternative pancreatic enzyme therapy to people with CF," said Paul F. Truex, Anthera's President and Chief Executive Officer. "Support from Cystic Fibrosis Foundation Therapeutics speaks to the importance of developing liprotamase and the organization's  extensive clinical trials network will be indispensable as we advance this therapy."

About Anthera Pharmaceuticals

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

About Sollpura (liprotamase)

Sollpura is a 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. The Cystic Fibrosis Foundation has been involved with liprotamase throughout its development.

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, 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.

CONTACT: Dennis Lutz of Anthera Pharmaceuticals, Inc., dlutz@anthera.com or 510.856.5598.

 

SOURCE Anthera Pharmaceuticals, Inc.



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