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.
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SOURCE Anthera Pharmaceuticals, Inc.