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.
CONTACT:
|
Dennis Lutz of
Anthera Pharmaceuticals, Inc., dlutz@anthera.com or
510.856.5598.
|
|
Tyler Gronbach for
Patheon, tyler.gronbach@patheon.com or 919-226-3201
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SOURCE Anthera Pharmaceuticals, Inc.