Eurand Pharmaceuticals, Inc., a subsidiary of global specialty
pharmaceutical company Eurand N.V. (NASDAQ: EURX), today announced
additional data from a post-hoc analysis of a Phase III clinical
trial with ZENPEP® (pancrelipase) Delayed-Release Capsules, an
FDA-approved pancreatic enzyme product (PEP) for the treatment of
exocrine pancreatic insufficiency (EPI) in patients with cystic
fibrosis (CF) or other conditions. The study results demonstrate
that patients with EPI due to CF can be transitioned effectively
from their previous PEPs to FDA-approved ZENPEP. The data are being
presented today at the 33rd European Cystic Fibrosis Society (ECFS)
Conference in Valencia, Spain.
Results from a post-hoc analysis of a Phase III randomized,
double-blind, placebo-controlled crossover study in 34 patients
with EPI due to CF show that patients experienced a significant and
rapid symptom improvement when switched from their previous PEP to
ZENPEP at a comparable daily dose.
"These findings come at a critical time for physicians and their
patients affected by the FDA's decision to require manufacturers of
unapproved PEPs to cease shipment in accordance with the agency's
April 28, 2010 deadline," said Ruth Thieroff-Ekerdt, M.D., Chief
Medical Officer, Eurand Pharmaceuticals. "For those patients who no
longer have access to their previously prescribed PEPs, ZENPEP has
proven clinical safety and effectiveness in the treatment of
pancreatic insufficiency due to CF and other diseases."
Overfill and dosing variability among unapproved PEPs may
complicate treatment of EPI. In 2004, the FDA conducted a review of
pancreatic enzyme products and found that none of the
then-currently marketed PEPs were able to demonstrate consistent
and predictable safety and effectiveness. As a result, the FDA
mandated that all PEPs be formulated to 100% of their labeled
lipase dose with consistent quality, potency and stability.
ZENPEP has been evaluated in clinical studies in adults and
children as young as one year old. ZENPEP is offered in four dosage
strengths -- 5,000, 10,000, 15,000 and 20,000 units of lipase -- to
allow for precise dosing and for potentially reduced pill burden,
and to meet the varied needs of infants, toddlers, adolescents and
adults with EPI. In addition, the contents of ZENPEP capsules may
be opened and sprinkled on soft acidic foods such as apple sauce.
This convenient option is a key attribute to address the needs of
patients who may have difficulty swallowing capsules, such as very
young patients or certain older patients.
ZENPEP European Clinical Development
Eurand intends to develop ZENPEP for the European market, where
the currently marketed PEPs present issues (i.e., loss of enzyme
activity over time, overfill, and potential safety problems)
similar to unapproved PEPs in the U.S. In late 2009, the European
Medicines Agency (EMA) finalized its draft guidelines on the
clinical development and evaluation of medicinal products,
including PEPs, for the treatment of cystic fibrosis. Based on
these guidelines and the feedback Eurand received from the EMA on
the clinical and regulatory path forward for ZENPEP, the Company
anticipates initiating a Phase III study in Europe in the second
half of 2010.
The EMA has deemed ZENPEP eligible for evaluation of the
marketing authorisation application under the Centralised
Procedure, which enables a single marketing authorisation that is
valid across the European Union and provides the potential for 10
years of marketing exclusivity once the product is approved. The
Company believes that ZENPEP potentially could be the first product
to be filed under the Centralised Procedure since the EMA
guidelines were issued. Eurand plans to out-license the
distribution rights for this product in Europe and Asia, and
discussions are ongoing with potential partners in those
regions.
About Exocrine Pancreatic Insufficiency
(EPI)
Exocrine Pancreatic Insufficiency (EPI) is the inability to
properly digest food due to a lack of digestive enzymes made by the
pancreas. EPI can result from a number of diseases, including
cystic fibrosis, pancreatic cancer, gastrointestinal surgery, and
chronic pancreatitis. The FDA estimates that more than 200,000
Americans suffer from EPI. If left untreated, EPI causes
malnutrition and, especially in CF patients, impaired growth in
children, compromised immune response and shortened life
expectancy.
Important Safety Information
ZENPEP has been approved with a Risk Evaluation and Mitigation
Strategy (REMS) to ensure that the benefits of the drug outweigh
its risks. As part of the REMS, a Medication Guide with important
dosing and safety information about ZENPEP will be handed out with
each new prescription and refill.
The REMS and Medication Guide address the risk associated with
the use of ZENPEP, including fibrosing colonopathy, a rare, serious
adverse reaction that has been reported following treatment with
high-dose use of pancreatic enzyme replacement therapy in the
treatment of cystic fibrosis patients usually over a prolonged time
period. The total daily dose of ZENPEP should not exceed 10,000
lipase units/kg of body weight/day, and caution should be used with
doses exceeding 2,500 lipase units/kg of body weight per meal.
Also, there is a theoretical risk of transmission of viral disease,
since ZENPEP, as other porcine-derived pancreatic enzymes, is
sourced from pancreatic tissue from swine used for food
consumption. No cases of transmission of an infectious illness
associated with the use of porcine pancreatic extracts have been
reported.
Care should be taken to ensure that ZENPEP is not chewed or
retained in the mouth to avoid irritation of oral mucosa and/or
loss of enzyme activity, and the capsules or beads should be
swallowed immediately with adequate amounts of liquid. Caution
should be exercised when using ZENPEP in patients with gout, renal
impairment, or hyperuricemia; porcine-derived pancreatic enzyme
products may increase blood uric acid levels. Caution should be
exercised for patients with known allergies to proteins of porcine
origin. In rare instances, severe allergic reactions including
anaphylaxis, asthma, hives, and pruritus have been reported with
other pancreatic enzyme products with different formulations of the
same active ingredient, pancrelipase, as that of ZENPEP.
In clinical trials assessing the short-term safety of ZENPEP,
the incidence of adverse events (regardless of causality) was
similar during double-blind ZENPEP treatment and placebo treatment.
The most commonly reported adverse events occurring in at least two
patients ( > / = 6% of patients) included: abdominal pain,
flatulence, headache, cough, decreased weight, early satiety, and
contusion. The type and incidence of adverse events were similar in
children and adults.
For complete information about safety, warnings and precautions
for ZENPEP, please see full Prescribing Information and Medication
Guide at www.zenpep.com.
About Eurand
Eurand is a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary pharmaceutical
technologies. Eurand has had six products approved by the FDA since
2001 and has a pipeline of product candidates in development for
itself and its collaboration partners. Its technology platforms
include bioavailability enhancement of poorly soluble drugs, custom
release profiles and taste-masking orally disintegrating tablet
(ODT) formulations.
Eurand is a global company with facilities in the U.S. and
Europe. For more information, visit www.eurand.com.
Forward-Looking Statement
This release and oral statements made with respect to
information contained in this release, including statements about
the potential of ZENPEP to treat Exocrine Pancreatic Insufficiency,
constitute forward-looking statements. Such forward-looking
statements include those which express plan, anticipation, intent,
contingency, goals, targets or future development and/or otherwise
are not statements of historical fact. The words "expects,"
"potentially," "anticipates," "could," "calls for" and similar
expressions also identify forward-looking statements. These
statements are based upon management's current expectations and are
subject to risks and uncertainties, known and unknown, which could
cause actual results and developments to differ materially from
those expressed or implied in such statements. Factors that could
affect actual results include risks associated with our ability to
market, commercialize and achieve market acceptance for ZENPEP or
to develop or partner any of our other products. A non-exclusive
list of important factors that may affect future results may be
found in Eurand's filings with the Securities and Exchange
Commission, including its annual report on Form 20-F and periodic
reports on Form 6-K. Investors should evaluate any statement in
light of these important factors. Forward-looking statements
contained in this press release are made as of this date, and we
undertake no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Actual events could differ materially from those
anticipated in the forward-looking statements.
Investor Contact: Bill Newbould Vice President, Investor
Relations Eurand N.V. +1 267-759-9335 Email Contact Media
Contacts: Jayme Maniatis/Rachel Gross Schwartz Communications
+1 781-684-0770 Email Contact
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